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1. Aetiology and outcome of pneumoniae in HIV-positive patients in the antiretroviral era .

Author: Leoni MC, Mussa M, Chieffo G, Minoli L, Seminari E, Provini M, De Silvestri A, and Marone P
Subjects: Adult, Bacteria classification, Female, Fungi classification, Humans, Lung pathology, Male, Middle Aged, Pneumonia microbiology, Pneumonia virology, Radiography, Thoracic, Treatment Outcome, Viruses classification, Bacteria isolation & purification, Fungi isolation & purification, HIV Infections complications, Pneumonia epidemiology, Pneumonia etiology, Viruses isolation & purification
Published: 2017
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2. Neuropsychological evaluation and follow up in jcv- and non-jcv-related leukoencephalopathies in HIV infection.

Author: Zucchella C, Sinforiani E, Tavazzi E, Del Bue S, Novati S, Maserati R, Ceroni M, Bastianello S, Minoli L, Ferrante P, and Marchioni E
Subjects: Adult, Aged, Antiretroviral Therapy, Highly Active, Female, HIV Infections drug therapy, HIV Infections virology, Humans, Leukoencephalopathy, Progressive Multifocal drug therapy, Leukoencephalopathy, Progressive Multifocal virology, Male, Middle Aged, Neuropsychological Tests, HIV Infections psychology, JC Virus isolation & purification, Leukoencephalopathy, Progressive Multifocal psychology
Abstract: The introduction of highly active antiretroviral therapy does not seem to have altered the incidence of progressive multifocal leukoencephalopathy (PML) in HIV infection. Moreover, the occurrence of a HIV-related leukoencephalopathy, called not determined leukoencephalopaties (NDLE), has been reported. As neuropsychological impairment remains highly prevalent in HIV infection, the aim of this study is to describe the neuropsychological profile of PML and NDLE patients, analyzing the time-related changes. Clinical and neuropsychological data from 32 patients (17 PML, 15 NDLE) were compared with two control groups: (1) asymptomatic HIV+ patients without magnetic resonance imaging evidence of leukoencephalopathy; (2) age-/gender-/education-matched healthy subjects. Patients with rapidly worsening PML were significantly impaired on all neuropsychological tests, while PML with more benign course and NDLE groups showed a dysexecutive pattern of impairment. Asymptomatic HIV+ subjects showed mild and isolated cognitive deficits, without functional impact. Cognitive impairment should therefore be considered a key feature from HIV infection diagnosis.
Published: 2011
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3. Acute transient inflammatory leukoencephalopathy in HIV.

Author: Tavazzi E, Magrassi L, Maccabruni A, Bargiggia V, Pichiecchio A, Delbue S, Ferrante P, Minoli L, and Marchioni E
Subjects: Adult, Disease Progression, Female, HIV Infections pathology, HIV Seropositivity pathology, Humans, Leukoencephalopathies pathology, HIV Infections complications, HIV Seropositivity complications, Leukoencephalopathies virology
Abstract: HIV-related acute inflammatory leukoencephalopathy of undetermined origin (AIL) is characterized by abrupt onset of symptoms generally associated with focal brain lesions and inflammatory CSF findings. A previously asymptomatic 31-year-old HIV+ woman presented with acute cognitive difficulties, right hemiparesis and dysphasia. Brain MRI showed a large contrast-enhancing lesion in the left frontal lobe; brain biopsy revealed an inflammatory process. No etiological agent was found in blood, CSF or brain tissue. The patient was given systemic steroids and gammaglobulins and put on HAART. Clinical conditions progressively and completely recovered. Further brain MRI showed the shrinkage of the lesion with no contrast enhancement. Our case could be classified as AIL in HIV resembling ADEM pattern and highlights the importance of taking into consideration. ADEM in the diagnostic process of HIV-related leukoencephalopathy even if the typical features are lacking, as immunodeficiency could modify both presentation and disease course.
Published: 2011
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4. Long-term CD4+ T-cell count evolution after switching from regimens including HIV nucleoside reverse transcriptase inhibitors (NRTI) plus protease inhibitors to regimens containing NRTI plus non-NRTI or only NRTI.

Author: Torti C, d'Arminio-Monforte A, Pozniak AL, Lapadula G, Cologni G, Antinori A, De Luca A, Mussini C, Castagna A, Cicconi P, Minoli L, Costantini A, Carosi G, Liang H, and Cesana BM
Subjects: Adult, Antiretroviral Therapy, Highly Active, CD4 Lymphocyte Count, CD4-Positive T-Lymphocytes immunology, Female, Humans, Male, Middle Aged, Retrospective Studies, Time, CD4-Positive T-Lymphocytes drug effects, Drug Substitution, HIV Infections drug therapy, HIV Infections immunology, Protease Inhibitors therapeutic use, Reverse Transcriptase Inhibitors therapeutic use
Abstract: Background: Data regarding CD4+ recovery after switching from protease inhibitor (PI)-based regimens to regimens not containing PI are scarce., Methods: Subjects with virological success on first-PI-regimens who switched to NNRTI therapy (NNRTI group) or to nucleoside reverse transcriptase (NRTI)-only (NRTI group) were studied. The effect of the switch on the ongoing CD4+ trend was assessed by two-phase linear regression (TPLR), allowing us to evaluate whether a change in the CD4+ trend (hinge) occurred and the time of its occurrence. Furthermore, we described the evolution of the frequencies in CD4-count classes across four relevant time-points (baseline, before and immediately after the switch, and last visit). Finally, we explored whether the CD4+ counts evolved differently in patients who switched to NNRTI or NRTI-only regimens by considering: the overall CD4+ trends, the time to CD4+≥ 500/mm3 after the switch, and the area-under-the-curve (AUC) of the CD4+ after the switch., Results: Eight hundred and ninety-six patients, followed for a median of 2,121 days, were included. At TPLR, hinges occurred in 581/844 (68.9%), but in only 40/581 (6.9%) within a time interval (180 days) compatible with a possible relationship to the switch; furthermore, in 19/40 cases, CD4+ counts appeared to decrease after the hinges. In comparison with the NNRTI group, the NRTI group showed CD4+ count greater at baseline (P = 0.0234) and before the switch (P ≤ 0.0001), superior CD4+ T-cell increases after HAART was started, lower probability of not achieving CD4+ ≥ 500/mm3 (P = 0.0024), and, finally, no significant differences in the CD4+ T-cell AUC after the switch after adjusting for possible confounders (propensity score and pre-switch AUC). Persistence at CD4+ < 200/mm3 was observed in 34/435 (7.5%) patients, and a decrease below this level was found in only 10/259 (3.9%) with baseline CD4+ ≥ 350/mm3., Conclusions: Switching from first-line PI to NNRTI- or NRTI-based regimens did not seem to impair CD4+ trend over long-term follow-up. Although the greater CD4+ increases in patients who switched to the NRTI-only regimen was due to higher CD4+ counts before the switch, several statistical analyses consistently showed that switching to this regimen did not damage the ongoing immune-reconstitution. Lastly, the observation that CD4+ T-cell counts remained low or decreased in the long term despite virological success merits further investigation.
Published: 2011
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5. HIV-related acute inflammatory leukoencephalopathy of undetermined origin: review of the literature.

Author: Tavazzi E, Bargiggia V, Pichiecchio A, Delbue S, Maserati R, Bastianello S, Ferrante P, Minoli L, Ricevuti G, Ceroni M, and Marchioni E
Subjects: AIDS Dementia Complex pathology, Acute Disease, Anti-HIV Agents therapeutic use, Brain pathology, Encephalitis drug therapy, Encephalitis pathology, HIV Infections drug therapy, HIV Infections pathology, HIV Seropositivity, Humans, Leukoencephalopathies drug therapy, Leukoencephalopathies pathology, Magnetic Resonance Imaging, Spinal Cord pathology, Terminology as Topic, Tomography, X-Ray Computed, Encephalitis etiology, HIV Infections complications, Leukoencephalopathies etiology
Abstract: HIV-related acute inflammatory leukoencephalopathy of undetermined origin (AIL) has been anecdotally described in literature as being responsible for cognitive and motor deficits. We carried out a review of all the cases of AIL published in literature. Articles were selected according to 2 criteria: acute onset of symptoms; undetermined aetiology and non-fulfilment of multiple sclerosis diagnostic criteria. They were then analyzed in terms of clinical, biological and instrumental features, therapy, diagnostic classification and prognosis. Although rare (21 patients out of about 4,000 publications), AIL is of particular interest, as the comprehension of its mechanisms could give some insight into the direct and immune-mediated actions of HIV within the brain. All the reported patients share several clinical, histopathological, radiological and CSF features, leading to hypothesize a similar aetiopathogenetic mechanism. Conversely, we observed a high heterogeneity of treatment and diagnostic classification, which could have conditioned the broad prognostic variability. The absence of a defined aetiology leads to consider these forms as a particular subgroup of not determined leucoencephalopathies (NDLE), with both MRI and histological pattern dominated by inflammation as distinctive feature.
Published: 2010
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6. Predictors of clinical progression among HIV-1-positive patients starting HAART with CD4+ T-cell counts > or =200 cells/mm3.

Author: Lapadula G, Torti C, Maggiolo F, Casari S, Suter F, Minoli L, Pezzoli C, Di Pietro M, Migliorino G, Ouiros-Roldan E, Ladisa N, Sighinolfi L, Costarelli S, and Carosi G
Subjects: Adult, Cohort Studies, Disease Progression, Female, HIV Infections immunology, HIV Infections mortality, HIV Infections virology, Humans, Male, Prognosis, Anti-HIV Agents therapeutic use, Antiretroviral Therapy, Highly Active, CD4 Lymphocyte Count, HIV Infections drug therapy, HIV-1
Abstract: Background: Baseline and follow-up predictors of new AIDS-defining events (ADE) or death among patients who started HAART with CD4+ T-cell counts > or =200 cells/mm3 have rarely been assessed simultaneously., Methods: A prospective observational cohort study (1996-2002) is reported. HIV-infected patients initiating HAART with a CD4+ T-cell count > or =200 cells/mm3 were studied. Baseline and time-varying factors were tested for the prediction of new ADE/death using Cox regression models., Results: A total of 896 subjects were studied over a median of 5.1 years. The incidence of a new ADE was 1.6 (95% confidence interval 1.3-2.1) per 100 person-years. Among baseline factors, higher CD4+ T-cell counts before HAART were associated with lower risk of ADE/death, but not after adjustment for time-varying factors. On a multivariable analysis including both baseline and time-varying covariates, longer delay from HIV diagnosis to HAART was an independent predictor of ADE/death (per year, hazard ratio [HR] 1.06; P = 0.025) and was independent of CD4+ T-cell count before treatment. Longer time spent with HIV RNA <400 copies/ml (per month, HR 0.96; P = 0.003) and higher latest CD4+ T-cell count (per log2 cells/mm3, HR 0.65; P < 0.001) were found to be protective., Conclusions: Patients with higher CD4+ T-cell counts before HAART initiation had a better prognosis. However, except for the delay in starting HAART, viroimmunological evolution outweighed the effect of baseline factors. Moreover, suppressing HIV replication for as long as possible could improve the clinical outcome. Prospective randomized clinical trials to assess the optimal timing of HAART initiation are both feasible and urgently needed.
Published: 2007

7. Influence of genotype 3 hepatitis C coinfection on liver enzyme elevation in HIV-1-positive patients after commencement of a new highly active antiretroviral regimen: results from the EPOKA-MASTER Cohort.

Author: Torti C, Lapadula G, Puoti M, Casari S, Uccelli MC, Cristini G, Bella D, Pastore G, Ladisa N, Minoli L, Sotgiu G, Caputo SL, Bonora S, and Carosi G
Subjects: Adult, Antiretroviral Therapy, Highly Active, Chemical and Drug Induced Liver Injury blood, Chemical and Drug Induced Liver Injury etiology, Cohort Studies, Female, HIV Infections blood, HIV Infections complications, Hepatitis C blood, Hepatitis C complications, Humans, Male, Proportional Hazards Models, Species Specificity, Alanine Transaminase blood, Anti-HIV Agents therapeutic use, HIV Infections drug therapy, HIV-1, Hepacivirus genetics, Hepatitis C virology
Abstract: Background: The independent role of hepatitis C virus (HCV) genotype 3 in liver transaminase elevation following highly active antiretroviral regimens is still controversial., Methods: Analysis of data from a cohort of 492 HIV/HCV-coinfected patients was conducted using an intention-to-treat approach. Incidence of grade > or = III liver transaminase elevation was estimated per 100 patient-years of follow-up. Univariate and multiple proportional hazards regression analysis of factors that may predict liver enzyme elevation was performed., Results: The incidence of grade > or = III hepatotoxicity was 25 per 100 patient-years among patients coinfected with HCV genotype 3 and 11 per 100 patient-years among those with other genotypes. On multiple proportional hazard regression analysis, time-to-grade > or = III liver enzyme elevation was directly correlated with HCV genotype 3 (hazards ratio [HR]: 2.0, 95% CI: 1.3 to 2.9; P = 0.001), male gender (HR: 2.7; 95% CI: 1.3 to 5.7; P = 0.007), chronic hepatitis B virus infection (HR: 2.9, 95% CI: 1.5 to 5.9; P = 0.002), and alanine aminotransferase level at baseline (per 10 IU/L HR: 1.10; 95% CI: 1.06 to 1.15; P < 0.001). In the same model, higher CD4 T-cell counts at baseline were inversely correlated with risk of hepatotoxicity (HR: 0.998; 95% CI: 0.997 to 0.999; P = 0.036). Moreover, among patients experienced to antiretroviral drugs, previous grade > or = III hepatotoxicity (HR: 2.8; 95% CI: 1.8 to 4.3; P < 0.001) was an adjunctive independent risk factor., Conclusions: HIV-positive patients coinfected with HCV genotype 3 displayed a higher risk of relevant hepatotoxicity, independently from other clinical variables. The impact of HCV genotype outweighed the role of drugs in determining hepatotoxicity.
Published: 2006
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8. The effect of HIV-1 resistance mutations after first-line virological failure on the possibility to sequence antiretroviral drugs in second-line regimens.

Author: Maggiolo F, Ripamonti D, Torti C, Arici C, Antinori A, Quiros-Roldan E, Minoli L, Sighinolfi L, Nasta P, and Suter F
Subjects: Adult, Antiretroviral Therapy, Highly Active, Cohort Studies, Drug Resistance, Endpoint Determination, Female, HIV Infections virology, HIV Protease Inhibitors therapeutic use, HIV-1 genetics, Humans, Italy, Male, Mutation, Retrospective Studies, Thymidine analogs & derivatives, Thymidine genetics, Treatment Outcome, Viral Load, Anti-HIV Agents pharmacology, Anti-HIV Agents therapeutic use, HIV Infections drug therapy, HIV-1 drug effects
Abstract: Background: One of the more vigorous debates in the field of highly active antiretroviral therapy (HAART) is how to start it and what the optimal drug sequence is., Methods: A retrospective cohort analysis was performed. The aim was to evaluate which variables could influence the virological response to second-line genotypic-based HAART in patients with virological documented first-line HAART failure. A positive response was defined as a confirmed HIV RNA level < 50 copies/ml., Results: Two hundred and eight patients were included. Demographic characteristics, risk factors for HIV acquisition, and drugs included in the initial treatment did not significantly influence the considered outcome. According to a multiple logistic model, the presence of thymidine analogue mutations (TAMs) had a negative association with the virological outcome (P = 0.006), whereas the use of a boosted protease inhibitor (PI) in second-line HAART was positively associated with the endpoint (P = 0.001). Patients receiving a genotypic-based second-line HAART containing a boosted PI achieved a viral load < 50 copies/ml in a 74.2% of cases compared with 52.2% of those whose therapy did not contain a boosted PI. This difference was statistically significant (P = 0.002) with an odds ratio (OR) of 2.63 and a 95% confidence interval (CI) ranging from 1.46 to 4.76. This last variable positively influenced the outcome even when the analysis was restricted to patients harbouring a virus presenting TAMs. In this case, second-line HAART was successful in 66.7% of cases with an OR of 3.25 and a 95% CI ranging from 1.28 to 8.25 (P = 0.014)., Conclusions: the wider range of available therapeutic options has made resistance and drug-sequencing considerations a crucial point in selecting first-line HAART. Our data indicate that, by limiting the risk of selecting or accumulating TAMs, it could be possible to save further therapeutic options. In second-line regimens, the higher antiviral effect and genetic barrier of boosted PIs may overcome the limits of the use of NRTI backbones, which retain only a partial effectiveness.
Published: 2006

9. Incidence and risk factors for liver enzyme elevation during highly active antiretroviral therapy in HIV-HCV co-infected patients: results from the Italian EPOKA-MASTER Cohort.

