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Objective In this paper, we describe the main objectives, the study design and the onset of the patient cohort of the German Competence Network for HIV/AIDS (KompNet). Furthermore, we depict sociodemographic and clinical baseline characteristics and an estimation of the coverage and representativity as to the composition of persons living with HIV/AIDS (PLWHA) in Germany. Methods The KompNet cohort is an open, retrospective and prospective, multicenter, disease-specific and nationwide cohort study that started gathering data in June 2004. Semi-annually, follow up visits of the patients are documented, covering clinical and sociodemographic data. At enrolment and three years afterwards, an EDTA-sample is taken; a serum-sample is taken at every follow up visit. Results As of 14.9.2008, a total of 15,541 patients were enrolled by 44 documenting sites. In September 2007, the cohort size was reduced to 10 outpatient clinics and fifteen private practitioners, covering a total of 9,410 patients. The documentation of these patients comprises 24,117 years of follow up-time since enrolment (mean: 2.6 years), 62,862 person years inclusive data documented retrospectively on course of HIV-infection and combined antiretroviral therapy (cART, mean: 6.7 years). 1,008 patients (10.7%) were lost to follow up and 175 (1.9%) died since enrolment. 84.9% of patients were men. Main risks of transmission were sex between men (MSM: 62.9%), heterosexual contacts (18.4%), intravenous drug use (IVDU: 7.0%) and origin from a high prevalence country (HPL: 5.2%). Mean age was 45 years. Conclusion The KompNet cohort covers about a quarter of all patients being under treatment in Germany. The composition of the cohort represents well the most important risks of transmission in Germany. The cohort contains a high proportion of patients being older than 49 years (28.1%). On basis of its comprehensive database and its biomaterials banks, the KompNet cohort serves as an important instrument to monitor and analyse the effects of combined antiretroviral therapy (cART) in Germany, interdigidating basis, clinical and psychosocial research in view to translational research.

CCR5 antagonists are a newly developed class of antiretroviral drugs which inhibit viral entry into the host cell by binding to the predominant HIV coreceptor. Data on the use of these new drugs in treatment-experienced HIV patients are emerging. Clinical trials on maraviroc and vicriviroc in pretreated patients recruited more than 1300 individuals. Interim results of these studies indicate that pretreated patients infected with CCR5-tropic viruses benefit from their use in optimized combination regimens. Maraviroc reduces the HIV-1 viral load in patients with previous triple-class failure by 1.96 log10 copies/ml versus 0.99 log10 copies/ml in placebo; vicriviroc shows potency by dose depending viral decrease of 1.51-1.68 log10 copies/ml compared to 0.29 log10 in placebo. As expected, CCR5 antagonists do not reduce viral load in patients harbouring CXCR4-tropic or dual/mixed tropic viruses. Nevertheless, since a considerable percentage of late-stage HIV patients still bear CCR5-tropic viruses, the use of CCR5 antagonists appears promising in properly selected treatment-experienced patients.

Dt. Version erschienen u.d.T.: Streptokokkeninfektionen der Haut und Schleimhäute ([https://doi.org/10.1111/j.1610-0387.2007.06287_supp.x](https://doi.org/10.1111/j.1610-0387.2007.06287_supp.x))

The objective was to evaluate the feasibility and efficacy of a short-term, multi-agent and dose intensive regimen in AIDS patients with Burkitt or Burkitt-like lymphoma (BL/BLL) and to compare its efficacy with that of a conventional regimen. This was a retrospective, multi-center cohort study of all HIV-1-infected patients diagnosed with BL/BLL between 1990 - 2004. Patients were assigned to two different chemotherapy approaches. Group A received a protocol which was adapted from the German multi-center study group for adult acute lymphoblastic leukemia (GMALL). Group B received a conventional CHOP-based chemotherapy. Fifty-one patients were included in the analysis. In group A (n = 20), significantly more patients achieved complete remission (75% vs 40%, P = 0.02) than in group B (n = 31). One-year survival in group A was 65% compared to 44% in group B (P = 0.17). In a multi-variable Cox regression analysis, treatment according to the GMALL protocol was significantly associated with prolonged survival with a relative hazard rate of 0.13 (95% CI 0.03 - 0.63, P = 0.01). In conclusion, the short and intensive GMALL protocol for B-ALL/NHL is feasible in patients with AIDS-BL/BLL. Outcome may be improved compared to patients treated with CHOP-based regimens. In the era of HAART, more intensive chemotherapy regimens should be considered in patients with highly aggressive lymphomas.