Author: Torti C, Lapadula G, Casari S, Puoti M, Nelson M, Quiros-Roldan E, Bella D, Pastore G, Ladisa N, Minoli L, Sotgiu G, Mazzotta F, Lo Caputo S, Di Perri G, Filice G, Tinelli C, and Carosi G
Subjects: Adult, Alanine Transaminase, Anti-HIV Agents adverse effects, Aspartate Aminotransferases, Chemical and Drug Induced Liver Injury etiology, Cohort Studies, Humans, Incidence, Italy, Liver Function Tests, Middle Aged, Proportional Hazards Models, Retrospective Studies, Risk Factors, Antiretroviral Therapy, Highly Active adverse effects, HIV Infections complications, HIV Infections drug therapy, Hepatitis C complications, Liver drug effects, Liver enzymology
Abstract: Background: The risk of hepatotoxicity associated with different highly active antiretroviral therapy (HAART) regimens (containing multiple-protease inhibitors, single-protease inhibitors or non nucleoside reverse transcriptase inhibitors) in HIV-HCV co-infected patients has not been fully assessed., Methods: Retrospective analysis of a prospective cohort of 1,038 HIV-HCV co-infected patients who commenced a new HAART in the Italian MASTER database. Patients were stratified into naïve and experienced to antiretroviral therapy before starting the study regimens. Time to grade > or =III hepatotoxicity (as by ACTG classification) was the primary outcome. Secondary outcome was time to grade IV hepatotoxicity., Results: Incidence of grade > or =III hepatotoxicity was 17.71 per 100 patient-years (p-yr) of follow up in naïve patient group and 8.22 per 100 p-yrs in experienced group (grade IV: 4.13 per 100 p-yrs and 1.08 per 100 p-yrs, respectively). In the latter group, the only independent factors associated with shorter time to the event at proportional hazards regression model were: previous liver transaminase elevations to grade > or =III, higher baseline alanine amino-transferase values, and use of a non nucleoside reverse transcriptase inhibitor based regimen. In the naive group, baseline aspartate transaminase level was associated with the primary outcome., Conclusion: Use of a single or multiple protease inhibitor based regimen was not associated with risk of hepatotoxicity in either naïve or experienced patient groups to a statistically significant extent. A cautious approach with strict monitoring should be applied in HIV-HCV co-infected experienced patients with previous liver transaminase elevations, higher baseline alanine amino-transferase values and who receive regimens containing non nucleoside reverse transcriptase inhibitors.
Published: 2005
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10. Endocrine pancreatic dysfunction in HIV-infected children: association with growth alterations.

Author: Rondanelli M, Caselli D, Trotti R, Solerte SB, Maghnie M, Maccabruni A, Minoli L, and Ferrari E
Subjects: Blood Glucose, C-Peptide blood, Child, Female, Glucagon blood, HIV Infections physiopathology, Homeostasis, Hormones blood, Humans, Insulin blood, Lipids blood, Male, Prospective Studies, Growth Disorders etiology, Growth Disorders physiopathology, HIV Infections complications, Pancreas physiopathology
Abstract: Background: The pancreatic endocrine system normally guarantees a quick and efficient response to daily metabolic perturbations, but associated data for human immunodeficiency virus (HIV)-infected patients are lacking. A prospective study was performed to evaluate pancreatic endocrine secretion and its possible association with failure to thrive among HIV-infected children., Methods: Fourteen well-nourished, prepubertal, HIV-infected children (6 boys and 8 girls; age range, 5-11 years), none of whom were receiving protease inhibitors, and 16 clinically healthy sex- and age-matched children formed the patient group and the control group, respectively. At yearly follow-up examinations, insulin, glucagon, C-peptide, and glucose levels were measured; the ratio of insulin to glucose, the ratio of insulin to glucagon, and the homeostasis model assessment (HOMA) index were calculated; the glucagon test was administered; and growth hormone, thyroid-stimulating hormone, adrenocorticotropic hormone, cortisol, and lipid patterns were evaluated., Results: Insulin, glucagon, C-peptide, glucose, and HOMA measurements were significantly higher among patients, compared with control subjects, at all 3 follow-ups performed to date. The glucagon test revealed a normal glycemic response in all the healthy control subjects and a significantly impaired response in 11 patients. A significant correlation emerged between the ratio of insulin to glucagon and the growth velocity of HIV-infected children., Conclusion: To our knowledge, the present study provides the first evidence of altered pancreatic endocrine secretion and its association with growth failure among HIV-infected children.
Published: 2004
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11. Immune reconstitution and control of HIV.

Author: Lori F, Maserati R, Lisziewicz J, and Minoli L
Subjects: Humans, Immunity, Innate, Italy, HIV Infections immunology, HIV Infections prevention & control
Published: 2004
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12. Incidence of adipose tissue alterations in first-line antiretroviral therapy: the LipoICoNa Study.

Author: Galli M, Cozzi-Lepri A, Ridolfo AL, Gervasoni C, Ravasio L, Corsico L, Gianelli E, Vaccarezza M, Vullo V, Cargnel A, Minoli L, Coronado O, Giacometti A, Antinori A, Antonucci G, D'Arminio Monforte A, and Moroni M
Subjects: Adipose Tissue physiopathology, Adult, Age Distribution, Cohort Studies, Dose-Response Relationship, Drug, Drug Administration Schedule, Female, HIV Protease Inhibitors administration & dosage, Humans, Incidence, Italy epidemiology, Male, Multivariate Analysis, Probability, Proportional Hazards Models, Retrospective Studies, Risk Assessment, Risk Factors, Severity of Illness Index, Sex Distribution, Adipose Tissue drug effects, Antiretroviral Therapy, Highly Active adverse effects, HIV Infections drug therapy, HIV Protease Inhibitors adverse effects, Lipodystrophy chemically induced, Lipodystrophy epidemiology
Abstract: Background: Adipose tissue alterations (ATAs) are a frequent untoward effect of antiretroviral therapy, the causes of which remain incompletely explained., Objectives: To assess the incidence of ATAs and to identify the associated risk factors in patients infected with human immunodeficiency virus type 1 starting their first-line antiretroviral treatment., Methods: In a multicenter investigation designed to study issues related to the treatment of patients starting antiretroviral therapy, physicians were requested to assess the presence of ATAs at enrollment and every 6 months thereafter. The ATAs were considered altogether and grouped as fat loss (lipoatrophy), adipose tissue accumulation (lipohypertrophy), and combined forms., Results: A total of 655 patients were followed up for a median of 86 weeks; 128 patients (19.6%) were diagnosed as having at least 1 morphologic alteration during the study. Female gender and positivity for hepatitis C virus were independently linked to an increased risk of developing morphologic alterations. Age was another independent correlate of risk of developing ATAs. To have been infected through drug injection was a correlate of reduced risk of ATAs. Stavudine exposure was predictive at borderline statistical significance of lipoatrophy (but not of the other forms), and indinavir exposure was associated with a significantly higher risk of developing combined forms. Patients who started therapy with 2 nucleoside reverse transcriptase inhibitors and subsequently added a protease inhibitor during the follow-up had a significantly higher risk of having ATAs compared with patients who continued taking 2 nucleoside reverse transcriptase inhibitors up to the end of follow-up., Conclusions: Different types of ATAs might derive from distinct pathways and multifactorial causes. Adipose tissue alterations are a frequent and relatively early finding during first-line antiretroviral therapy.
Published: 2002
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13. Early and late effects of highly active antiretroviral therapy: a 2 year follow-up of antiviral-treated and antiviral-naive chronically HIV-infected patients.

Author: Clerici M, Seminari E, Maggiolo F, Pan A, Migliorino M, Trabattoni D, Castelli F, Suter F, Fusi ML, Minoli L, Carosi G, and Maserati R
Subjects: CD4 Lymphocyte Count, CD8-Positive T-Lymphocytes immunology, Chronic Disease, Cytokines metabolism, Follow-Up Studies, HIV Infections immunology, HIV Infections virology, HIV-1, Humans, Interleukin-7 metabolism, Longitudinal Studies, Prospective Studies, Treatment Outcome, Viral Load, Viremia virology, Antiretroviral Therapy, Highly Active, HIV Infections drug therapy
Abstract: Background: Control of HIV replication can be observed in highly active antiretroviral therapy (HAART)-treated and, occasionally, in HAART-naive patients. The immunological correlates of these situations were examined in a longitudinal study., Design: A prospective study. Immunovirological analyses in 16 chronically HIV-infected, HAART-naive patients (time 0) who started HAART. Fifteen patients (short-term HAART) were re-evaluated after 24 months (time 1). Results were compared with those of 30 patients who received HAART for more than 12 months before the study period (long-term HAART) and were analysed at the same timepoints. Fifteen patients who were antiviral therapy naive (naive) at both timepoints were also studied., Results: Over a 24-month period CD4 and CD8 cell counts and viraemia remained unchanged in naive and long-term HAART patients; CD4 cell counts increased and viraemia diminished in short-term HAART individuals. Antigen-stimulated proliferation was unmodified in naive and short-term HAART patients, but improved in long-term HAART individuals. Gp160-stimulated IL-2 and IFN-gamma production was augmented in long-term HAART patients and marginally modified in other patients. IL-7 production was unmodified in naive individuals, augmented in short-term HAART patients, and diminished in long-term HAART patients. Chemokine production was similar in all patients. Naive patients showed the highest CD8 cell counts at both timepoints., Conclusion: HAART has a major impact on the outcome of HIV infection, even if functional immune modulation in HAART-treated patients is evident only after long periods of therapy. Low but detectable HIV replication in HAART-naive patients with preserved immune functions might not be associated with CD4 cell reduction, functional immune defects, or changes in viraemia., (Copyright 2002 Lippincott Williams & Wilkins)
Published: 2002
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14. Evaluation of the risk factors associated with lipodystrophy development in a cohort of HIV-positive patients.

Author: Seminari E, Tinelli C, Minoli L, Sacchi P, Filice G, Zocchetti C, Meneghetti G, Bruno R, and Maserati R
Subjects: Adolescent, Adult, Age Factors, Aged, Anti-HIV Agents administration & dosage, Anti-HIV Agents adverse effects, Anti-HIV Agents therapeutic use, CD4 Lymphocyte Count, Cohort Studies, Drug Administration Schedule, Female, HIV genetics, HIV immunology, HIV isolation & purification, HIV Infections drug therapy, HIV Infections immunology, HIV Infections virology, Humans, Logistic Models, Male, Middle Aged, Prevalence, RNA, Viral blood, Risk Factors, HIV Infections complications, HIV-Associated Lipodystrophy Syndrome complications, HIV-Associated Lipodystrophy Syndrome etiology
Abstract: The prevalence of lipodystrophy in an HIV-infected population and the risk factors associated with body shape changes were analysed in this study. Five hundred and four subjects were included. Among these, 201 (39.9%) had features of lipodystrophy syndrome (cases); 303 (60.1%) constituted the control group. Compared with the control group, the lipodystrophy subjects were different in age (P = 0.01); duration of antiretroviral therapy (P < 0.001); length of exposure to nucleoside reverse transcriptase inhibitors (NRTIs) (P < 0.001) and to protease inhibitors (P < 0.001); nadir of CD4 cell count (P < 0.001); and value of plasma HIV-RNA before antiretroviral therapy (P = 0.008). In a multivariate analysis, length of therapy and a nadir CD4 cell count below 250 cell/microl were associated with an increased risk of lipodystrophy. Among patients with lipodystrophy, isolated fat loss was observed in 46 (23%); isolated fat accumulation in 40 (20%); mixed (loss and accumulation) syndrome in 50 (25%); and isolated metabolic changes in 65 (32%). Subjects with morphological alterations displayed a greater cumulative time of exposure to NRTIs and to protease inhibitors than patients with isolated metabolic alterations. Patients with lipoatrophy had had a greater exposure to stavudine.
Published: 2002

15. Increased erythrocyte glutathione peroxidase activity and serum tumor necrosis factor-alpha in HIV-infected patients: relationship to on-going prothrombotic state.

Author: Trotti R, Rondanelli M, Anesi A, Gabanti E, Brustia R, and Minoli L
Subjects: Adult, Blood Proteins metabolism, Case-Control Studies, Erythrocytes enzymology, Female, HIV Infections etiology, Humans, Male, Oxidative Stress, Thrombophilia blood, Thrombophilia virology, Glutathione Peroxidase metabolism, HIV Infections blood, Tumor Necrosis Factor-alpha metabolism
Abstract: A condition of oxidative stress, due to perturbation of oxidant/antioxidant balance, has been suggested to play a role not only in the pathogenesis of human immunodeficiency virus (HIV) infection, but also in the promotion of a thrombophilic condition. Because various hemostatic dysfunctions usually considered as risk factors for thrombotic events were reported in HIV infection, this study was undertaken to investigate whether the oxidative phenomenon could promote a prothrombotic state in such condition. Erythrocyte glutathione peroxidase (GSH-Px), the major free-radical scavenger enzyme, and serum tumor necrosis factor-alpha (TNF-alpha) were evaluated in 33 consecutive HIV-infected out-patients and 35 matched HIV-negative healthy controls at a distance of any acute episode. Thrombin generation was explored by measuring the plasma levels of prothrombin fragment 1 + 2 (F1 + 2), whereas fibrin degradation products (D-dimer) and plasminogen activator inhibitor (PAI-1) activity were evaluated as indices of plasmin activity and fibrinolytic derangement. The anticoagulant pathway was investigated by measuring the plasma levels of antithrombin and protein C. Erythrocyte GSH-Px activity and serum TNF-alpha were significantly higher in HIV-infected patients when compared to controls. F1 + 2, D-dimer, and PAI-1 activity were increased in HIV-infected patients by comparison with controls. Normal antithrombin, but decreased protein C, was instead detected in HIV-infected patients. In the latter patients, serum TNF-alpha negatively correlated with both erythrocyte GSH-Px activity and plasma D-dimer. On the other hand, a positive correlation was shown between F1 + 2 and D-dimer and between D-dimer and GSH-Px activity. Furthermore, a trend toward increasing levels of GSH-Px with increasing PAI-1 activity was reported. These findings suggest a relationship between erythrocyte oxidative stress and the hypercoagulable condition during HIV infection.
Published: 2002
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16. Insulin-like growth factor I (IGF-I) and IGF-binding protein 3 response to growth hormone is impaired in HIV-infected children.

Author: Rondanelli M, Caselli D, Aricò M, Maccabruni A, Magnani B, Bacchella L, De Stefano A, Maghnie M, Solerte SB, and Minoli L
Subjects: Child, Cohort Studies, Fasting, Female, Health Status, Human Growth Hormone administration & dosage, Human Growth Hormone blood, Humans, Injections, Subcutaneous, Insulin-Like Growth Factor Binding Protein 3 metabolism, Male, Time Factors, HIV Infections blood, Human Growth Hormone pharmacology, Insulin-Like Growth Factor Binding Protein 3 blood, Insulin-Like Growth Factor I analysis
Abstract: To better characterize the somatotropic axis in HIV-infected children the circadian rhythm of growth hormone (GH), and basal and stimulated (by an insulin-like growth factor I [IGF-I] generation test) plasma levels of IGF-I and insulin-like growth factor-binding protein 3 (IGFBP-3), were evaluated in 16 children (9 boys and 7 girls; age range, 7-11 years) with HIV infection. All patients were free from active opportunistic infection or liver disease at the time of the study. Sixteen age- and sex-matched healthy children (10 boys and 6 girls; age range, 7-11 years) served as control subjects. GH rhythmometric data were analyzed by single and population mean cosinor analysis. As regards the IGF-I generation test, biosynthetic human GH (hGH, 0.1 IU/kg, 0.033 mg/kg) was administered subcutaneously for 4 days and blood samples were taken from fasting subjects at baseline and on the morning after the last GH injection for measurement of IGF-I and IGFBP-3. Plasma GH levels fell within normal limits in the HIV-seropositive patients and were similar to those of healthy children (1.31 +/- 1.18 vs. 1.57 +/- 1.16 microg/liter, respectively; mean +/- SD). The population mean cosinor analysis shows that the GH circadian rhythm reached statistical significance both in the HIV-seropositive children and in the control group. Despite this, the IGF-I and IGFBP-3 levels were significantly lower in HIV-infected children than in the control group (75.6 +/- 57.2 vs. 233.3 +/- 52.5 ng/ml, p < 0.001 and 2.09 +/- 0.17 vs. 3.89 +/- 0.24 mg/liter, p < 0.01, respectively; mean +/- SD); moreover, the response of IGF-I and IGFBP-3 to the IGF-I generation test was significantly lower in HIV-infected children than in the control group (86.3 +/- 55.8 vs. 257.5 +/- 53.4 ng/ml, p < 0.001 and 3.14 +/- 0.43 mg/liter, p < 0.01, respectively; mean +/- SD). It appears that circadian GH secretion is normal in children with HIV infection, but the response to exogenous GH with regard to IGF-I and IGFBP-3 production is impaired, indicating a degree of GH insensitivity in such children.
Published: 2002
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17. Plasma viral load concentrations in women and men from different exposure categories and with known duration of HIV infection. I.CO.N.A. Study Group.

Author: Rezza G, Lepri AC, d'Arminio Monforte A, Pezzotti P, Castelli F, Dianzani F, Lazzarin A, De Luca A, Arlotti M, Leoncini F, Manconi PE, Rizzardini G, Minoli L, Poggio A, Ippolito G, Phillips AN, and Moroni M
Subjects: Adolescent, Adult, Analysis of Variance, CD4 Lymphocyte Count, Cohort Studies, Cross-Sectional Studies, Female, HIV genetics, HIV Infections immunology, HIV Seropositivity immunology, HIV Seropositivity virology, Heterosexuality, Humans, Italy, Male, Middle Aged, RNA, Viral analysis, Regression Analysis, Reverse Transcriptase Polymerase Chain Reaction, Sex Factors, Substance Abuse, Intravenous, HIV isolation & purification, HIV Infections virology, Viral Load
Abstract: Context: According to recent studies, women have lower plasma HIV RNA concentrations than men. However, these studies did not take into account the duration of HIV infection., Objectives: To analyze the relationship between viral load and gender among individuals with known date of seroconversion., Setting: Sixty infectious disease clinics in Italy., Design: Cross-sectional analysis of data collected at enrollment in a cohort study., Participants: Injecting drug users and heterosexual contacts naive to antiretroviral therapy at enrollment (245 men; 170 women)., Main Outcome Measures: Plasma HIV RNA concentrations, measured using quantitative reverse transcriptase-polymerase chain reaction (RT-PCR) or signal amplification b-DNA assays before antiretroviral therapy., Results: Plasma HIV RNA concentrations were similar by age and exposure category (p =.80 and p =.39, respectively). Median viral load among women was roughly half that of men (p =.002). The association between viral load and gender remained significant after fitting a two-way analysis of variance (p =.03) and after adjusting for CD4 count, modality of HIV transmission, and age at enrollment in a regression model. Viral load was 0.27 log10 copies/ml (95% confidence interval, 0.05-0.40; p =.01) lower in women (i.e., 50% lower in the raw scale)., Conclusions: Plasma HIV RNA concentrations were found to be lower among women, even when considering the duration of HIV infection. Compared with men, it is possible women should be given highly aggressive antiretroviral therapy at lower HIV-RNA concentrations.
Published: 2000
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18. CD38/CD8 expression and HAART failure.

Author: Caselli D, Comolli G, Maccabruni A, Klersy C, and Minoli L
Subjects: ADP-ribosyl Cyclase, ADP-ribosyl Cyclase 1, Adolescent, Child, Child, Preschool, Female, Humans, Infant, Infant, Newborn, Male, Membrane Glycoproteins, Treatment Failure, Anti-HIV Agents therapeutic use, Antigens, CD, Antigens, Differentiation biosynthesis, CD8 Antigens biosynthesis, HIV Infections drug therapy, HIV Infections immunology, NAD+ Nucleosidase biosynthesis
Published: 1999
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19. Cyclosporine for rectoperineal fistula in a human immunodeficiency virus-infected child.

Author: Caselli D, Maccabruni A, Beluffi G, and Minoli L
Subjects: Adolescent, Antiviral Agents therapeutic use, Burkitt Lymphoma complications, Child, Fistula complications, HIV Infections drug therapy, Humans, Male, Rectal Fistula complications, Cyclosporine therapeutic use, Fistula drug therapy, HIV Infections complications, HIV Infections congenital, Perineum, Rectal Fistula drug therapy
Published: 1999
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20. Involvement of hormonal circadian secretion in the growth of HIV-infected children.

Author: Rondanelli M, Caselli D, Maccabruni A, Maghnie M, Bacchella L, DeStefano A, Solerte SB, Minoli L, and Ferrari E
Subjects: Adolescent, Adrenocorticotropic Hormone metabolism, Child, Child, Preschool, Female, Human Growth Hormone metabolism, Humans, Hydrocortisone metabolism, Insulin-Like Growth Factor I metabolism, Male, Thyrotropin metabolism, Circadian Rhythm physiology, Growth physiology, HIV Infections physiopathology, Hormones metabolism
Abstract: Objective: To evaluate the circadian secretion of hormones involved in the regulation of growth in childhood, namely growth hormone, insulin-like growth factor (IGF)-I, cortisol, adrenocorticotropin hormone (ACTH), and thyroid-stimulating hormone (TSH) in HIV-infected children., Design: The circadian secretory pattern of growth hormone, IGF-I, cortisol, ACTH and TSH was evaluated in 14 HIV-infected children; 13 healthy age- and sex-matched children were chosen as controls., Methods: Sampling was performed every 4 h from 0400 h to 2000 h and every 2 h from 2000 h to 0400 h. Rhythmometric data were analysed by single and population mean cosinor methods and by analysis of variance., Results: A statistically significant circadian rhythm for growth hormone, IGF-I and cortisol was detectable in HIV-seropositive children, but the mean basal IGF-I levels were below the normal range for age in 12 patients. A statistically significant circadian rhythm was not detectable for ACTH or TSH., Conclusion: These results show that there is a loss of the physiological regulation of growth hormone-IGF-I axis and a modification of 24 h TSH profile in our HIV-infected children. These abnormalities might be involved in the altered growth mechanism leading to the failure to thrive that is a peculiar feature of HIV-infected children.
Published: 1998
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21. Therapeutic advantage of hydroxyurea and didanosine combination therapy in patients previously treated with zidovudine.

Author: Foli A, Maserati R, Minoli L, Wainberg MA, Gallo RC, Lisziewicz J, and Lori F
Subjects: Drug Therapy, Combination, HIV Infections blood, HIV Infections virology, Humans, Retrospective Studies, Anti-HIV Agents therapeutic use, Didanosine therapeutic use, HIV Infections drug therapy, Hydroxyurea therapeutic use, Reverse Transcriptase Inhibitors therapeutic use, Zidovudine therapeutic use
Published: 1998

22. Circadian secretory pattern of growth hormone, insulin-like growth factor type I, cortisol, adrenocorticotropic hormone, thyroid-stimulating hormone, and prolactin during HIV infection.

Author: Rondanelli M, Solerte SB, Fioravanti M, Scevola D, Locatelli M, Minoli L, and Ferrari E
Subjects: Adult, Female, HIV Infections virology, HIV Seropositivity blood, HIV Seropositivity virology, Humans, Male, Adrenocorticotropic Hormone blood, Circadian Rhythm physiology, Growth Hormone blood, HIV Infections blood, Hydrocortisone blood, Insulin-Like Growth Factor I metabolism, Prolactin blood, Thyrotropin blood
Abstract: The circadian rhythms of plasma growth hormone (GH), insulin-like growth factor type I (IGF-I), cortisol, adrenocorticotropic hormone (ACTH), thyroid-stimulating hormone (TSH), and prolactin (PRL) were evaluated in 13 HIV-seropositive patients (8 males and 5 females; mean age [+/-SD], 30 +/- 5 years), classified as CDC C2. Sixteen clinically healthy subjects (9 males and 7 females; mean age [+/-SD], 32 +/- 8 years) were chosen as control group. Samples were taken every 4 hr from 04:00 to 20:00 and every 2 hr from 20:00 to 04:00. Plasma GH was evaluated by IRMA procedure, plasma IGF-I by RIA (after separation of soluble IGF-I from IGF-I-binding proteins, using acid-ethanol extraction), plasma cortisol by a solid-phase RIA, plasma ACTH by double-antibody RIA, and serum TSH and serum PRL by a solid-phase two-site fluoroimmunometric assay. Rhythmometric data were analyzed by single and population mean cosinor analysis; the comparison of the parameters of the rhythm between patients and controls was carried out by the mesor test and the amplitude-acrophase Hotelling test. Alterations of the circadian pattern of GH, IGF-I, cortisol, ACTH, TSH, and PRL were demonstrated in HIV-seropositive patients. In fact, the circadian profiles of these hormones were clearly flattened and no statistically significant 24-hr rhythm was detectable (with the exception of cortisol). These results are consistent with the hypothesis that alterations of the circadian temporal structure may already be present in HIV-seropositive patients without wasting and infectious complications.
Published: 1997
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23. Flow cytometric evaluation of CD38, CD45 RO and CD45 RA in HIV-infected children.

Author: Caselli D, Comolli G, Maccabruni A, Campisi D, Klersy C, and Minoli L
Subjects: ADP-ribosyl Cyclase, ADP-ribosyl Cyclase 1, Adolescent, Antigens, CD metabolism, Child, Child, Preschool, Female, Humans, Immunophenotyping, Infant, Infant, Newborn, Male, Membrane Glycoproteins, Antigens, Differentiation metabolism, HIV Infections immunology, Leukocyte Common Antigens metabolism, NAD+ Nucleosidase metabolism
Published: 1997

24. Hydroxyurea and didanosine is a more potent combination than hydroxyurea and zidovudine.

Author: Foli A, Lori F, Maserati R, Tinelli C, Minoli L, and Lisziewicz J
Subjects: Adult, CD4 Lymphocyte Count, Didanosine adverse effects, Drug Therapy, Combination, Female, HIV Infections immunology, HIV Infections virology, Humans, Hydroxyurea adverse effects, Male, Middle Aged, Zidovudine adverse effects, Anti-HIV Agents administration & dosage, Didanosine administration & dosage, HIV Infections drug therapy, Hydroxyurea administration & dosage, Zidovudine administration & dosage
Abstract: The in vitro and in vivo antiviral activity of hydroxyurea in combination with either zidovudine or didanosine was evaluated in primary human peripheral mononuclear cells and in a cohort of 29 asymptomatic patients infected with HIV. In vitro, hydroxyurea alone did not significantly affect HIV replication, whereas the combination of hydroxyurea with didanosine was more effective than the combination of hydroxyurea with zidovudine. Our clinical results confirmed these studies. Patients were randomly assigned to five arms (zidovudine, hydroxyurea or didanosine monotherapy, or hydroxyurea in combination with either zidovudine or didanosine) to evaluate preliminary safety and efficacy. Bone-marrow toxicity occurred in two patients treated with zidovudine plus hydroxyurea, alopecia was reported in one patient treated with hydroxyurea monotherapy, and there were no toxic effects recorded in the remaining three groups. Plasma viraemia was not influenced by hydroxyurea monotherapy, and the hydroxyurea-zidovudine combination did not give any advantage over either zidovudine or didanosine monotherapy (0.3-0.5 log decrease in plasma viraemia). In contrast, a 1.1 log drop in plasma viraemia was observed in patients treated with hydroxyurea plus didanosine, this reduction was sustained throughout the 24-week course of the treatment. Combination therapy with hydroxyurea and didanosine exhibited statistically significant improvements compared with the other therapeutic approaches. Although further clinical trials are required, these results suggest that hydroxyurea in combination with didanosine might be an effective and well-tolerated, simple and affordable, treatment for HIV infection.
Published: 1997

25. Longitudinal neuropsychological evaluation of HIV-infected intravenous drug users.

Author: Bono G, Mauri M, Sinforiani E, Barbarini G, Minoli L, and Fea M
Subjects: AIDS Dementia Complex psychology, Adult, CD4 Lymphocyte Count, Female, Follow-Up Studies, HIV Infections diagnosis, HIV Infections psychology, Humans, Longitudinal Studies, Male, Psychometrics, AIDS Dementia Complex diagnosis, HIV Infections transmission, Neuropsychological Tests statistics & numerical data, Substance Abuse, Intravenous complications
Abstract: The present study aimed to describe the cognitive status of a group of HIV-positive asymptomatic intravenous drug users (IVDU) and changes which occurred over a 12-month follow-up period. Forty-two HIV positive IVDU were selected and matched for age, sex, educational level and pattern of drug abuse with 39 seronegative IVDU controls. Baseline and follow-up evaluation included neuropsychological tests exploring attention, language, memory, logic and visuomotor abilities, biological markers and clinical parameters. About one-third of both seropositive and seronegative subjects showed at baseline slight cognitive deficits, which did not change during the follow-up period.
Published: 1996
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26. [Clinical aspects of immunoneuroendocrine alterations in HIV infection].

Author: Rondanelli M and Minoli L
Subjects: HIV Infections immunology, Hormones physiology, Humans, Endocrine Glands physiopathology, HIV Infections physiopathology, Immune System physiopathology, Nervous System physiopathology
Abstract: A number of studies confirm that any human tissue can be targeted by HIV, and also the endocrine system is involved during HIV infection. No endocrine adenus is saved by the assault of the opportunistic pathogens that overrun the organism unprotected due to the severe and progressive immune deficits induced by the HIV. As a consequence clinical, but often subclinical alterations can be detected that underline the close relationship among the systems of body adaptation to the environment (immune, endocrine, and nervous). Indeed these alterations can be viewed as an immunoneuroendocrine pathology. AIDS is a paradigmatic syndrome for the variety of immune dysfunctions, and also presents endocrine and neurological dysfunctions, which allow to better understand the connections among these systems, and the interactions of HIV with the immunoneuroendocrine dynamics.
Published: 1995

27. Acute Guillain-Barré syndrome associated with asymptomatic HIV infection.

Author: Franciotta DM, Brustia R, Minoli L, Bono G, Ceroni M, Parisi A, and Melzi d'Eril G
Subjects: Adult, Humans, Male, Plasma Exchange, Polyradiculoneuropathy cerebrospinal fluid, Polyradiculoneuropathy therapy, HIV Infections complications, Polyradiculoneuropathy etiology
Abstract: A 25-year-old male drug addict presented with a rapidly progressive ascending tetraplegia, requiring assisted ventilation. One month earlier he had fever (40 degrees C) and asthenia. Cerebrospinal fluid (CSF) examination showed elevated albumin level and albuminocytologic dissociation. HIV testing was positive in both serum and CSF. Plasma exchange therapy only partially improved the symptomatology. After five months the patient remained with a moderate tetraparesis. Differences between this and other cases of Guillain-Barré syndrome in HIV-seropositive patients reported in the literature are discussed.
Published: 1992

28. Cognitive abnormalities and disease progression in a selected population of asymptomatic HIV-positive subjects.

Author: Sinforiani E, Mauri M, Bono G, Muratori S, Alessi E, and Minoli L
Subjects: Adult, Analysis of Variance, Cognition Disorders immunology, Cognition Disorders psychology, HIV Infections complications, HIV Infections immunology, HIV Seropositivity, Humans, Longitudinal Studies, Male, Middle Aged, Neuropsychological Tests, Risk Factors, Cognition Disorders complications, HIV Infections psychology, Memory Disorders complications
Abstract: A selected population of 41 homosexual/bisexual asymptomatic HIV-positive subjects were administered neurophysiological tests to assess language, memory, attention, logic faculties and visuo-motor functions. HIV-positive subjects differed from individually matched control subjects only in certain measures of verbal memory. Longitudinal evaluation performed after 1.5 years, however, did not indicate any further development of this mild amnesic deficit. Despite the small number studied in our sample, there seems to be a trend for older subjects to be at greater risk of developing AIDS and cognitive abnormalities than younger subjects, while differences in immunological status play a significant role in disease progression.
Published: 1991
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29. Hepatotoxicity Development During Antiretroviral Therapy Containing Protease Inhibitors in Patients With HIV

Author: Aceti, A, Pasquazzi, C, Zechini, B, De Bac, C, Liverhaart, Group, Cargnel, A, Giorgi, R, Carosi, G, Torti, C, Chiodo, F, Giuliani, R, Concia, Ercole, Cainelli, F, Ghinelli, F, Roda, R, Mazzotta, F, Pierotti, L, Milazzo, F, Fagion, I, Minoli, L, Rizzi, L, Mura, Ms, Sotgiu, G, Ortona, L, Di Gianbenedetto, S, Pastore, G, Cavaliere, R, Piazza, M, Maddaloni, L, Sagnelli, E, Nacca, C, Scalise, G, Del Prete MS, Vullo, V, and Santopadre, P.
Subjects: Adult, Male, hepatotoxicity, Time Factors, Hepatitis C virus, protease inhibitors, HIV Infections, medicine.disease_cause, Antiviral Agents, Risk Factors, Prevalence, medicine, Humans, Pharmacology (medical), Protease inhibitor (pharmacology), Retrospective Studies, Hepatitis, Ritonavir, business.industry, HIV, Alanine Transaminase, Bilirubin, HIV Protease Inhibitors, Viral Load, Hepatitis B, medicine.disease, Hepatitis C, ART, hepatotoxicity, hepatitis C or B virus, HIV, protease inhibitors, Infectious Diseases, Italy, Chemical and Drug Induced Liver Injury, Chronic, Immunology, Coinfection, Regression Analysis, Female, hepatitis C or B virus, business, Viral hepatitis, Viral load, ART, medicine.drug
Abstract: To evaluate the occurrence of hepatotoxicity in patients during antiretroviral therapy (ART) that contains protease inhibitors and the role of hepatitis viruses in its development, we performed a retrospective study including 1325 HIV-infected patients treated with ART for at least 6 months. Presence or absence of hepatitis viruses, alanine aminotransferase (ALT), total bilirubin, CD4 cell count, and plasma HIV RNA levels were evaluated. Hepatotoxicity developed in a few study subjects without coinfection, whereas it was significantly higher in coinfected patients. Univariate logistic regression analysis showed that viral hepatitis coinfections are independent risk factors for hepatotoxicity. After 6 months of treatment, ritonavir was associated with higher rates of severe hepatotoxicity in the coinfected group; in fact, ritonavir seems to be the most strongly hepatotoxic agent among coinfected patients. After 12 months of therapy, hepatotoxicity occurred more frequently in patients with hepatitis C virus who did not respond to antiretroviral therapy (ART), whereas patients who did respond to ART showed decreased ALT levels. Hepatotoxicity is not exclusively an effect of drug toxicity, and the presence of hepatitis coinfection is an independent risk factor. Moreover, chronic hepatotoxicity mainly occurs in patients who did not respond to therapy. Conversely, patients who did respond to ART seemed to show improvement of chronic liver infection.
Published: 2002