A one-tablet, once-daily abacavir/lamivudine fixed-dose combination (FDC) has been recently approved to treat HIV-1 infection.A randomized, open-label, parallel-group, multicenter study to compare the efficacy and safety of the FDC group to the separate entities (SE) group, in combination with tenofovir and a new protease inhibitor or nonnucleoside reverse transcription inhibitor in antiretroviral-experienced adults experiencing virologic failure (VF). Eligible subjects had viral loads1000 copies/mL withor =3 nucleoside reverse transcription inhibitor-associated mutations. The primary efficacy end point was time-average changed from baseline (average area under the curve minus baseline) in plasma HIV-1 RNA over 48 weeks.A total of 186 subjects were enrolled. The average area under the curve minus baseline was -1.65 and -1.83 log10 copies/mL in the FDC and SE groups, respectively (intention to treat; 95% confidence interval: -0.13, 0.38). Patients in the FDC (50%) and SE groups (47%) achieved viral loads50 copies/mL based on the time to loss of virologic response algorithm. VF was low and similar in both groups (FDC, 16%; SE, 18%). Tolerability was similar between the 2 groups.The FDC group had noninferior efficacy over 48 weeks to the SE group in treatment-experienced subjects with VF.

Therapeutic drug monitoring (TDM) is gaining importance for improving the success of antiretroviral treatment in human immunodeficiency virus-infected patients. However, enfuvirtide (ENF) concentrations are not regularly determined. The objective of this work was to study the pharmacokinetics (PK) of ENF in patients treated in routine clinical settings, to develop a population PK model describing the concentration-time profile, and to establish PK reference values. A liquid chromatography-tandem mass spectrometry method was developed and applied to serum samples submitted for TDM. A two-compartment model with linear absorption and elimination was fitted to 329 concentrations from 131 patients. The PK model was used for simulations resulting in percentile curves for ENF levels for the full dosing interval. The model predicted that a median concentration of 1,968 ng/ml would be reached 12 h after administration of 90 mg of ENF, and 23% and 58% of patients are expected to have concentrations below 1,000 ng/ml and 2,200 ng/ml, respectively. Both values have been proposed as cutoffs for virological efficacy. The median maximum concentration of drug in serum (Cmax) of 3,943 ng/ml, predicted for 3 h after drug administration, is lower than the Cmax reported previously. We found an enormous interpatient variability at every time point, with concentration spectrums covering >1 log and 52% and 123% interindividual variabilities in the typical clearance and volume of distribution, respectively, in contrast to preexisting PK data. In summary, ENF levels are lower and more variable than expected. Many patients may achieve insufficient concentrations. Further covariate analysis in the population PK model might help to identify factors influencing the variability in ENF concentrations. Therapeutic drug monitoring (TDM) of protease inhibitors (PI) and nonnucleoside inhibitors of the reverse transcriptase (NNRTI) is slowly becoming established as an important tool for improving the success of antiretroviral treatment of human immunodeficiency virus (HIV)-infected patients. The ATHENA trial has shown that nelfinavir concentrations below a certain threshold are associated with high rates of virological failure (3, 4). Patients taking efavirenz also have lower chances of sustained viral suppressions when drug concentrations are below 1,000 ng/ml than when they are above this concentration (17). At the other end of the concentration spectrum, TDM may be beneficial for patients with excessive toxic drug effects. Concentration-controlled dose reductions in patients on ritonavir-boosted indinavir who suffer from renal toxicity may alleviate side effects without increasing the risk of therapeutic failure (3). With monitoring of drug levels, individual patients with extremely low or high concentrations can be identified, and a search for the underlying cause can be started, preventing precocious viral failure or unnecessary toxicity. The grow