30. Human immunodeficiency virus-related cancer in children: incidence and treatment outcome--report of the Italian Register

Author: Caselli D, Klersy C, de Martino M, Gabiano C, Galli L, Tovo PA, Aricò M, Giaquinto C. Giacomet V, Castelli Gattinara G, Livadiotti S, Minoli L, Maccabruni A, Fundarò C, Osimani P, De maria A, Rossi G, Dessì C, Viganò A, Plebani A, Riva C, De mattia D, Salvatore C, Mazza A., GUARINO, ALFREDO, Caselli, D, Klersy, C, de Martino, M, Gabiano, C, Galli, L, Tovo, Pa, Aricò, M, Giaquinto C., Giacomet V, Castelli Gattinara, G, Livadiotti, S, Minoli, L, Maccabruni, A, Fundarò, C, Osimani, P, Guarino, Alfredo, De maria, A, Rossi, G, Dessì, C, Viganò, A, Plebani, A, Riva, C, De mattia, D, Salvatore, C, and Mazza, A.
Subjects: Male, Cancer Research, medicine.medical_specialty, Pediatrics, Adolescent, HIV Infections, Acquired immunodeficiency syndrome (AIDS), Pregnancy, Neoplasms, Epidemiology, medicine, Humans, Prospective Studies, Registries, Risk factor, Sida, Child, Lymphoma, AIDS-Related, Acquired Immunodeficiency Syndrome, Perinatal Exposure, biology, business.industry, Incidence (epidemiology), Incidence, Lymphoma, Non-Hodgkin, Infant, Newborn, Infant, biology.organism_classification, medicine.disease, Infectious Disease Transmission, Vertical, Surgery, Treatment Outcome, Oncology, El Niño, Italy, Child, Preschool, Female, Viral disease, business
Abstract: PURPOSE: To outline the incidence, presenting features, treatment response, and outcome of human immunodeficiency virus (HIV)–associated malignancies in infancy and childhood, together with the estimated risk of HIV-associated cancer in children born to mothers infected with HIV. PATIENTS AND METHODS: The Italian Register for HIV Infection in Children collected data by specific registration and follow-up forms. By March 1999, 5,060 children were recruited, including 4,889 with perinatal exposure to HIV-1. Overall, 1,331 infected children were enrolled onto the Register and classified according to current Centers for Disease Control criteria; of them, 1,163 were vertically infected (24% of those with perinatal exposure). Of these 1,163, 569 (49%) were considered to have been prospectively followed-up since they had been registered at birth or within the first 3 months of age. RESULTS: Of the 1,331 children observed for a median time of 6.5 years, 35 developed 36 malignancies, four of which occurred in patients with blood-borne risk. For the 1,163 vertically infected children, the cumulative number of years of observation was 7,178 child-years and the cumulative incidence of HIV-associated tumors was 4.18 per 1,000 children/yr (95% confidence interval [CI], 2.92 to 5.98). When only the 569 vertically infected children prospectively followed up since birth were considered, the cumulative number of years of observation was 2,803 child-years. In this group, 10 tumors were observed, with a cumulative incidence of HIV-associated tumors of 3.57 per 1,000 children per year (95% CI, 1.92 to 6.63). CONCLUSION: The risk of cancer was significantly higher but not restricted to symptomatic and/or immune-compromised children. Cancer-directed treatment should be given promptly to these patients, who have a fair chance to survive their tumor in view of potential highly aggressive antiretroviral therapy–associated improvement in survival and quality of life.
Published: 2000

31. Replication capacity in relation to immunologic and virologic outcomes in HIV-1-infected treatment-naive subjects

Author: Skowron, G, Spritzler, Jg, Weidler, J, Robbins, Gk, Johnson, Va, Chan, Es, Asmuth, Dm, Gandhi, Rt, Lie, Y, Bates, M, Pollard, Rb, NIH/NIAID ACTG 384 Protocol Team, Monogram, Biosciences, Vella, S, Chiesi, C, Arcieri, R, Pirillo, Mf, Galluzzo, Cm, Pia Germinario EA, Amici, R, Marzi, M, Nobile, A, Di Nallo, R, Polizzi, C, Coronado, O, Fasulo, G, Carosi, Giampiero, Castelli, Francesco, Di Pietro, M, Vichi Ospedale, F, Sterrantino, G, Ambu, S, Cargnel, A, Meraviglia, P, Niero, F, Capetti, A, d'Arminio Monforte, A, Sollima, S, Balotta, C, Delia, S, Ciardi, M, Soranzo, Ml, Macor, A, D'Ettorre, G, Forcina, G, Bassetti, D, Di Biagio, A, Minoli, L, Maserati, R, Ghinelli, F, Sighinolfi, L, Riva, A, Scalise, G, Santoro, D, Rinaldi, E, Chiodo, F, Borderi, M, Guaraldi, G, Esposito, R, Ferrari, C, Pasetti, G, Abrescia, N, Busto, A, Chirianni, A, Gargiulo, M, Izzo, Cm, Sbreglia, C, Alberici, F, Sacchini, D, Magnani, G, and Zoboli, G.
Subjects: Adult, Male, medicine.medical_specialty, Human immunodeficiency virus (HIV), HIV Infections, medicine.disease_cause, Virus Replication, Gastroenterology, Virus, Article, Pharmacotherapy, Internal medicine, Immunopathology, medicine, Humans, Pharmacology (medical), Sida, Aged, biology, Middle Aged, Viral Load, biology.organism_classification, CD4 Lymphocyte Count, Infectious Diseases, Lentivirus, Immunology, HIV-1, Female, Viral disease, Viral load
Abstract: Objectives: To evaluate the association between baseline (BL) replication capacity (RC) (RC BL ) and immunologic/virologic parameters (at BL and after 48 weeks on therapy) in HIV-1-infected subjects initiating antiretroviral therapy. Methods: RC BL was determined using a modified Monogram PhenoSense HIV drug susceptibility assay on plasma HIV-1 from 321 treatment-naive subjects from AIDS Clinical Trials Group 384. Univariate and multivariable analyses were performed to determine the association of RC BL with BL and on-therapy virologic and immunologic outcomes. Results: Higher RC BL was associated with lower baseline CD4 (CD4 BL ) (r = -0.23, P < 0.0001), higher baseline HIV-1 RNA (r = 0.25, P < 0.0001), higher CD4 BL activation percent (r = 0.23, P < 0.0001), and lower CD4 BL memory count (r = -0.21, P = 0.0002). In a multivariable model, week 48 CD4 increase (ΔCD4 48 ) was associated with lower CD4 BL memory count and higher CD4 BL -naive percent (P = 0.004, P = 0.015, respectively). The interaction between CD4 BL and RC BL was significant (P = 0.018), with a positive association between RC BL and ΔCD4 48 in subjects with higher CD4 BL and a negative association at lower absCD4 BL . Conclusions: At baseline, higher RC was significantly associated with higher HIV-1 RNA, higher CD4 cell activation, lower CD4 cell count, and lower CD4 memory cell count. These factors may interact, directly or indirectly, to modify the extent to which CD4 recovery occurs in patients starting antiretroviral therapy at different CD4 BL counts.
Published: 2009

32. Importance of baseline prognostic factors with increasing time since initiation of highly active antiretroviral therapy: collaborative analysis of cohorts of HIV-1-infected patients

Author: Sterne, Jonathan A. C., May, Margaret, Sabin, Caroline, Phillips, Andrew, Costagliola, Dominique, Chêne, Geneviève, Justice, Amy C., De Wolf, Frank, Hogg, Robert, Battegay, Manuel, Monforte, Antonella D'Arminio, Gerdtkenheuer, Fa, Staszewski, Schlomo, Gill, John, Egger, Matthias, Casabona, Jordi, Dabis, Francxois, Kitahata, Mari, Leport, Catherine, Lundgren, Jens, Reiss, Peter, Saag, Michael, Weller, Ian, Beckthold, Brenda, Yip, Benita, Dauer, Brenda, Fusco, Jenifer, Lanoy, Emilie, Rickenbach, Martin, Lavignolle, Valerie, Van Sighem, Ard, Pereira, Edwige, Pezzotti, Patrizio, Schmeisser, Norbert, Billaud, E., Boué, F., Costagliola, D., Duval, X., Duvivier, C., Enel, P., Fournier, S., Gasnault, J., Gaud, C., Gilquin, J., Grabar, S., Khuong, M. A., Lang, J. M., Mary Krause, M., Matheron, S., Meyohas, M. C., Pialoux, G., Poizot Martin, I., Pradier, C., Rouveix, E., Salmon Ceron, D., Sobel, A., Tattevin, P., Tissot Dupont, H., Yasdanpanah, Y., Aronica, E, Tirard Fleury, V., Tortay, I., Abgrall, S., Guiguet, M., Lanoy, E., Leneman, H., Lièvre, L., Potard, V., Saidi, S., Vildé, J. L., Leport, C., Yeni, P., Bouvet, E., Gaudebout, C., Crickx, B., Picard Dahan, C., Weiss, L., Tisne Dessus, D., Sicard, D., Salmon, D., Auperin, I., Viard, J. P., Roudière, L., Fior, R., Delfraissy, J. F., Goujard, C., Lesprit, P. h., Jung, C., Meynard, J. L., Picard, O., Desplanque, N., Cadranel, J., Mayaud, C., Rozenbaum, W., Bricaire, F., Katlama, C., Herson, S., Simon, A., Decazes, J. M., Molina, J. M., Clauvel, J. P., Gerard, L., Sellier, P., Diemer, M., Dupont, C., Berthé, H., Saïag, P., Mortier, E., Chandemerle, C., De Truchis, P., Bentata, M., Honoré, P., Tassi, S., Jeantils, V., Mechali, D., Taverne, B., Laurichesse, H., Gourdon, F., Lucht, F., Fresard, A., Faller, J. P., Eglinger, P., Bazin, C., Verdon, R., Peyramond, D., Boibieux, A., Touraine, J. L., Livrozet, J. M., Trepo, C., Cotte, L., Ravaux, I., Delmont, J. P., Moreau, J., Gastaut, J. A., Soubeyrand, J., Retornaz, F., Blanc, P. A., Allegre, T., Galinier, A., Ruiz, J. M., Lepeu, G., Granet Brunello, P., Pelissier, L., Esterni, J. P., Nezri, M., Cohen Valensi, R., Laffeuillade, A., Chadapaud, S., Reynes, J., May, T., Rabaud, C., Raffi, F., Pugliese, P., Michelet, C., Arvieux, C., Caron, F., Borsa Lebas, F., Rey, D., Fraisse, P., Massip, P., Cuzin, L., Arlet Suau, E., Thiercelin Legrand, M. F., Sobesky, M., Pradinaud, R., Contant, M., Montroni, M., Scalise, G., Braschi, M. C., Riva, A., Tirelli, U., Cinelli, R., Pastore, G., Ladisa, N., Minafra, G., Suter, F., Arici, C., Pristera, R., Chiodo, F., Colangeli, V., Fiorini, C., Coronado, O., Carosi, G., Cadeo, G. P., Torti, C., Minardi, C., Bertelli, D., Rizzardini, G., Melzi, S., Manconi, P. E., Piano, P., Cosco, L., Scerbo, A., Vecchiet, J., D'Alessandro, M., Santoro, D., Pusterla, L., Carnevale, G., Citterio, P., Viganò, P., Mena, M., Ghinelli, F., Sighinolfi, L., Leoncini, F., Mazzotta, F., Pozzi, M., Lo Caputo, S., Vullo, Vincenzo, Lichtner, Miriam, Angarano, G., Grisorio, B., Saracino, A., Ferrara, S., Grima, P., Tundo, P., Pagano, G., Cassola, G., Alessandrini, A., Piscopo, R., Toti, M., Chigiotti, S., Soscia, F., Tacconi, L., Orani, A., Perini, P., Scasso, A., Vincenti, A., Chiodera, F., Castelli, P., Scalzini, A., Palvarini, L., Moroni, M., Lazzarin, A., Cargnel, A., Vigevani, G. M., Caggese, L., d'Arminio Monforte, A., Repetto, D., Galli, A., Merli, S., Pastecchia, C., Moioli, M. C., Esposito, R., Mussini, C., Abrescia, N., Chirianni, A., Izzo, C. M., Piazza, M., De Marco, M., Viglietti, R., Manzillo, E., Nappa, S., Antonucci, G., Iacomi, F., Narciso, P., Zaccarelli, M., Colomba, A., Abbadessa, V., Prestileo, T., Mancuso, S., Ferrari, C., Pizzaferri, P., Filice, G., Minoli, L., Bruno, R., Novati, S., Baldelli, F., Tinca, M., Petrelli, E., Cioppi, A., Alberici, F., Ruggieri, A., Menichetti, F., Martinelli, C., De Stefano, C., La Gala, A., Ballardini, G., Rizzo, E., Magnani, G., Ursitti, M. A., Arlotti, M., Ortolani, P., Cauda, R., Dianzani, F., Ippolito, G., Antinori, A., D'Elia, S., Petrosillo, N., De Luca, A., Bacarelli, A., Acinapura, R., De Longis, P., Brandi, A., Trotta, M. P., Noto, P., Capobianchi, M. R., Carletti, F., Girardi, E., Pezzotti, P., Rezza, G., Mura, M. S., Mannazzu, M., Caramello, P., Di Perri, G., Soranzo, M. L., Orofino, G. C., Arnaudo, I., Bonasso, M., Grossi, P. A., Basilico, C., Poggio, A., Bottari, G., Raise, E., Ebo, F., De Lalla, F., Tositti, G., Resta, F., Loso, K., Cozzi Lepri, A., Johnson, A. M., Mercey, D., Phillips, A., Johnson, M. A., Mocroft, A., Murphy, M., Weber, J., Scullard, G., Fisher, M., Battegay, M., Bernasconi, E., Böni, J., Bucher, H., Bürgisser, P. h., Cattacin, S., Cavassini, M., Dubs, R., Egger, M., Elzi, L., Erb, P., Fantelli, K., Fischer, M., Flepp, M., Fontana, A., Francioli, P., Hirschel, B., Soravia Dunand, V., Furrer, H., Gorgievski, M., Günthard, H., Kaiser, L., Kind, C., Klimkait, T. h., Lauper, U., Ledergerber, B., Opravil, M., Paccaud, F., Pantaleo, G., Perrin, L., Piffaretti, J. C., Rickenbach, M., Rudin, C., Schmid, P., Schüpbach, J., Speck, R., Telenti, A., Trkola, A., Vernazza, P., Buy, E., Bronsveld, W., Hillebrand Haverkort, M. E., Reiss, P., Back, N. K. T., Bakker, M. E. G., Berkhout, B., Jurriaans, S., Cuijpers, T. h., Rietra, P. J. G. M., Roozendaal, K. J., Pauw, W., Van Zanten, A. P., Smits, P. H. M., Von Blomberg, B. M. E., Savelkoul, P., Danner, S. A., Van Agtmael, M. A., Claessen, F. A. P., Perenboom, R. 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W., Van Houte, D. P. F., Polee, M., Kroes, A. C. M., Claas, H. C. J., Kroon, F. P., Van Den, Broek, Van Dissel, J. T., Schippers, E. F., Bruggeman, C. A. M. V. A., Goossens, V. J., Schreij, G., Van De Geest, S., Verbon, A., Galama, J. M. D., Melchers, W. J. G., Poort, Y. A. G., Koopmans, P. P., Keuter, M., Post, F., Van Der Ven, A. J. A. M., Doornum, G. J. J., Niesters, M. G., Osterhaus, A. D. M. E., Schutten, M., Driessen, G., De Groot, R., Hartwig, N., Van Der Ende, M. E., Gyssens, I. C., Van Der Feltz, M., Den Hollander, J. G., De Marie, S., L. Nouwen, J., Rijnders, B. J. A., De Vries, T. E. M. S., Juttmann, J. R., Van De Heul, C., Van Kasteren, M. E. E., Boucher, C. A. B., Schuurman, R., Geelen, S. P. M., Wolfs, T. F. W., Schneider, M. M. E., Bonten, M. J. M., Borleffs, J. C. C., Ellerbroek, P. M., Hoepelman, I. M., Jaspers, C. A. J. J., Schouten, I., Schurink, C. A. M., Blok, W. L., Tanis, A. A., Groeneveld, P. H. P., Jansen, C. L., Hendriks, R., Veenendaal, D., Storm, H., Weel, J., Van Zeijl, J. H., Buiting, A. G. M., Swaans, C. A. M., Boel, E., Jansz, A. F., Losso, M., Duran, A., Vetter, N., Karpov, I., Vassilenko, A., Clumeck, N., Dewit, S., Poll, B., Colebunders, R., Machala, L., Rozsypal, H., Sedlacek, D., Gerstoft, J., Katzenstein, T., Hansen, A. B. E., Skinhøj, P., Nielsen, J., Lundgren, J., Benfield, T., Kirk, O., Pedersen, C., Zilmer, K., Girard, P. M., Saint Marc, T., Vanhems, P., Dabis, F., Dietrich, M., Manegold, C., Van Lunzen, J., Stellbrink, H. J., Staszewski, S., Bickel, M., Goebel, F. D., Fätkenheuer, G., Rockstroh, J., Schmidt, R., Kosmidis, J., Gargalianos, P., Sambatakou, H., Perdios, J., Panos, G., Filandras, A., Karabatsaki, E., Banhegyi, D., Mulcahy, F., Yust, I., Turner, D., Burke, M., Pollack, S., Hassoun, G., Sthoeger, Z., Maayan, S., Borghi, R., Cotugno, A. D., Gabbuti, A., Chiesi, A., Montesarchio, E., Finazzi, R., D'Arminio Monforte, A., Viksna, L., Chaplinskas, S., Hemmer, R., Staub, T., Bruun, J., Maeland, A., Ormaasen, V., Knysz, B., Gasiorowski, J., Horban, A., Prokopowicz, D., Wiercinska Drapalo, A., Boron Kaczmarska, A., Pynka, M., Beniowski, M., Mularska, E., Trocha, H., Antunes, F., Valadas, E., Mansinho, K., Matez, F., Duiculescu, D., Babes, Victor, Streinu Cercel, A., Vinogradova, E., Rakhmanova, A., Jevtovic, D., Mokráš, M., Staneková, D., González Lahoz, J., Sánchez Conde, M., García Benayas, T., Martin Carbonero, L., Soriano, V., Clotet, B., Jou, A., Conejero, J., Tural, C., Gatell, J. M., Miró, J. M., Blaxhult, A., Karlsson, A., Pehrson, P., Weber, R., Kravchenko, E., Chentsova, N., Barton, S., Brettle, R., Loveday, C., Antunes, Francisco, Blaxhult, Anders, Clumeck, Nathan, Gatell, Jose, Horban, Andrzej, Johnson, Anne, Katlama, Christine, Ledergerber, Bruno, Loveday, Clive, Vella, Stefano, Gjørup, I., Friis Moeller, N., Bannister, W., Mollerup, D., Podlevkareva, D., Holkmann Olsen, C., Kjær, J., Raffanti, Stephen, Dieterch, Douglas, Becker, Stephen, Scarsella, Anthony, Fusco, Gregory, Most, Bernard, Balu, Rukmini, Rana, Rashida, Beckerman, Robin, Ising, Theodore, Fusco, Jennifer, Irek, Renae, Johnson, Bernadette, Hirani, Ashwin, Edwinjesus, De, Pierone, Gerald, Lackey, Philip, Irek, Chip, Johnson, Alison, Burdick, John, Leon, Saul, Arch, Joseph, Helm, Eilke B., Carlebach, Amina, Axelller, Mu, Haberl, Annette, Nisius, Gabi, Lennemann, Tessa, Rottmann, Carsten, Wolf, Timo, Stephan, Christoph, Bickel, Markus, Manfredsch, Mo, Gute, Peter, Locher, Leo, Lutz, Thomas, Klauke, Stephan, Knecht, Gabi, Doerr, Hans W., Stu, Martinrmer, Von Hentig, Nils, Jennings, Beverly, Beylot, J., Chêne, G., Dupon, M., Longy Boursier, M., Pellegrin, J. L., Ragnaud, J. M., Salamon, R., Thiébaut, R., Lewden, C., Lawson Ayayi, S., Mercié, P., Moreau, J. F., Morlat, P., Bernard, N., Lacoste, D., Malvy, D., Neau, D., Blaizeau, M. J., Decoin, M., Delveaux, S., Hannapier, C., Labarrère, S., Lavignolle Aurillac, V., Uwamaliya Nziyumvira, B., Palmer, G., Touchard, D., Balestre, E., Alioum, A., Jacqmin Gadda, H., Bonarek, M., Bonnet, F., Coadou, B., Gellie, P., Nouts, C., Bocquentin, F., Dutronc, H., Lafarie, S., Aslan, A., Pistonne, T., Thibaut, P., Vatan, R., Chambon, D., De La Taille, C., Cazorla, C., Ocho, A., Viallard, J. F., Caubet, O., Cipriano, C., Lazaro, E., Couzigou, P., Castera, L., Fleury, H., Lafon, M. E., Masquelier, B., Pellegrin, I., Breilh, D., Blanco, P., Loste, P., Caunègre, L., Bonnal, F., Farbos, S., Ferrand, M., Ceccaldi, J., Tchamgoué, S., De Witte, S., Alexander, Chris, Barrios, Rolando, Braitstein, Paula, Brumme, Zabrina, Chan, Keith, Cote, Helen, Gataric, Nada, Geller, Josie, Guillemi, Silvia, Richard Harrigan, P., Harris, Marrianne, Joy, Ruth, Levy, Adrian, Montaner, Julio, Montessori, Val, Palepu, Anita, Phillips, Elizabeth, Phillips, Peter, Press, Natasha, Tyndall, Mark, Wood, Evan, Bhagani, S., Byrne, P., Carroll, A., Cuthbertson, Z., Dunleavy, A., Geretti, A. M., Heelan, B., Johnson, M., Kinloch de Loes, S., Lipman, M., Madge, S., Marshall, N., Nair, D., Nebbia, G., Prinz, B., Swaden, L., Tyrer, M., Youle, M., Chaloner, C., Grabowska, H., Holloway, J., Puradiredja, J., Ransom, D., Tsintas, R., Bansi, L., Fox, Z., Harris, E., Hill, T., Lampe, F., Lodwick, R., Reekie, J., Sabin, C., Smith, C., Amoah, E., Booth, C., Clewley, G., Garcia Diaz, A., Gregory, B., Labbett, W., Tahami, F., Thomas, M., Read, Ron, Fatkenheuer, G., Schmeisser, N., Voigt, K., Wasmuth, J. C., Wohrmann, A., Infectious diseases, AII - Amsterdam institute for Infection and Immunity, APH - Amsterdam Public Health, Medical Microbiology and Infection Prevention, Paediatric Infectious Diseases / Rheumatology / Immunology, Landsteiner Laboratory, ARD - Amsterdam Reproduction and Development, Graduate School, Cardiology, APH - Global Health, APH - Quality of Care, AII - Infectious diseases, AII - Inflammatory diseases, and Global Health
Subjects: Adult, medicine.medical_specialty, AIDS, CD4 counts, Highly active antiretroviral therapy, HIV, Prognosis, Substance abuse (intravenous), Adolescent, Anti-HIV Agents, Antiretroviral Therapy, Highly Active, CD4 Lymphocyte Count, Europe, HIV Infections, HIV-1, Humans, Middle Aged, North America, Risk Factors, Substance Abuse, Intravenous, Survival Analysis, Pharmacology (medical), Infectious Diseases, Cost effectiveness, Antiretroviral Therapy, Article, Acquired immunodeficiency syndrome (AIDS), Internal medicine, medicine, Highly Active, Survival analysis, Immunodeficiency, business.industry, Transmission (medicine), Hazard ratio, Substance Abuse, medicine.disease, Confidence interval, Physical therapy, Intravenous, business, Cohort study
Abstract: Background: The extent to which the prognosis for AIDS and death of patients initiating highly active antiretroviral therapy (HAART) continues to be affected by their characteristics at the time of initiation (baseline) is unclear. Methods: We analyzed data on 20,379 treatment-naive HIV-1- infected adults who started HAART in 1 of 12 cohort studies in Europe and North America (61,798 person-years of follow-up, 1844 AIDS events, and 1005 deaths). Results: Although baseline CD4 cell count became less prognostic with time, individuals with a baseline CD4 count 350 cells/μL (hazard ratio for AIDS = 2.3, 95% confidence interval [CI]: 1.0 to 2.3; mortality hazard ratio = 2.5, 95% CI: 1.2 to 5.5, 4 to 6 years after starting HAART). Rates of AIDS were persistently higher in individuals who had experienced an AIDS event before starting HAART. Individuals with presumed transmission by means of injection drug use experienced substantially higher rates of AIDS and death than other individuals throughout follow-up (AIDS hazard ratio = 1.6, 95% CI: 0.8 to 3.0; mortality hazard ratio = 3.5, 95% CI: 2.2 to 5.5, 4 to 6 years after starting HAART). Conclusions: Compared with other patient groups, injection drug users and patients with advanced immunodeficiency at baseline experience substantially increased rates of AIDS and death up to 6 years after starting HAART.
Published: 2007

33. Economic evaluation of HIV treatments: The I.CO.N.A. cohort study

Author: Merito, Monica, Bonaccorsi, Andrea, Pammolli, Fabio, Riccaboni, Massimo, Baio, Gianluca, Arici, Claudio, D'Arminio Monforte, Antonella, Pezzotti, Patrizio, Corsini, Dario, Tramarin, Andrea, Cauda, Roberto, Colangeli, Vincenzo, Pastore, Giuseppe, Montroni, M., Scalise, G., Braschi, M. C., Del Prete, M. S., Tirelli, U., Cinelli, R., Ladisa, N., Minafra, G., Suter, F., Chiodo, F., Fiorini, C., Coronado, O., Carosi, G., Cadeo, G. P., Torti, C., Minardi, C., Bertelli, D., Rizzardini, G., Migliorino, G., Manconi, P. E., Piano, P., Ferraro, T., Scerbo, A., Pizzigallo, E., D'Alessandro, M., Santoro, D., Pusterla, L., Carnevale, G., Galloni, D., Viganò, P., Mena, M., Ghinelli, F., Sighinolfi, L., Leoncini, F., Mazzotta, F., Pozzi, M., Lo Caputo, S., Angarano, G., Grisorio, B., Saracino, A., Ferrara, S., Grima, P., Tundo, P., Pagano, G., Cassola, G., Alessandrini, A., Piscopo, R., Toti, M., Chigiotti, S., Soscia, F., Tacconi, L., Orani, A., Perini, P., Scasso, A., Vincenti, A., Chiodera, F., Castelli, P., Scalzini, A., Fibbia, G., Moroni, M., Lazzarin, A., Cargnel, A., Vigevani, G. M., Caggese, L., Repetto, D., Novati, R., Galli, A., Merli, S., Pastecchia, C., Moioli, M. C., Esposito, R., Mussini, C., Abrescia, N., Chirianni, A., Izzo, C. M., Piazza, M., De Marco, M., Viglietti, R., Manzillo, E., Graf, M., Colomba, A., Abbadessa, V., Prestileo, T., Mancuso, S., Ferrari, C., Pizzaferri, P., Filice, G., Minoli, L., Bruno, R., Novati, S., Baldelli, F., Tinca, M., Petrelli, E., Cioppi, A., Alberici, F., Ruggieri, A., Menichetti, F., Martinelli, C., De Stefano, C., La Gala, A., Ballardini, G., Briganti, E., Magnani, G., Ursitti, M. A., Arlotti, M., Ortolani, P., Dianzani, F., Ippolito, G., Antinori, A., Antonucci, G., D'Elia, S., Narciso, P., Petrosillo, N., Vullo, Vincenzo, De Luca, A., Di Giambenedetti, S., Zaccarelli, M., Acinapura, R., De Longis, P., Ciardi, Maria Rosa, D'Offizi, G., Trotta, M. P., Noto, P., Lichtner, Miriam, Capobianchi, M. R., Girardi, E., Rezza, G., Mura, M. S., Mannazzu, M., Resta, F., Loso, K., Caramello, P., Sinicco, A., Soranzo, M. L., Orofino, G., Sciandra, M., Bonasso, M., Grossi, P. A., Basilico, C., Poggio, A., Bottari, G., Raise, E., Pasquinucci, S., De Lalla, F., Tositti, G., and Lepri, A. Cozzi
Subjects: Pediatrics, medicine.medical_specialty, HAART, Settore MED/17 - Malattie Infettive, National Health Programs, Costs per person-year, Health resources, HIV infection, Antiretroviral Therapy, Highly Active, Cohort Studies, Costs and Cost Analysis, HIV Infections, Health Care Costs, Humans, Italy, Health Policy, Antiretroviral Therapy, Indirect costs, Acquired immunodeficiency syndrome (AIDS), medicine, Highly Active, Seroconversion, Health policy, health care economics and organizations, business.industry, Medicine (all), medicine.disease, Antiretroviral therapy, Cohort, Economic evaluation, business, Cohort study
Abstract: Objective: To describe the changes in costs of care for HIV-positive patients in Italy after the spread of antiretroviral combination therapies (HAART).Methods: Five thousand four hundred and twenty-two patients from the I.CO.N.A. (Italian Cohort Naive Antiretrovirals) study were followed between 1997 and 2002. Costs included antiretroviral therapies (ART), hospital admissions, prophylaxis, and main laboratory examinations. The perspective was that of the National Health Service.Results: Admission costs per person-year decreased from 2148 euro in 1997 to 256 in 2002, while the average annual costs of ART increased from 2145 to 3149 euro (1997 prices). From 1997 to]999, ART costs increased from 42.3 to 85.9% of the total, while admission costs decreased from 42.3 to 7.0% and prophylaxis from 7.3 to 1.7%. The breakdown of ART costs shows how dual therapies decreased over time in favor of HAART, falling from 26.8% in 1997 to 5.9% in 2002. Patients with fewer than five treatment switches had the lowest costs distributions over the entire observation period.Conclusions: From 1997 to 2002 inpatient costs progressively decreased in favor of antiretroviral therapy. Annual average costs per patient decreased, while total direct costs increased over time: health resources, initially concentrated on hospitalized patients were then distributed over a growing number of subjects. (c) 2005 Elsevier Ireland Ltd. All rights reserved.
Published: 2005

34. Long-term CD4+ T-cell count evolution after switching from regimens including HIV nucleoside reverse transcriptase inhibitors (NRTI) plus protease inhibitors to regimens containing NRTI plus non-NRTI or only NRTI

Author: Torti, C, d'Arminio Monforte, A, Pozniak, Al, Lapadula, G, Cologni, G, Antinori, A, De Luca, A, Mussini, C, Castagna, A, Cicconi, P, Minoli, L, Costantini, A, Carosi, G, Liang, H, Cesana, Bm, Master, Chelsea, Westminster ICONA Modena, Raffaele HIV Cohortsm, S., Baldelli, Franco, Torti, Carlo, d'Arminio Monforte, A, Pozniak Anton, L., Lapadula, Giuseppe, Cologni, Giuliana, Antinori, Andrea, De Luca, Andrea, Mussini, Cristina, Castagna, Antonella, Cicconi, Paola, Minoli, Lorenzo, Costantini, Andrea, Carosi, Giampiero, Liang, Hua, Cesana Bruno, M., Torti, C, d'Arminio-Monforte, A, Pozniak, A, Lapadula, G, Cologni, G, Antinori, A, De Luca, A, Mussini, C, Castagna, A, Cicconi, P, Minoli, L, Costantini, A, Carosi, G, Liang, H, Cesana, B, and Mancuso, S
Subjects: Adult, CD4-Positive T-Lymphocytes, Male, medicine.medical_treatment, Protease Inhibitor, Human immunodeficiency virus (HIV), CD4+ T-cell, HIV Infections, Biology, medicine.disease_cause, Settore MED/17 - MALATTIE INFETTIVE, Nucleoside Reverse Transcriptase Inhibitor, Time, lcsh:Infectious and parasitic diseases, Zidovudine, Retrospective Studie, immune system diseases, Antiretroviral Therapy, Highly Active, medicine, Humans, Protease inhibitor (pharmacology), HIV Infection, Protease Inhibitors, lcsh:RC109-216, Retrospective Studies, HIV, Protease, Cd4 t cell, Drug Substitution, Background data, virus diseases, Middle Aged, Virology, AIDS, CD4, NRTI, Reverse Transcriptase Inhibitor, CD4 Lymphocyte Count, Infectious Diseases, CD4-Positive T-Lymphocyte, Reverse Transcriptase Inhibitors, Ritonavir, Female, medicine.drug, Human, Research Article
Abstract: Background Data regarding CD4+ recovery after switching from protease inhibitor (PI)-based regimens to regimens not containing PI are scarce. Methods Subjects with virological success on first-PI-regimens who switched to NNRTI therapy (NNRTI group) or to nucleoside reverse transcriptase (NRTI)-only (NRTI group) were studied. The effect of the switch on the ongoing CD4+ trend was assessed by two-phase linear regression (TPLR), allowing us to evaluate whether a change in the CD4+ trend (hinge) occurred and the time of its occurrence. Furthermore, we described the evolution of the frequencies in CD4-count classes across four relevant time-points (baseline, before and immediately after the switch, and last visit). Finally, we explored whether the CD4+ counts evolved differently in patients who switched to NNRTI or NRTI-only regimens by considering: the overall CD4+ trends, the time to CD4+≥ 500/mm3 after the switch, and the area-under-the-curve (AUC) of the CD4+ after the switch. Results Eight hundred and ninety-six patients, followed for a median of 2,121 days, were included. At TPLR, hinges occurred in 581/844 (68.9%), but in only 40/581 (6.9%) within a time interval (180 days) compatible with a possible relationship to the switch; furthermore, in 19/40 cases, CD4+ counts appeared to decrease after the hinges. In comparison with the NNRTI group, the NRTI group showed CD4+ count greater at baseline (P = 0.0234) and before the switch (P ≤ 0.0001), superior CD4+ T-cell increases after HAART was started, lower probability of not achieving CD4+ ≥ 500/mm3 (P = 0.0024), and, finally, no significant differences in the CD4+ T-cell AUC after the switch after adjusting for possible confounders (propensity score and pre-switch AUC). Persistence at CD4+ < 200/mm3 was observed in 34/435 (7.5%) patients, and a decrease below this level was found in only 10/259 (3.9%) with baseline CD4+ ≥ 350/mm3. Conclusions Switching from first-line PI to NNRTI- or NRTI-based regimens did not seem to impair CD4+ trend over long-term follow-up. Although the greater CD4+ increases in patients who switched to the NRTI-only regimen was due to higher CD4+ counts before the switch, several statistical analyses consistently showed that switching to this regimen did not damage the ongoing immune-reconstitution. Lastly, the observation that CD4+ T-cell counts remained low or decreased in the long term despite virological success merits further investigation.