Classical sexually transmitted diseases, including syphilis and gonorrhea, have recently increased significantly among homosexual men in Hamburg. During the last year we also observed an increase in patients with lymphogranuloma venereum (LGV) at the ifi-institute in Hamburg. In 2003, we identified 4 homosexual patients with LGV in different clinical stages. None of the patients has traveled outside Germany. Three of these patients were HIV-infected. In all cases Chlamydia trachomatis was identified by SDA (strand displacement amplification) in genital swabs or lymph node aspirates. In three cases sequencing of ompA PCR products was performed and in each instance revealed the C. trachomatis serovar L2. Other important genital pathogens were excluded by specific PCR tests, bacteriological and serological tests. LGV should be included in the differential diagnosis of anogenital and oral erosions, especially in homosexual patients and HIV-infected patients. Novel nucleic acid amplification tests can be used for the rapid and reliable diagnosis of LGV by identifying Chlamydia trachomatis.

This study was undertaken to analyze the differentiation profiles assessed by immunophenotyping in AIDS-related B-cell lymphoma (ARL) and their relation to the clinical course. Paraffin-embedded sections of 89 ARL cases during 1989 to 2004 were stained immunohistochemically with antibodies to CD3, CD10, CD20, CD38, CD138/Syndecan-1 (Syn-1), multiple myeloma-1/interferon regulatory factor-4 (MUM1/IRF4), B-cell lymphoma protein-2 (BCL-2), BCL-6, latent membrane protein-1 (LMP-1), and Ki-67. Expression of CD10 and CD20 were associated with better overall survival (OS; P = .009 and P = .04, respectively). Expression of CD20 was associated with longer disease-free survival (DFS; P = .03), whereas expression of CD138/Syn-1 was associated with shorter DFS (P = .03). OS and DFS were worse in patients with immunophenotypic profiles related to post-germinal center (GC) differentiation (BCL-6 and CD10 negative, MUM1/IRF4 and/or CD138/Syn-1 positive) when compared with GC differentiation (P = .01). When controlled for age-adjusted International Prognostic Index (IPI), prior AIDS-defining illness (ADI), and year of ARL diagnosis, a post-GC differentiation remained significantly associated with poor OS and DFS. Expression of CD10 was associated with a preserved immunocompetence, whereas CD20 was less frequent in patients developing ARL while on highly active antiretroviral therapy (P = .04). In summary, lack of CD20 or CD10 expression and a post-germinal center signature are associated with a worse prognosis in ARL.

Bacteria of the species Chlamydia trachomatis are divided into serovars that are associated with different disease manifestations. Serovars A-C cause trachoma, which occurs mainly in undeveloped countries. Serovars D-K are responsible for oculogenital infections, and serovars L1, L2, and L3 cause lymphogranuloma venereum (LGV). Infections of serovars A-K are usually confined to the mucosal epithelia of the eyes and the anogenital tract. In contrast, the L-serovars are more invasive and may induce genital ulcer or inguinal lymphadenopathy after passing the epithelial surface.1 While serovars D-K are distributed worldwide and represent the most frequent bacterial sexually transmitted disease in Europe and North America, LGV caused by the L-serovars is a very rare …

In the course of 2003, four men were diagnosed with lymphogranuloma venereum (LGV) at the Hamburg Institut für interdiziplinäre Infektiologie und Immunologie. All were men who have sex with men (MSM).

Hodgkin's disease (HD) is the most common non-acquired immunodeficiency syndrome (AIDS)-defining malignancy in human immunodeficiency virus (HIV)-infected patients. We analysed the outcome of patients with HIV-associated HD (HIV-HD) with respect to the use and efficacy of highly active antiretroviral therapy (HAART) and other prognostic factors. To evaluate the effects of several variables on overall survival (OS), Kaplan-Meier statistics and extended Cox regression analysis were performed. Response to HAART was used as a time-dependent variable and was defined as an increase of0.1 x 10(9) CD4 cells/l and/or at least one viral load500 copies/ml during the first 2 years following diagnosis of HIV-HD. Fifty-seven patients with HIV-HD diagnosed between 1990 and 2002 were included in the study. In the Cox model, the only factors independently associated with OS were HAART response [relative hazard (RH) 0.19; 95% confidence interval (CI) 0.06-0.60], complete remission (RH 0.30, 95% CI 0.13-0.72), and ageor=45 years (RH 0.23; 95% CI 0.09-0.60). Median survival time in patients without HAART response was 18.6 months, whereas the median survival time in patients with HAART response was not reached (89% OS at 24 months). In this cohort, a significant improvement in survival was found in patients with HIV-HD who responded to HAART.