35. Hydroxyurea and didanosine is a more potent combination than hydroxyurea and zidovudine

Author: Foli A, Lori F, Maserati R, Carmine Tinelli, Minoli L, and Lisziewicz J
Subjects: Adult, Male, Didanosine, Anti-HIV Agents, Humans, Hydroxyurea, Drug Therapy, Combination, Female, HIV Infections, Middle Aged, Zidovudine, CD4 Lymphocyte Count
Abstract: The in vitro and in vivo antiviral activity of hydroxyurea in combination with either zidovudine or didanosine was evaluated in primary human peripheral mononuclear cells and in a cohort of 29 asymptomatic patients infected with HIV. In vitro, hydroxyurea alone did not significantly affect HIV replication, whereas the combination of hydroxyurea with didanosine was more effective than the combination of hydroxyurea with zidovudine. Our clinical results confirmed these studies. Patients were randomly assigned to five arms (zidovudine, hydroxyurea or didanosine monotherapy, or hydroxyurea in combination with either zidovudine or didanosine) to evaluate preliminary safety and efficacy. Bone-marrow toxicity occurred in two patients treated with zidovudine plus hydroxyurea, alopecia was reported in one patient treated with hydroxyurea monotherapy, and there were no toxic effects recorded in the remaining three groups. Plasma viraemia was not influenced by hydroxyurea monotherapy, and the hydroxyurea-zidovudine combination did not give any advantage over either zidovudine or didanosine monotherapy (0.3-0.5 log decrease in plasma viraemia). In contrast, a 1.1 log drop in plasma viraemia was observed in patients treated with hydroxyurea plus didanosine, this reduction was sustained throughout the 24-week course of the treatment. Combination therapy with hydroxyurea and didanosine exhibited statistically significant improvements compared with the other therapeutic approaches. Although further clinical trials are required, these results suggest that hydroxyurea in combination with didanosine might be an effective and well-tolerated, simple and affordable, treatment for HIV infection.

36. Seborrhoeic dermatitis: an early manifestation in AIDS.

Author: Senaldi, G., Di Perri, G., Di Silverio, A., and Minoli, L.
Subjects: HIV infections, SKIN inflammation, AIDS
Abstract: The article presents comments of the author on the a article, that reported on the high prevalence of seborrhoeic dermatitis in HTLV-III infection. Seborrhoeic dermatitis in a severe form and AIDS have been repeatedly reported to be associated. The author and colleagues investigated the presence of seborrhoeic dermatitis in 25 consecutive patients who were diagnosed as suffering from AIDS, according to the criteria of the U.S. Centers for Disease Control and Prevention. Results support the observation of a high prevalence of seborrhoeic dermatitis in AIDS, but do not corroborate its peculiarly severe course in this condition. Of potential clinical relevance is the observation that seborrhoeic dermatitis appears as an initial manifestation of AIDS and could therefore prove useful as an early diagnostic marker.
Published: 1987
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37. Headache attributed to infection: observations on the IHS classification (ICHD-II).

Author: Marchioni, E., Tavazzi, E., Bono, G., Minoli, L., Bastianello, S., Sinforiani, E., Sances, G., Tinelli, C., and Nappi, G.
Subjects: *HIV infections, *HEADACHE, *CENTRAL nervous system diseases, *MENINGOENCEPHALITIS, *SYMPTOMS, *NEUROLOGY, *SOCIETIES
Abstract: The aim of this study was to revise some topics in the chapter ‘Headache attributed to infections’ in the last International Headache Society (IHS) classification. The authors searched for original studies and reviews about headache associated with infections. A checklist was submitted to 15 neurologists to quantify the relevance, comprehensibility and coherence between definitions, criteria and comments for each paragraph. The following paragraphs were fully discussed: (1) headache attributed to lymphocytic meningitis. This topic, being rather heterogeneous, should be divided into different subgroups; (2) headache attributed to HIV/AIDS. Distinctive features are not specified and diagnostic criteria are rather confusing; and (3) chronic post-infection headache. Diagnostic criteria should be reconsidered as the symptom ‘pain’ is not the main diagnostic criterion. The authors propose the revision of three paragraphs of the new IHS classification to better define the most likely headache profile in specific CNS infections. The authors also underline the need to plan further ad hoc prospective studies. [ABSTRACT FROM AUTHOR]
Published: 2006
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38. Estimating minimum adult HIV prevalence: A cross-sectional study to assess the characteristics of people living with HIV in Italy

Author: Margherita Busso, Tullio Prestileo, Ermenegildo Francavilla, Marco Anselmo, Francesco Montella, Evangelista Sagnelli, Teresa Santantonio, Massimo Galli, Marcello Saitta, Giuseppe Foti, Cecilia Guariglia, Franco Baldelli, Simona Di Gianbenedetto, Pierluigi Viale, Francesco Castelli, Antonella d'Arminio Monforte, Angelo Pan, Gabriella D’Ettore, Maria Dorrucci, Salvatore Bruno, Tiziana Quirino, Mariangela Raimondo, Alessandro Bartoloni, Vinicio Manfrin, Giovanni Mazzarello, Eugenio Mantia, Raffaele Pempinello, Antonio Traverso, Barbara Suligoi, Fabio Bulla, Pietro Mesina, Alessia Zoncada, Gianfranco Orofino, Oliviero Bosco, Gianmichele Moise, Angelo Salomone Megna, Roberto Ferretto, Mauro Valle, Manuela Colafigli, Claudio Paternoster, S. Artioli, Giovanni Riccio, Stefania Bernardi, Paolo Grossi, Milena Zoppi, Sebastiano Maiuzzo, Giorgio Perboni, Sauro Tini, Giuseppe Ferrea, Nicoletta Ladisa, Enzo M. Farinella, Daniela Francisci, Dino Sgarabotto, Roberto Monarca, Enzo Petrelli, A. Franco, Izzo Cm, Pietro Bellissima, Francesco Ortu, Laura Sighinolfi, Antonio Chirianni, Filippo Bartalesi, Giulio De Stefano, Claudia Colomba, Laura Camoni, Salvatore Galvagna, Benedetto Maurizio Celesia, Andrea Petrucci, Camillo Baretti, Pierluigi Brugnaro, Federica Poletti, Maurilio Chimenti, Camilla Ajassa, Mario Falciano, Rosaria La Sala, Sauro Luchi, V. Portelli, Annamaria Degli Antoni, Francesco Mazzotta, Giuliano Zuccati, Vincenzo Colangeli, Ercole Concia, Giordano Madeddu, Maria Cristina Salfa, Francesca Cattelan, Nicola Acone, Vincenza Regine, Olivia Bargiacchi, Maurizio de Martino, F. Paoletti, Giovanni Cassola, Giuliano Schettino, Carlo De Stefano, Enza Anzalone, D. Aquilini, Giacomo Magnani, Vanni Borghi, Roberta Gastaldi, Alessandra Govoni, Cristina Rossi, Rita Consolini, Gioacchino Angarano, Gloria Taliani, Tommaso Fontana, Sergio Lo Caputo, Davide Vitullo, Pierpaolo Congedo, Emanuela Vaccher, Paolo Viganò, Maria Stella Mura, Claudio Cancellieri, Enrico Girardi, Francesca Savalli, Cecilia Fico, Anna Maria Cattelan, Alessandro Chiodera, Renzo Scaggiante, P. Osimani, Caterina Bramato, Nicola Pietrosillo, Giovanna D'Alessio, Salvatore Bonfante, Vincenzo Vullo, Andrea Gori, Margherita Dalessandro, Domenico Lucchino, Massimo Deseraca, Paolo Tundo, Alfredo Pennica, M. Paoloni, Antonella Castagna, Nicola Serrao, Paolo Costa, Franco Marranconi, Massimo Villa, Pietro Filippini, Maurizio Setti, Eligio Pizzigallo, Marco Tinelli, Mauro Marchili, Domenico Santoro, Cesira Nencioni, Piera Dones, Vincenzo Renda, Alberto Giannetti, Domenico La Rovere, Nicoletta Dorigoni, Guido Palamara, Angelo Iodice, Clara Gabiano, Peter Mian, Luigi Guarnieri, Andrea De Luca, Nicola Tripodi, Giovanni Cristina, Giustino Parruti, Maria Montroni, Loredana Palvarini, Marco Rizzi, Benvenuto Grisorio, Corrado Catalani, Paolo Emilio Manconi, Jacopo Vecchiett, Tiziana Carli, Riccardo Iapoce, Massimo Andreoni, Adriano Lazzarin, Giorgetta Casalino Finocchio, D Sacchini, Mario Gobber, Spartaco Sani, Marco Campus, Rosario La Rosa, Maurizio Mazzeo, Stefano Bonora, Michele Trezzi, Paolo Bassi, Angela La Gala, Alessandro Grimaldi, Dante Di Giammartino, Guido Leo, Gaetano Filice, Antonio Salvo, Paolo Bonfanti, Chiara Pasqualini, Marcello Tavio, Luca Butini, N. Abrescia, Angela Linzalone, Gianpaolo Natalini Ramponi, Pierangelo Rovere, Piero Cortese, Dario Bartolozzi, F. Resta, Miriam Lichtner, Loredana Sarmati, Francesco Cesario, Renato F. Frongillo, Ivano Mezzaroma, Carlo Ferrari, Lorenzo Minoli, Paola Di Stefano, Lucina Titone, Rosa Boncoraglio, Mariana Farenga, Giuliano Rizzardini, Stefano Aviani Barbacci, Andrea Giacometti, Andrea Antinori, Antonio Caterini, Consuelo Geraci, Piergiorgio Chiriacò, Lucio Cosco, Claudio Viscoli, Alfredo Scalzini, Sandro Piga, Massimo Arlotti, Cecilia Occhino, Roberto Luzzati, Paola Sabbatini, Guglielmo Borgia, Umberto Tirelli, Antonio Davi, Letizia Cristiano, Cristina Mussini, Roberto Cauda, Patrizio Vittucci, B. Salassa, Marco Libanore, Maria Pina Sciotti, Isa Picerno, Matteo Bassetti, Benedetto Caroleo, Oswald Moling, Danilo Tacconi, Massimo Puoti, Camoni, Laura, Raimondo, Mariangela, Dorrucci, Maria, Regine V, Salfa MC, CARPHA Study, Group, Lazzarin, Adriano, Castagna, Antonella, Camoni, L, Raimondo, M, Dorrucci, M, Regine, V, Salfa, M, Suligoi, B, Di Giammartino, D, Parruti, G, Di Stefano, P, Paoloni, M, D'Alessandro, M, Grimaldi, A, Sciotti, M, Pizzigallo, E, Vecchiett, J, De Stefano, C, La Gala, A, De Stefano, G, Linzalone, A, Cesario, F, Cosco, L, Caroleo, B, Foti, G, Serrao, N, Lucchino, D, Chirianni, A, Abrescia, N, Pempinello, R, Izzo, C, Borgia, G, Filippini, P, Sagnelli, E, Iodice, A, Megna, A, D'Alessio, G, Acone, N, Mazzeo, M, Sacchini, D, Ferrari, C, Degli Antoni, A, Magnani, G, Mussini, C, Borghi, V, Viale, P, Colangeli, V, Sighinolfi, L, Libanore, M, Govoni, A, Cancellieri, C, Bassi, P, Arlotti, M, Luzzati, R, Bassetti, M, Tirelli, U, Vaccher, E, Moise, G, Palamara, G, Bernardi, S, Falciano, M, Vullo, V, D'Ettore, G, Renda, V, Guariglia, C, Taliani, G, Mezzaroma, I, Paoletti, F, Ajassa, C, Gastaldi, R, Andreoni, M, Sarmati, L, Montella, F, Antinori, A, Giannetti, A, Pietrosillo, N, Girardi, E, Pennica, A, Cauda, R, Colafigli, M, Di Gianbenedetto, S, Caterini, A, Monarca, R, Barbacci, S, Ramponi, G, Marchili, M, Anzalone, E, Lichtner, M, Ferrea, G, Cassola, G, Viscoli, C, Mazzarello, G, Setti, M, Artioli, S, Riccio, G, Finocchio, G, Anselmo, M, Rizzi, M, Scalzini, A, Castelli, F, Quirino, T, Santoro, D, Pan, A, Zoncada, A, Bonfanti, P, Viganò, P, Villa, M, Tinelli, M, Perboni, G, Palvarini, L, Costa, P, Puoti, M, Galli, M, Rizzardini, G, Monforte, A, Lazzarin, A, Castagna, A, Gori, A, Minoli, L, Filice, G, Grossi, P, Giacometti, A, Tavio, M, Montroni, M, Butini, L, Osimani, P, Petrelli, E, Chiodera, A, Vittucci, P, Sabbatini, P, Pasqualini, C, Valle, M, Zoppi, M, Mantia, E, Schettino, G, Deseraca, M, Vitullo, D, Bargiacchi, O, Orofino, G, Bramato, C, Busso, M, Salassa, B, Farenga, M, Bonora, S, Leo, G, Poletti, F, Gobber, M, Cristina, G, Gabiano, C, Mian, P, Moling, O, Paternoster, C, Dorigoni, N, Fontana, T, Angarano, G, Ladisa, N, La Rovere, D, Fico, C, Bulla, F, Santantonio, T, Grisorio, B, Chiriacò, P, Congedo, P, Tundo, P, Resta, F, Cristiano, L, Mura, M, Madeddu, G, Mesina, P, Piga, S, Campus, M, Manconi, P, Ortu, F, Salvo, A, Baretti, C, La Sala, R, Bellissima, P, Bonfante, S, Galvagna, S, Celesia, B, La Rosa, R, Maiuzzo, S, Guarnieri, L, Bruno, S, Picerno, I, Tripodi, N, Farinella, E, Occhino, C, Titone, L, Colomba, C, Prestileo, T, Saitta, M, Dones, P, Boncoraglio, R, Davi, A, Franco, A, Portelli, V, Savalli, F, Geraci, C, Chimenti, M, Luchi, S, Catalani, C, Trezzi, M, Aquilini, D, Sani, S, Nencioni, C, Carli, T, Mazzotta, F, Lo Caputo, S, Zuccati, G, Iapoce, R, Consolini, R, Bartolozzi, D, Bartoloni, A, Bartalesi, F, DE LUCA, A, De Martino, M, Tacconi, D, Tini, S, Baldelli, F, Francisci, D, Frongillo, R, Traverso, A, Francavilla, E, Ferretto, R, Marranconi, F, Manfrin, V, Cortese, P, Rossi, C, Cattelan, F, Petrucci, A, Brugnaro, P, Sgarabotto, D, Scaggiante, R, Cattelan, A, Bosco, O, Concia, E, Rovere, P, Regine, Vincenza, Salfa, Maria Cristina, Suligoi, Barbara, and Luzzati, Roberto
Subjects: Adult, Male, Pediatrics, medicine.medical_specialty, Immunology, Infectious Diseases, Virology, Settore MED/17 - Malattie Infettive, Epidemiology, Cross-sectional study, Human immunodeficiency virus (HIV), MEDLINE, HIV Infections, medicine.disease_cause, Anti-Retroviral Agents, CD4 Lymphocyte Count, Cross-Sectional Studies, Female, Humans, Italy, Middle Aged, Prevalence, Retrospective Studies, medicine, HIV Infection, HIV, prevalence, Italy, Cross-Sectional Studie, business.industry, Transmission (medicine), HIV, Retrospective cohort study, Hiv prevalence, Northern italy, Anti-Retroviral Agent, business, Viral load, Human, Demography
Abstract: In 2012, we conducted a retrospective cross-sectional study to assess the number of people living with HIV linked to care and, among these, the number of people on antiretroviral therapy. The health authority in each of the 20 Italian Regions provided the list of Public Infectious Diseases Clinics providing antiretroviral therapy and monitoring people with HIV infection. We asked every Public Infectious Diseases Clinic to report the number of HIV-positive people diagnosed and linked to care and the number of those on antiretroviral therapy during 2012. In 2012, 94,146 people diagnosed with HIV and linked to care were reported. The majority were males (70.1%), Italians (84.4%), and aged between 25 and 49 years (63.4%); the probable route of transmission was heterosexual contact in 37.5% of cases, injecting drug use in 28.1%, and male-to-male contact in 27.9%. Among people in care, 20.1% had less than 350 CD4 cells/Î¼l, 87.6% received antiretroviral therapy, and among these, 62.4% had a CD4 cell count higher than 350 cells/Î¼l. The overall estimated prevalence of individuals diagnosed and linked to care in 2012 in Italy was 0.16 per 100 residents (all ages). Adding the estimated proportion of undiagnosed people, the estimated HIV prevalence would range between 0.19 and 0.26 per 100 residents. In Italy, the majority of people diagnosed and linked to care receive antiretroviral therapy. A higher prevalence of individuals diagnosed and linked to care was observed in Northern Italy and among males. More information for developing the HIV care continuum is necessary to improve the entire engagement in care, focusing on test-and-treat strategies to substantially reduce the proportion of people still undiagnosed or with a detectable viral load.
Published: 2015