AIDS-related lymphoma (ARL) remains a frequent complication of HIV infection. We analyzed the outcome of patients with ARL with respect to the use and efficacy of highly active antiretroviral therapy (HAART) and to potential prognostic factors.This multicenter cohort study included patients with systemic ARL diagnosed between 1990-2001. We evaluated overall survival and the effects of several variables on overall survival using the Kaplan-Meier method and the extended Cox proportional hazards model. Response to HAART was used as a time-dependent variable and was defined as a CD4 cell count increase of/= 100 x 106 cells/l and/or at least one viral load500 copies/ml during the first 2 years following diagnosis of ARL.Among 203 patients with ARL, median overall survival was 9.0 months [95% confidence interval (CI), 7.6-12.4 months]. In the univariate analyses, age60 years, no previous AIDS, CD4 cell counts/= 200 x 106 cells/l, hemoglobin11 g/dl, Ann Arbor stages I-II and A, no extranodal lesion, response to HAART, and complete remission showed statistically significant association with prolonged overall survival. In the multivariate Cox model, the only factors independently associated with overall survival were response to HAART [relative hazard (RH), 0.32; 95% CI, 0.16-0.62], complete remission (RH, 0.24; 95% CI, 0.15-0.36), previous AIDS (RH, 1.92; 95%CI, 1.23-3.01) and extranodal involvement (RH, 2.85; 95% CI, 1.47-5.51).Efficacy of HAART was independently associated with prolonged survival in this large cohort of patients with ARL. Information on patient's response to HAART is crucial for the evaluation of future treatment strategies.

Treatment of Mycosis fungoides (MF) in HIV-infected patients is controversially discoursed. Photodynamic therapy (PDT) after topical sensitization with 5-aminolevulinic acid (5-ALA) is a new and effective modality for treatment of skin malignancies.In this report we describe, what is, to our knowledge, the first case of a patient with MF through advanced HIV-infection, successfully experiencing topical 5-ALA sensitization and PDT.5-ALA ointment was applied to plaques and held in occlusion for 4 hours. PDT was applied using the PDT 1200 irradiation source (Waldmann Medizintechnik System) with 180 J/cm superset 2.Complete remission of MF was achieved, after two completed cycles of photodynamic therapy.MF lesions in the presended case showed a high response to 5-ALA sensitization and PDT. This modality appeared to be very effective in treatment of MF in a HIV-infected patient and could be a valuable treatment option for cutaneous T-cell lymphoma in HIV-infected patients.

Introduction : Little is known about the well-being on long-term exposure to antiretroviral therapy. The ACTG Augmented Symptoms Distress Module (ASDM) is a validated tool which measures the presence of a total of 22 symptoms seen with HIV and quantifies the extent to which they cause distress to the patient. Methods : ELBE was a cross-sectional study that consecutively included adult HIV-infected patients presenting with viral suppression (

Objective: To assess HIV-1 isolate based resistance profiles from extensively pretreated patients and effects of a resistance guided switch of antiretroviral therapy. Methods: In a prospective study phenotypic and genotypic resistance analyses were performed on HIV infected individuals with failure of the current therapy and history of at least three antiretroviral regimens. Antiretroviral therapy was changed according to the results. Viral load and CD4 lymphocyte counts were measured at baseline, after 10 (SD 2), and 24 (2) weeks. Results: All patients (n=52) failed their actual regimen. Currently versus ever previously taking the specific drug, resistance associated mutations and phenotypic resistance to AZT and 3TC were found in over 80% of individuals; resistance to DDI and D4T was detected in less than 10% of cases. A resistance guided switch of therapy was followed by a median decrease of viral load of 0.5 log10 units after 24 weeks. Individuals resistant to two or more drugs compared with patients with resistance to less than two drugs of ongoing treatment, were switched to a regimen containing DDI, D4T, and a PI or NNRTI. After 10 (SD 2) weeks viral load decrease was pronounced in patients with resistance to at least two drugs in the previous regimen. Conclusions: Among different RTI, the profile of clinically relevant resistance indicates pronounced differences when looking at separate drugs. Regarding virological response, in the context of available drugs, resistance tested with currently used methods is of limited value in extensively pretreated patients and seems to have its value primarily in first or second switch of therapy.

Background: Genotypic resistance of Hepatitis B virus (HBV) against lamivudine evolves within months after onset of therapy. Objectives: To determine the longitudinal order in which resistance mutations appear and to compare the kinetics and pathogenicity of wild-type and resistant HBV. Study design: In a longitudinal study, consecutive samples were drawn over a period of 28 months from a patient with chronic hepatitis B, and resistance mutations were followed by sequencing a part of the polymerase region of HBV. These data were compared with HBV copy numbers, HBsAg and ALT levels, and results of consecutive liver biopsies. Results: After 21 weeks of treatment, a silent mutation at codon 528 (CTG to TTG) occurred. Significant genotypic resistance was detectable after 68 weeks, indicated by a substitution of isoleucine for methionine at residue 552 (M552I). Nineteen weeks later, the virus exhibited additional resistance-associated mutations (L528M and I552V). The resulting high-level resistance was reflected by an increase of serum HBV copies of 4.7 log 10 . The turnover of wild-type and resistant HBV was 2.6×10 6 and 1.8×10 6 virions/day, respectively. HBsAg and ALT levels were lower within the period when resistant HBV was detectable. During treatment the progress of liver fibrosis was arrested. Conclusions: The in vivo replicative capacities and dynamics of wild-type and resistant HBV were similar. However, resistant HBV seemed to exhibit reduced pathogenicity.

Die Optionen in der Behandlung der HIV-Infektion haben sich in den letzten Jahren deutlich gebessert. Derzeit sind 14 Substanzen aus den 3 Wirkstoffgruppen Nukleosidale Reverse-Transkriptase-Hemmer (NRTI), Nicht-Nukleosidale Reverse-Transkriptase-Hemmer (NNRTI) und Protease-Hemmer (PI) national oder international zugelassen. Eine moderne antiretrovirale Therapie besteht laut internationalen Empfehlungen aus mindestens 3 Substanzen, wobei eine Kombination aus 2 NRTI plus einem PI oder einem NNRTI als Standard gilt [1]. Durch den Einsatz dieser Therapien kommt es bei den meisten Patienten zu einer Verbesserung der virologischen und immunologischen Parameter. Mehrere Studien haben gezeigt, das die so behandelten Patienten deutlich langer leben und das AIDS–definierende Ereignisse signifikant seltener auftreten [2,3].

To evaluate the impact of different antiretroviral therapies on the prognosis of AIDS patients affected by progressive multifocal leukoencephalopathy (PML).A retrospective analysis of all HIV-infected patients admitted to hospital between 1988 and 1996 found 29 patients (25 men) with histologically or PCR-confirmed PML. Their mean age was 39.3 years. The median CD4 cell count was 40 x 10(6)/l (mean, 106 x 10(6)/l). Six patients had CD4 cell counts200 x 10(6)/l. Fourteen patients never received or stopped antiretroviral therapy following diagnosis (group A), 10 patients were treated with nucleoside analogues alone (group B), and five patients started highly active antiretroviral therapy (HAART) including protease inhibitors (group C).The median survival following the onset of symptoms was 131 days, but differed significantly between the three groups: group A, 127 days; group B, 123 days; group C,500 days (P0.0002 for the difference between group C versus group A and B, stratified log-rank test). As of July 1997, four out of five patients on HAART were still alive 391, 500, 543, and 589 days after diagnosis of PML and have either experienced a resolution of the symptoms (three patients) or had progressed very slowly (one patient). A multivariate analysis using Cox regression found younger age at diagnosis to be the only other variable associated with improved survival (P0.02). CD4 cell count, gender, prior AIDS diagnosis, mode of HIV transmission, and therapy with foscarnet, cytarabine, or interferon-alpha did not affect survival in this cohort (P0.1).This study of a large cohort of patients with confirmed PML indicates that AIDS patients with PML may benefit significantly from HAART. All patients with PML should be offered optimal antiretroviral combination therapy.