39. Influence of Genotype 3 Hepatitis C Coinfection on Liver Enzyme Elevation in HIV-1-Positive Patients After Commencement of a New Highly Active Antiretroviral Regimen

Author: Giuseppe Pastore, Giovanni Sotgiu, Stefano Bonora, Maria Cristina Uccelli, Massimo Puoti, Graziella Cristini, Giampiero Carosi, Lorenzo Minoli, Carlo Torti, Sergio Lo Caputo, Nicoletta Ladisa, Daniele Bella, Salvatore Casari, Giuseppe Lapadula, Torti, C, Lapadula, G, Puoti, M, Casari, S, Uccelli, M, Cristini, G, Bella, D, Pastore, G, Ladisa, N, Minoli, L, Sotgiu, G, Caputo, S, Bonora, S, and Carosi, G
Subjects: Adult, Male, medicine.medical_specialty, Anti-HIV Agents, Hepatitis C virus, HIV Infections, Hepacivirus, medicine.disease_cause, Gastroenterology, Transaminase, Cohort Studies, Highly active antiretroviral therapy, Species Specificity, Antiretroviral Therapy, Highly Active, Internal medicine, Hepatitis C virus genotype, medicine, Humans, HIV Infection, Pharmacology (medical), Risk factor, Proportional Hazards Models, Hepaciviru, biology, business.industry, Proportional hazards model, Hepatotoxicity, Hazard ratio, HIV, Anti-HIV Agent, Alanine Transaminase, Hepatitis C, medicine.disease, Infectious Diseases, Alanine transaminase, Immunology, Proportional Hazards Model, HIV-1, Coinfection, biology.protein, Female, Cohort Studie, Chemical and Drug Induced Liver Injury, Hepatitis C viru, business, Human
Abstract: Background: The independent role of hepatitis C virus (HCV) genotype 3 in liver transaminase elevation following highly active antiretroviral regimens is still controversial. Methods: Analysis of data from a cohort of 492 HIV/HCV-coinfected patients was conducted using an intention-to-treat approach. Incidence of grade ≥III liver transaminase elevation was estimated per 100 patient-years of follow-up. Univariate and multiple proportional hazards regression analysis of factors that may predict liver enzyme elevation was performed. Results: The incidence of grade ≥III hepatotoxicity was 25 per 100 patient-years among patients coinfected with HCV genotype 3 and 11 per 100 patient-years among those with other genotypes. On multiple proportional hazard regression analysis, time-to-grade ≥III liver enzyme elevation was directly correlated with HCV genotype 3 (hazards ratio [HR]: 2.0, 95% CI: 1.3 to 2.9; P = 0.001), male gender (HR: 2.7; 95% CI: 1.3 to 5.7; P = 0.007), chronic hepatitis B virus infection (HR: 2.9, 95% CI: 1.5 to 5.9; P = 0.002), and alanine aminotransferase level at baseline (per 10 IU/L HR: 1.10; 95% CI: 1.06 to 1.15; P < 0.001). In the same model, higher CD4 + T-cell counts at baseline were inversely correlated with risk of hepatotoxicity (HR: 0.998; 95% CI: 0.997 to 0.999; P = 0.036). Moreover, among patients experienced to antiretroviral drugs, previous grade ≥III hepatotoxicity (HR: 2.8; 95% CI: 1.8 to 4.3; P < 0.001) was an adjunctive independent risk factor. Conclusions: HIV-positive patients coinfected with HCV genotype 3 displayed a higher risk of relevant hepatotoxicity, independently from other clinical variables. The impact of HCV genotype outweighed the role of drugs in determining hepatotoxicity. Copyright © 2006 by Lippincott Williams & Wilkins.
Published: 2006

40. Incidence and risk factors for liver enzyme elevation during highly active antiretroviral therapy in HIV-HCV co-infected patients: results from the Italian EPOKA-MASTER Cohort

Author: Giovanni Di Perri, Gaetano Filice, Eugenia Quiros-Roldan, Giampiero Carosi, Massimo Puoti, Salvatore Casari, Daniele Bella, Nicoletta Ladisa, Francesco Mazzotta, Mark Nelson, Giuseppe Pastore, Sergio Lo Caputo, Giuseppe Lapadula, Lorenzo Minoli, Carmine Tinelli, Carlo Torti, Giovanni Sotgiu, Torti, C, Lapadula, G, Casari, S, Puoti, M, Nelson, M, Quiros-Roldan, E, Bella, D, Pastore, G, Ladisa, N, Minoli, L, Sotgiu, G, Mazzotta, F, Lo Caputo, S, Di Perri, G, Filice, G, Tinelli, C, and Carosi, G
Subjects: Oncology, HIV Infections, Nucleoside Reverse Transcriptase Inhibitor, Cohort Studies, chemistry.chemical_compound, Liver Function Tests, Risk Factors, Retrospective Studie, Antiretroviral Therapy, Highly Active, HIV Infection, medicine.diagnostic_test, Liver Function Test, Incidence, Alanine Transaminase, Hepatitis C, Middle Aged, Infectious Diseases, Italy, Liver, Cohort, Chemical and Drug Induced Liver Injury, Research Article, medicine.drug, Cohort study, Human, Adult, medicine.medical_specialty, Efavirenz, Nevirapine, Anti-HIV Agents, lcsh:Infectious and parasitic diseases, Internal medicine, medicine, Humans, lcsh:RC109-216, Aspartate Aminotransferases, Proportional Hazards Models, Retrospective Studies, business.industry, Risk Factor, Anti-HIV Agent, Retrospective cohort study, Aspartate Aminotransferase, medicine.disease, chemistry, Immunology, Proportional Hazards Model, Cohort Studie, business, Liver function tests
Abstract: Background The risk of hepatotoxicity associated with different highly active antiretroviral therapy (HAART) regimens (containing multiple-protease inhibitors, single-protease inhibitors or non nucleoside reverse transcriptase inhibitors) in HIV-HCV co-infected patients has not been fully assessed. Methods Retrospective analysis of a prospective cohort of 1,038 HIV-HCV co-infected patients who commenced a new HAART in the Italian MASTER database. Patients were stratified into naïve and experienced to antiretroviral therapy before starting the study regimens. Time to grade ≥III hepatotoxicity (as by ACTG classification) was the primary outcome. Secondary outcome was time to grade IV hepatotoxicity. Results Incidence of grade ≥III hepatotoxicity was 17.71 per 100 patient-years (p-yr) of follow up in naïve patient group and 8.22 per 100 p-yrs in experienced group (grade IV: 4.13 per 100 p-yrs and 1.08 per 100 p-yrs, respectively). In the latter group, the only independent factors associated with shorter time to the event at proportional hazards regression model were: previous liver transaminase elevations to grade ≥III, higher baseline alanine amino-transferase values, and use of a non nucleoside reverse transcriptase inhibitor based regimen. In the naive group, baseline aspartate transaminase level was associated with the primary outcome. Conclusion Use of a single or multiple protease inhibitor based regimen was not associated with risk of hepatotoxicity in either naïve or experienced patient groups to a statistically significant extent. A cautious approach with strict monitoring should be applied in HIV-HCV co-infected experienced patients with previous liver transaminase elevations, higher baseline alanine amino-transferase values and who receive regimens containing non nucleoside reverse transcriptase inhibitors.
Published: 2005

41. Predictors of trend in CD4-positive T-cell count and mortality among HIV-1 infected individuals with virological failure to all three antiretroviral-drug classes