Background: Kaposi’s sarcoma (KS) is the most frequent neoplasm in patients with AIDS, responsible for death in about 20–30% of the affected patients. Objective: To determine the frequency of opportunistic infections (OI) and change of CD4+ cell counts in patients with KS treated with chemotherapy compared to a group of matched-pair patients without chemotherapy. Methods: In a prospective study, the clinical courses of 35 HIV-infected patients with KS treated with chemotherapy were compared with 35 matched-pair patients without chemotherapy. Results: During the observation period of 6 months, 11 OI occurred in 10 patients of the chemotherapy group and 5 OI in 5 patients of the control group. With respect to the changes of CD4+ cell counts, no significant differences could be observed. Conclusion: The risk for OI in HIV-infected patients with KS is increased while receiving chemotherapy. This should be reflected upon when chemotherapy is taken into consideration.

Background: HIV infection is a risk factor for the development of Herpes zoster (HZ) and its complications. Prior to antiretroviral therapy (ART), HZ incidence in HIV-infected individuals ranged from 2.9-5.1/100 person-years. There is limited evidence for the impact of ART on HZ occurrence among HIV-infected adults. We analysed the incidence of, and risk factors for, HZ in a large cohort of German HIV-positive patients.Methods: The study population was taken from the German KompNet cohort, a nationwide multicenter HIV cohort study. The study population was defined by age (≥ 18 years), year of first positive HIV diagnosis, CD4 values ± 6 months from HIV diagnosis (t0), and month of HZ diagnosis. Incidences were estimated using a Poisson distribution, and uni- and multivariate Cox proportional Hazard ratio (HR) regression models were fitted to identify risk factors for developing an initial HZ episode. Independent variables were sex, age at HIV diagnosis, route of HIV transmission, ART status, CD4 count before HZ episode, immunosuppressive medication, and mode of data documentation (retrospective or prospective).Results: HZ incidence in the overall study population was 1.2/100 person-years. In a subset of patients for that we were able to examine risk factors the following was observed: We examined 3,757 individuals whose mean age at t0 was 38 years. Of those individuals, 96% were diagnosed with HIV in 1996 or later, with a mean observation time of 5.8 years. HZ episodes (n = 362) were recorded in 326 patients (8.7%), resulting in annual HZ incidences of 1.7/100 person-years overall, and 1.6/100 person-years for initial HZ cases. The main risk factors associated with an initial HZ episode were: not partaking in ART compared with an ART regimen containing a non-nucleoside reverse-transcriptase inhibitor (HR 0.530, p < 0.001) or a protease inhibitor (HR 0.624, p = 0.004); and lower CD4 count by 100 cells/μl (HR 0.918, p=0.001).Conclusions: HZ incidence was 4-11-fold higher than in non HIV-infected individuals, but in our study HZ incidences were lower than in previous studies relating to HIV-positive patients. We showed that ART is an important protective factor for HZ episodes. © 2013 Jansen et al.; licensee BioMed Central Ltd.