Author: Ledergerber, B, Lundgren, Jd, Walker, As, Sabin, C, Justice, A, Reiss, P, Mussini, C, Wit, F, d'Arminio Monforte, A, Weber, R, Fusco, G, Staszewski, S, Law, M, Hogg, R, Lampe, F, Gill, Mj, Castelli, Francesco, Phillips, An, Rooney, P. q, Taylor, S. q, Couldwell, D. r, Austin, D. s, Block, M. s, Clemons, J. s, Finlayson, R. s, Petoumenos, K. s, Quan, D. s, Smith, D. s, O'Connor, C. t, Gorton, C. t, Allen, D. u, Mulhall, B. u, Mutimer, K. v, Keeffe, N. v, Cooper, D. w, Carr, A. w, Miller, J. w, Pell, C. w, Ellis, D. x, Baker, D. y, Kidd, J. y, Mcfarlane, R. y, Liang, M. T. z, Brown, Aa, K., Huffam, Ab, S., Savage, Ab, J., Morgan, Knibbs, Ab, P., Sowden, Ac, D., Walker, Ac, A., Orth, Ad, D., Lister, Ad, G., Chuah, Ae, J., Fankhauser, Ae, W., Dickson, Ae, B., Bradford, Af, D., Wilson, Af, C., Ree, Ag, H., Magon, Anderson, Ah, J., Moore, Ah, R., Russell, Ah, D., Mcgovern, Ah, G., Mcnair, Bal, Fairley, Ah, K., Roth, Ai, N., Ai, B., Strecker, Ai, S., Ai, D., Wood, Ai, H., Mijch, Aj, A., Hoy, Aj, J., Pierce, Mccormack, Aj, C., Watson, Aj, K., Medland, Ak, N., Daye, Al, J., Mallal, Am, S., French, Am, M., Skett, Am, J., Maxwel, Am, D., Cain, Am, A., Montroni, An, M., Scalise, An, G., Costantini, An, A., Giacometti, Tirelli, Ao, U., Nasti, Ao, G., Pastore, Ap, G., Ladisa, Ap, N., Perulli, M. L., Ap, Suter, Aq, F., Arici, Aq, C., Maggiolo, Chiodo, Ar, F., Gritti, F. M., Ar, Colangeli, Ar, V., Fiorini, Ar, C., Guerra, Ar, L., Carosi, As, G., Cadeo, G. P., As, Minardi, As, C., Vangi, As, D., Paraninfo, Casari, As, S., Pan, As, A., Patroni, Torti, Quiros, Roldan, As, E., Tomasoni, As, L., Moretti, As, F., Nasta, As, P., Uccelli, M. C., As, Bertelli, Rizzardini, At, G., Migliorino, At, M., Abeli, At, C., Manconi, P. E., Au, Piano, Au, P., Ferraro, Av, T., Scerbo, Av, A., Pizzigallo, Aw, E., Ricci, Aw, F., Santoro, Ax, D., Pusterla, Ax, L., Carnevale, Ay, G., Galloni, Ay, D., Viganò, Az, P., Mena, Az, M., Ghinelli, Ba, F., Sighinolfi, Ba, L., Leoncini, Bb, F., Mazzotta, Pozzi, Bb, M., Caputo, Lo, Bb, S., Angarano, Bc, G., Grisorio, Bc, B., Ferrara, Bc, S., Grima, Bd, P., Tundo, Pagano, Be, G., Piersantelli, Be, N., Alessandrini, Be, A., Piscopo, Be, R., Toti, Bf, M., Chigiotti, Bf, S., Soscia, Bg, F., Tacconi, Bg, L., Orani, Bh, A., Perini, Bh, P., Nigro, Bh, M., Scasso, Bi, A., Vincenti, Scalzini, Bj, A., Fibbia, Bj, G., Moroni, Bk, M., Lazzarin, Bk, A., Cargnel, Vigevani, G. M., Bk, Caggese, Bk, L., Tordato, Bk, F., Novati, Bk, R., Galli, Merli, Bk, S., Pastecchia, Bk, C., Moioli, Esposito, Bl, R., Abrescia, Bm, N., Chirianni, Bm, A., Izzo, Bm, C., Piazza, Bm, M., Marco, De, Montesarchio, Bm, V., Manzillo, Bm, E., Nappa, Bm, S., Colomba, Bn, A., Abbadessa, Bn, V., Prestileo, Bn, T., Mancuso, Bn, S., Ferrari, Bo, C., Pzzaferri, Bo, P., Filice, Bp, G., Minoli, Bp, L., Bruno, Bp, R., Maserati, Bp, S., Tinelli, Bp, C., Pauluzzi, Bq, S., Baldelli, Bq, F., Petrelli, Br, E., Cioppi, Br, A., Alberici, Bs, F., Ruggieri, Bs, A., Menichetti, Bt, F., Martinelli, Bt, C., Stefano, De, Bu, C., Gala, La, Bu, A., Zauli, Bv, T., Ballardini, Bv, G., Magnani, Bw, G., Ursitti, M. A., Bw, Arlotti, Bx, M., Ortolani, Bx, P., Ortona, By, L., Dianzani, By, F., Ippolito, By, G., Antinori, Bz, A., Antonucci, Bz, G., D'Elia, Bz, S., Narciso, Bz, P., Petrosillo, Bz, N., Vullo, Bz, V., Luca, De, Del, Forno, Bz, L., Zaccarelli, Bz, M., Longis, De, Ciardi, D'Offizi, Noto, Lichtner, Capobianchi, M. R., Bz, Girardi, Bz, E., Pezzotti, Rezza, Mura, M. S., Ca, Mannazzu, Ca, M., Caramello, Cb, P., Sinicco, Cb, A., Soranzo, M. L., Cb, Gennero, Cb, L., Sciandra, Cb, M., Salassa, Cb, B., Grossi, P. A., Cc, Basilico, Cc, C., Poggio, Cd, A., Bottari, Cd, G., Raise, Ce, E., Pasquinucci, Ce, S., Lalla, De, Cf, F., Tositti, Cf, G., Resta, Cg, F., Chimienti, Cg, A., Lepri, Cozzi, Ch, A., Bachmann, Fb, S., Battegay, Fb, M., Bernasconi, Fb, E., Bucher, Fb, H., Bürgisser, Fb, P., Cattacin, Egger, Erb, Fierz, Fb, W., Fischer, Flepp, Fontana, Fb, A., Francioli, Furrer, H. J., Fb, Gorgievski, Günthard, Hirschel, Fb, B., Kaiser, Fb, L., Kind, Fb, C., Klimkait, Fb, T., Lauper, Fb, U., Opravil, Paccaud, Fb, F., Pantaleo, Fb, G., Perrin, Piffaretti, J. C., Fb, Rickenbach, Rudin, Schüpbach, Fb, J., Speck, Fb, R., Tarr, Telenti, Trkola, Vernazza, Yerly, Wolf, De, Ci, F., Van, Sighem, A. I., Ci, Van, Valkengoed, Ci, I., Gras, Ci, L., Bronsveld, Ci, W., Veldkamp, Ci, A., Prins, J. M., Cj, Bos, J. C., Cj, Schattenkerk, Eeftinck, J. K. M., Cj, Godfried, M. H., Cj, Lange, J. M. A., Cj, Lowe, S. H., Cj, van der Meer, J. T. M., Cj, Nellen, F. J. B., Cj, Pogany, Cj, K., van der Poll, Cj, T., Ruys, T. A., Cj, Sankatsing, Cj, S., van der Valk, Cj, M., Van, Vonderen, M. G. A., Cj, Wit, F. W. M. N., Cj, Van, Eeden, Cj, A., Ten, Veen, J. H., Cj, Van, Dam, P. S., Cj, Hillebrand, Haverkort, M. E., Cj, Brinkman, Frissen, P. H. J., Cj, Weigel, H. M., Cj, Mulder, J. W., Cj, Van, Gorp, E. C. M., Cj, Meenhorst, P. L., Cj, Mairuhu, A. T. A., Cj, Veenstra, Cj, J., Danner, S. 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E., Dv, Angelis, De, Dv, D., Fb, K., Dw, A., Dw, S., Dw, J., Tyrer, Dw, F., Beral, Fb, V., Fb, N., Raffanti, Becker, Scarsella, Braun, Most, Balu, Gilbert, Fleenor, Ising, Dieterich, Fb, D., Fusco, Losso, Dx, M., Duran, Dx, A., Vetter, Dy, N., Clumeck, Dz, N., Wit, De, Dz, S., Kabeya, Dz, K., Poll, Dz, B., Colebunders, Dz, R., Machala, Ea, L., Rozsypal, Ea, H., Nielsen, Eb, J., Lundgren, Eb, O., Olsen, C. H., Eb, Gerstoft, Katzenstein, Eb, T., Hansen, A. B. E., Eb, Skinhøj, Eb, P., Eb, C., Zilmer, Ec, K., Rauka, Ec, M., Katlama, Ed, C., De, Sa, Ed, M., Viard, J. P., Ed, Saint, Marc, Ed, T., Ed, P., Pradier, Dietrich, Ee, M., Manegold, Ee, C., Van, Lunzen, Ee, J., Stellbrink, H. J., Ee, Miller, Ee, V., Goebel, F. 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M., Es, Miró, Zamora, Blaxhult, Et, A., Karlsson, Pehrson, Et, P., Eu, P., Eu, B., Schiffer, Eu, V., Eu, H., Chentsova, Ev, N., Barton, Ew, S., A. M., Ew, Mercey, Ew, D., Phillips, Ew, A., Youle, Ew, M., M. A., Ew, Mocroft, Murphy, Weber, Ew, J., Scullard, Ew, G., Fisher, Ew, R., Loveday, Ew, C., Ex, B., Ruiz, Ex, L., Helm, E. B., Fb, Carlebach, Mösch, Müller, Haberl, Korn, Stephan, Bickel, Gute, Locher, Lutz, Klauke, Doerr, H. W., Fb, Stürmer, Dauer, Jennings, Alexander, Braitstein, Chan, Cote, Gataric, Harrigan, P. R., Fb, Harris, Bonner, Montaner, O'Shaughnessy, Yip, Chaloner, Gumley, Ransom, Sabin, C. A., Fb, Lipman, Ey, J., Read, Ey, R., Ez, F., Riccio, Fa, G., Borghi, AII - Amsterdam institute for Infection and Immunity, APH - Amsterdam Public Health, Infectious diseases, Global Health, Other departments, Public and occupational health, General Internal Medicine, Center of Experimental and Molecular Medicine, Ledergerber, B, Lundgren, Jd, Walker, A, Sabin, C, Justice, A, Reiss, P, Mussini, C, Wit, F, Monforte, Ad, Weber, R, Fusco, G, Staszewski, S, Law, M, Hogg, R, Lampe, F, Gill, Mj, Castelli, F, Phillips, An, Fusco, Gp, Rooney, P, Taylor, S, Couldwell, D, Austin, D, Block, M, Clemons, J, Finlayson, R, Petoumenos, K, Quan, D, Smith, D, O'Connor, C, Gorton, C, Allen, D, Mulhall, B, Mutimer, K, Keeffe, N, Cooper, D, Carr, A, Miller, J, Pell, C, Ellis, D, Baker, D, Kidd, J, Mcfarlane, R, Liang, Mt, Brown, K, Huffam, S, Savage, J, Morgan, S, Knibbs, P, Sowden, D, Orth, D, Lister, G, Chuah, J, Fankhauser, W, Dickson, B, Bradford, D, Wilson, C, Ree, H, Magon, H, Anderson, J, Moore, R, Russell, D, Mcgovern, G, Mcnair, R, Bal, J, Fairley, K, Roth, N, Eu, B, Strecker, S, Wood, H, Mijch, A, Hoy, J, Pierce, A, Mccormack, C, Watson, K, Medland, N, Daye, J, Mallal, S, French, M, Skett, J, Maxwel, D, Cain, A, Montroni, M, Scalise, G, Costantini, A, Giacometti, A, Tirelli, U, Nasti, G, Pastore, G, Ladisa, N, Perulli, Ml, Suter, F, Arici, C, Chiodo, F, Gritti, Fm, Colangeli, V, Fiorini, C, Guerra, L, Carosi, G, Cadeo, Gp, Minardi, C, Vangi, D, Rizzardini, G, Migliorino, G, Manconi, Pe, Piano, P, Ferraro, T, Scerbo, A, Pizzigallo, E, Ricci, F, Santoro, D, Pusterla, L, Carnevale, G, Galloni, D, Vigano, P, Mena, M, Ghinelli, F, Sighinolfi, L, Leoncini, F, Mazzotta, F, Pozzi, M, Lo Caputo, S, Angarano, G, Grisorio, B, Ferrara, S, Grima, P, Tundo, P, Pagano, G, Piersantelli, N, Alessandrini, A, Piscopo, R, Toti, M, Chigiotti, S, Soscia, F, Taccooni, L, Orani, A, Perini, P, Scasso, A, Vincenti, A, Scalzini, A, Fibbia, G, Moroni, M, Lazzarin, A, Cargnel, A, Vigevani, Gm, Caggese, L, Tordato, F, Novati, R, Galli, A, Merli, S, Pastecchia, C, Moioli, C, Esposito, R, Abrescia, N, Chirianni, A, Izzo, C, Piazza, M, De Marco, M, Montesarchio, V, Manzillo, E, Nappa, S, Colomba, A, Abbadessa, V, Prestileo, T, Mancuso, S, Ferrari, C, Pzzaferri, P, Filice, G, Minoli, L, Bruno, R, Maserati, R, Pauluzzi, S, Baldelli, F, Petrelli, E, Cioppi, A, Alberici, F, Ruggieri, A, Menichetti, F, Martinelli, C, De Stefano, C, La Gala, A, Zauli, T, Ballardini, G, Magnani, G, Ursitti, Ma, Arlotti, M, Ortolani, P, Ortona, L, Dianzani, F, Ippolito, G, Antinori, A, Antonucci, G, D'Elia, S, Narciso, P, Petrosillo, N, Vullo, V, De Luca, A, Del Forno, L, Zaccarelli, M, De Longis, P, Ciardi, M, D'Offizi, G, Noto, P, Lichtner, M, Capobianchi, Mr, Girardi, E, Pezzotti, P, Rezza, G, Mura, M, Mannazzu, M, Caramello, P, Sinicco, A, Soranzo, Ml, Gennero, L, Sciandra, M, Salassa, B, Grossi, Pa, Basilico, C, Poggio, A, Bottari, G, Raise, E, Pasquinucci, S, De Lalla, F, Tositti, G, Resta, F, Chimienti, A, Lepri, Ac, Bachmann, S, Battegay, M, Bernasconi, E, Bucher, H, Burgisser, P, Cattacin, S, Egger, M, Erb, P, Fierz, W, Fischer, M, Flepp, M, Fontana, A, Francioli, P, Furrer, Hj, Gorgievski, M, Hirschel, B, Kaiser, L, Kind, C, Klimkait, T, Lauper, U, Opravil, M, Paccaud, F, Pantaleo, G, Perrin, L, Piffaretti, Jc, Rickenbach, M, Rudin, C, Schupbach, J, Speck, R, Tarr, P, Telenti, A, Trkola, A, Vernazza, P, Yerly, S, de Wolf, F, van Sighem, Ai, van Valkengoed, I, Gras, L, Bronsveld, W, Prins, Jm, Bos, Jc, Schattenkerk, Jkme, Godfried, Mh, Lange, Jma, Lowe, Sh, van der Meer, Jtm, Nellen, Fjb, Pogany, K, van der Poll, T, Ruys, Ta, Sankatsing, S, van der Valk, M, van Vonderen, Mga, Wit, Fwmn, van Eeden, A, ten Veen, Jh, van Dam, P, Hillebrand Haverkort, Me, Brinkman, K, Frissen, Phj, Weigel, Hm, Mulder, Jw, van Gorp, Ecm, Meenhorst, Pl, Mairuhu, Ata, Veenstra, J, Danner, Sa, Van Agtmael, Ma, Claessen, Fap, Geerlings, Se, Perenboom, Rm, Richter, C, van der Berg, J, van Leusen, R, Vriesendorp, R, Jeurissen, Fjf, Kauffmann, Rh, Koger, Elw, Bravenboer, B, ten Napel, Chh, Mudrikova, T, Sprenger, Hg, Miesen, Wmaj, ten Kate, Rw, van Houte, Dpf, Leemhuis, Mp, Pole, M, Kroon, Fp, Schippers, Ef, Schreij, G, van de Geest, S, Verbon, A, Koopmans, Pp, Telgt, M, van der Ven, Ajam, van der Ende, Me, Gyssens, Ic, de Marie, S, Nouwen, Jl, Juttmann, Jr, Schneider, Mme, Bonten, Mjm, Borleffs, Jcc, Hoepelman, Im, Jaspers, Cajj, Schouten, I, Schurink, Cam, Blok, Wl, Groenveld, Php, Jurriaans, S, Back, Nkt, Cuijpers, T, Rietra, Pjgm, Roozendaal, Kj, Pauw, W, van Zanten, Ap, Smits, Phm, von Blomberg, Bme, Savelkoul, P, Zaaijer, H, Swanink, C, Franck, Pfh, Lampe, A, Jansen, Cl, Hendriks, R, Schirm, J, Benne, D, Veenendaal, D, Storm, H, van Zeijl, Jh, Kroes, Acm, Claas, Hcj, Bruggeman, Camva, Goossens, Vj, Galama, Jmd, Poort, Yagm, Niesters, Mg, Osterhaus, Adme, Schutten, M, Buiting, Agm, Swaans, Cam, Boucher, Cab, Schuurman, R, Boel, E, Jansz, Af, Veldkamp, A, Beijnen, Jh, Crommentuyn, Kml, Huitema, Adr, Kappelhoff, B, de Maat, Mmr, Burger, Dm, Hugen, Pwh, Dabis, F, Thiebaut, R, Chene, G, Lawson Ayayi, S, Meyer, L, Boufassa, F, Hamouda, O, Touloumi, G, Hatzakis, A, Karafoulidou, A, Katsarou, O, Brettle, R, Del Amo, J, del Romero, J, van Asten, L, van Benthem, B, Prins, M, Coutinho, R, Kirk, O, Pedersen, C, Aguado, Ih, Perez Hoyos, S, Eskild, A, Bruun, Jn, Sannes, M, Lee, C, Johnson, Am, Babiker, A, Darbyshire, J, Gill, N, Porter, K, Vanhems, P, Kaldor, J, Ashton, L, Vizzard, J, Muga, R, Gill, J, Cayla, J, de Olalla, Pg, Day, Ne, De Angelis, D, Walker, S, Tyrer, F, Beral, V, Raffanti, S, Becker, S, Scarsella, A, Braun, J, Most, B, Balu, R, Gilbert, L, Fleenor, R, Ising, T, Dieterich, D, Fusco, J, Losso, M, Duran, A, Vetter, N, Clumeck, N, De Wit, S, Kabeya, K, Poll, B, Colebunders, R, Machala, L, Rozsypal, H, Nielsen, J, Lundgren, J, Olsen, Ch, Gerstoft, J, Katzenstein, T, Hansen, Abe, Skinhoj, P, Zilmer, K, Rauka, M, Katlama, C, De Sa, M, Viard, Jp, Saint Marc, T, Pradier, C, Dietrich, M, Manegold, C, van Lunzen, J, Stellbrink, Hj, Miller, V, Goebel, Fd, Salzberger, B, Rockstroh, J, Kosmidis, J, Gargalianos, P, Sambatakou, H, Perdios, J, Panos, G, Filandras, A, Banhegyi, D, Mulcahy, F, Yust, I, Burke, M, Pollack, S, Hassoun, J, Sthoeger, Z, Maayan, S, Vella, S, Chiesi, A, Pristera, R, Gabbuti, A, Bedini, A, Montesarchio, E, Santopadre, P, Franci, P, Castagna, Antonella, Viksna, L, Rozentale, B, Chaplinskas, S, Hemmer, R, Staub, T, Bruun, J, Maeland, A, Ormaasen, V, Knysz, B, Gasiorowski, J, Horban, A, Prokopowicz, D, Wiercinska Drapalo, A, Boron Kaczmarska, A, Pynka, M, Beniowski, M, Trocha, H, Smiatacz, T, Antunes, F, Mansinho, K, Maltez, F, Duiculescu, D, Streinu Cercel, A, Mokras, M, Stanekova, D, Gonzalez Lahoz, J, Diaz, B, Garcia Benayas, T, Martin Carbonero, L, Soriano, V, Clotet, B, Jou, A, Conejero, J, Tural, C, Gatell, Jm, Miro, Jm, Zamora, L, Blaxhult, A, Karlsson, A, Pehrson, P, Schiffer, V, Furrer, H, Chentsova, N, Barton, S, Mercey, D, Phillips, A, Youle, M, Johnson, Ma, Mocroft, A, Murphy, M, Weber, J, Scullard, G, Fisher, M, Loveday, C, Ruiz, L, Helm, Eb, Carlebach, A, Mosch, M, Muller, A, Haberl, A, Korn, S, Stephan, C, Bickel, M, Gute, P, Locher, L, Lutz, T, Klauke, S, Doerr, Hw, Sturmer, M, Dauer, B, Jennings, B, Alexander, C, Braitstein, P, Chan, K, Cote, H, Gataric, N, Harrigan, Pr, Harris, M, Bonner, S, Montaner, J, O'Shaughnessy, M, Wood, E, Yip, B, Chaloner, C, Gumley, H, Ransom, D, Sabin, Ca, Lipman, M, Johnson, M, Read, R, Paraninfo, G, Casari, S, Pan, A, Patroni, A, Torti, C, Quiros Roldan, E, Tomasoni, L, Moretti, F, Nasta, P, Uccelli, Mc, Bertelli, D, Nigro, M, Migliorino, M, Abeli, C, Maggiolo, F, Novati, S, Tinelli, C, Riccio, G, Borghi, V, and Esposito, R.
Subjects: Male, HAART, Human immunodeficiency virus (HIV), CD4 cell count, HIV Infections, CLINICAL PROGRESSION, medicine.disease_cause, THERAPY, HAART REGIMEN, Cohort Studies, Risk Factors, Adult, Anti-Retroviral Agents, CD4 Lymphocyte Count, Cohort Studies, Female, Follow-Up Studies, HIV Infections, HIV Protease Inhibitors, HIV-1, Humans, Male, Middle Aged, Proportional Hazards Models, Reverse Transcriptase Inhibitors, Risk Factors, Treatment Failure, Viral Load, Medicine, Treatment Failure, Mortality rate, Medicine (all), INHIBITOR, General Medicine, Middle Aged, HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1), BLIND CONTROLLED-TRIAL, medicine.anatomical_structure, Anti-Retroviral Agents, Cohort, HUMAN-IMMUNODEFICIENCY-VIRUS, Reverse Transcriptase Inhibitors, Female, Off Treatment, Viral load, Cohort study, Adult, medicine.medical_specialty, Settore MED/17 - Malattie Infettive, T cell, Internal medicine, Humans, COHORT, Proportional Hazards Models, business.industry, Proportional hazards model, DISEASE PROGRESSION, HIV Protease Inhibitors, HIV-INFECTED INDIVIDUALS, CD4 Lymphocyte Count, VIRAL LOAD, Immunology, HIV-1, business, Follow-Up Studies
Abstract: Background Treatment strategies for patients in whom HIV replication is not suppressed after exposure to several drug classes remain unclear. We aimed to assess the inter-relations between viral load, CD4-cell count, and clinical outcome in patients who had experienced three-class virological failure.Methods We undertook collaborative joint analysis of 13 HIV cohorts from Europe, North America, and Australia, involving patients who had had three-class virological failure (viral load >1000 copies per mL for >4 months). Regression analyses were used to quantify the associations between CD4-cell-count slope, HIV-1 RNA concentration, treatment information, and demographic characteristics. Predictors of death were analysed by Cox's proportional-hazards models.Findings 2488 patients were included. 2118 (85%) had started antiretroviral therapy with single or dual therapy. During 5015 person-years of follow-up, 276 patients died (mortality rate 5.5 per 100 person-years; 3-year mortality risk 15.3% (95% Cl 13.5-17.3). Risk of death was strongly influenced by the latest CD4-cell count with a relative hazard of 15.8 (95% CI 9.28-27.0) for counts below 50 cells per muL versus above 200 cells per muL. The latest viral load did not independently predict death. For any given viral load, patients on treatment had more favourable CD4-cell-count slopes than those off treatment. For patients on treatment and with stable viral load, CD4-cell counts tended to be increasing at times when the current viral load was below 10 000 copies per mL or 1.5 log(10) copies per mL below off-treatment values.Interpretation In patients for whom viral-load suppression to below the level of detection is not possible, achievement and maintenance of a CD4-cell count above 200 per muL becomes the primary aim. Treatment regimens that maintain the viral load below 10 000 copies per mL or at least provide 1.5 log(10) copies per mL suppression below the off-treatment value do not seem to be associated with appreciable CD4-cell-count decline.
Published: 2004

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