Background HIV infection is a risk factor for development of Herpes Zoster (HZ) and its complications. There is limited evidence on the impact of antiretroviral therapy (ART) on the occurrence of HZ among HIV-infected adults. Methods Study population was drawn from the KompNet HIV cohort. Inclusion criteria were: age ≥ 18 years, record of HIV diagnosis date (t0), record of CD4 count available ± 6 months from t0. Patients without month of HZ diagnoses were excluded. Study period was 1.1.1985–1.7.2010. Incidences of all HZ events were estimated assuming Poisson distribution, uni-/multivariate Cox proportional Hazard ratio (HR) regression models were fitted to identify risk factors for a first HZ event. Independent variables were: sex, age at HIV diagnosis, HIV transmission route, ART status, CD4-value before HZ episode, immunosuppressive medication, mode of data documentation (retrospective/prospective). Results Study population comprised 3,757 subjects (86% male, 66% MSM, 3% IVDU, 92% Caucasian), mean age at HIV diagnosis was 38 years, mean observation time was 5.8 years. 362 HZ events were recorded in 326 patients (8.6%), resulting in an HZ incidence of 16.7/1,000 PY overall and 16.1/1,000 PY for first HZ cases. Main risk factors associated with first HZ event were: no ART compared to an ART containing a non-nucleoside reverse-transcriptase inhibitor (NNRTI vs no ART; HR 0.530, p Conclusions According to former studies incidence of HZ in HIV-infected individuals was ∼5 times higher than in the general population. Our study showed ART as important protective associated factor for HZ events. Reasons may be earlier HIV-diagnosis, more recent picturing of ART, and low IVDU proportion in our study.

Wk 24 TRANxITION study data showed patients transitioned from immediate release nevirapine (NVP IR) twice daily (BID) to NVP extended release (NVP XR) once-daily (QD) demonstrated non-inferior efficacy to patients continuing on IR NVP BID. Similar safety was reported for NVP XR and NVP IR in the VERxVE study. Wk 48 efficacy/safety data from TRANxITION study are presented here. Supplement: Abstracts of the Tenth International Congress on Drug Therapy in HIV Infection http://www.biomedcentral.com/content/pdf/1758-2652-13-S4-info.pdf Conference: Tenth International Congress on Drug Therapy in HIV Infection 7-11 November 2010 Glasgow, UK (Published: 8 November 2010) doi:10.1186/1758-2652-13-S4-P45 Cite this article as: Arasteh et al.: 48-week efficacy and safety of transitioning virologically stable HIV-1 patients from nevirapine IR 200 mg BID to nevirapine XR 400 mg QD (TRANxITION). Journal of the International AIDS Society 2010 13(Suppl 4):P45. Full text: PubMed Central: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3113048/

Atazanavir (ATV)-based regimens have demonstrated efficacy and safety in both ARV-naive and -experienced patients. However, few reports have assessed effectiveness beyond 2 years. The aim of this study was to describe the long-term outcomes of ATV/r containing regimens in ARV-experienced patients in a clinical setting. Supplement: Abstracts of the Tenth International Congress on Drug Therapy in HIV Infection http://www.biomedcentral.com/content/pdf/1758-2652-13-S4-info.pdf Conference: Tenth International Congress on Drug Therapy in HIV Infection 7-11 November 2010 Glasgow, UK (Published: 8 November 2010) doi:10.1186/1758-2652-13-S4-P31 Cite this article as: Jansen et al.: Long-term efficacy and safety of atazanavir/ritonavir treatment in a real-life cohort of treatmentexperienced HIV patients. Journal of the International AIDS Society 2010 13 (Suppl 4):P31. Full text: PubMed Central: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3113033/

Background: A one-tablet, once-daily abacavir/lamivudine fixed-dose combination (FDC) has been recently approved to treat HIV-1 infection. Methods: A randomized, open-label, parallel-group, multicenter study to compare the efficacy and safety of the FDC group to the separate entities (SE) group, in combination with tenofovir and a new protease inhibitor or nonnucleoside reverse transcription inhibitor in antiretroviral-experienced adults experiencing virologic failure (VF). Eligible subjects had viral loads >1000 copies/mL with ≤3 nucleoside reverse transcription inhibitor-associated mutations. The primary efficacy end point was time-average changed from baseline (average area under the curve minus baseline) in plasma HIV-1 RNA over 48 weeks. Results: A total of 186 subjects were enrolled. The average area under the curve minus baseline was -1.65 and -1.83 log 10 copies/ mL in the FDC and SE groups, respectively (intention to treat; 95% confidence interval: -0.13, 0.38). Patients in the FDC (50%) and SE groups (47%) achieved viral loads