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Objectives: To assess temporal trends in the rates of hospitalizations and associated diagnoses among HIV-infected patients before and during the era of highly active antiretroviral therapy., Design: A prospective cohort study of 7155 patients enrolled in the HIV Outpatient Study at 10 US HIV clinics., Methods: We evaluated rates of hospitalizations for major categories of medical conditions during 1994-2005 and modeled trends in these rates using multivariable Poisson regression models for repeated observations. We assessed patient characteristics associated with hospitalization using multiple logistic regression., Results: The rates of hospitalizations (per 100 person-years) fell from 24.6 in 1994 to 11.8 in 2005 (P < 0.0001). The rates of hospitalizations for AIDS opportunistic infections decreased from 7.6 in 1994-1996 to 1.0 in 2003-2005 (P < 0.0001). AIDS opportunistic infections were present at 31% of hospitalizations in 1994-1996 versus 9.5% in 2003-2005, and chronic end-organ disease conditions were present at 7.2% of such hospitalizations in 1994-1996 versus 14.3% in 2003-2005. Mean CD4+ cell count at hospitalization increased from 115 cells/mul in 1994 to 310 cells/mul in 2005. Factors independently associated with hospitalization in the highly active antiretroviral therapy era (1997-2005) included older age, history of substance abuse, lower CD4+ cell count, history of AIDS, and public health insurance., Conclusion: The rates of hospitalizations for HIV-infected patients declined substantially during 1994-2005, due mainly to reductions in the AIDS opportunistic infections. Compared with the period 1994-1997, patients in the highly active antiretroviral therapy era were hospitalized with higher CD4+ cell counts and more frequently for chronic end-organ conditions.

Objective: Renal disease is an increasingly common manifestation among HIV-positive persons, particularly during late stages of HIV disease. We performed a cohort-based, nested case-control study to examine the role of several factors in developing HIV-related chronic renal disease, including HIV viral load and CD4+ cell count., Design: Incident cases of chronic renal disease were identified from a cohort of 6361 prospectively followed HIV-1 positive persons. Controls were selected using incidence density sampling and matched 4:1 on age, race/ethnicity, and gender., Methods: Odds ratios (OR) and 95% confidence intervals (CI) were obtained using conditional logistic regression., Results: One hundred and eight cases of chronic renal disease were identified; 80 (74.1%) were eligible for the current analysis. Nadir CD4+ cell count < 200 x 10(6) cells/l (OR = 4.3; 95% CI, 2.1-8.7), highly active antiretroviral therapy (HAART) use for 56 days or more (OR = 0.5; 95% CI, 0.3-1.0), and hypertension [treated with angiotensin-converting enzyme (ACE) inhibitors: OR = 4.6; 95% CI, 1.8-11.6; treated with non-ACE inhibitors: OR = 2.5; 95% CI, 1.0-6.2; not treated: OR = 4.2; 95% CI, 0.8-21.6] were associated with disease. HAART use for 56 days or more modified the associations for nadir CD4+ cell count and hypertension., Conclusions: Our findings suggest that advanced HIV-disease, as indicated by low CD4+ cell count, is associated with subsequently developing chronic renal disease and treatment with HAART may reduce the risk of developing chronic renal disease.

Objective: To examine the prevalence and clinical correlates of subsequently measurable viremia in HIV-infected patients who have achieved viral suppression below the limits of quantification (< 50 copies/ml)., Design: Non-randomized dynamic cohort study of ambulatory HIV patients in nine HIV clinics in eight cities., Patients: Patients had two consecutive HIV-1 RNA levels < 50 copies/ml (minimum, 2 months apart) that were followed by at least two more viral level determinations while remaining on the same antiretroviral therapy (ART) between January 1997 and June 2000 (median 485 days). Transiently viremic patients were defined having a subsequently measurable viremia but again achieved suppression < 50 copies/ml., Results: Of the 448 patients, 122 (27.2%) had transient viremia, 19 (4.2%) had lasting low-level viremia and 33 (7.4%) had lasting high-level viremia (defined as 50-400 and > 400 copies/ml, respectively). Only 16 (13.1%) of those who had transient viremia later had persistent viremia > 50 copies/ml. The occurrence of transient viremia did not vary with whether the patient was ART-naive or experienced (P = 0.31), or currently taking protease inhibitors or not (P = 0.08). On consistent ART, the median percentage increase in CD4 cell count was statistically different between subgroups of our cohort (Kruskal-Wallis, P = 0.002)., Conclusions: Transiently detectable viremia, usually 50-400 copies/ml, was frequent among patients who had two consecutive HIV-1 RNA levels below the limits of quantification. In this analysis, such viremia did not appear to affect the risk of developing lasting viremia. Caution is warranted before considering a regimen as 'failing' and changing medications., (Copyright 2002 Lippincott Williams & Wilkins)

Objective: To evaluate the durability and correlates of the effectiveness of highly active antiretroviral therapy (HAART) in terms of AIDS-related mortality and morbidity, HIV viremia, and CD4 cell count., Design and Setting: The HIV Outpatient Study (HOPS), a prospective observational cohort from eight clinics in the USA that has been running since 1994., Participants: Mortality and opportunistic infection (OI) rates were calculated for 1769 HOPS patients with CD4 cell count ever < 100 x 106/l. Data from 1022 HAART recipients with CD4 cell count ever < 500 x 106/l were analyzed., Main Outcome Measures: Mortality and AIDS-related OI rates. Treatment success was defined as a reduction in plasma HIV RNA copies/ml of 1.0 log10 or more, or to an undetectable level, with a stable or rising CD4 cell count. Durable success was a successful response lasting at least 12 consecutive months., Results: HAART use remained high; mortality and OIs low. Patients received a mean of 1.8 HAART regimens. Median time on first HAART (n = 1022) was 11.8 months; second HAART (n = 424) 7.4 months; and third HAART (n = 213) 7.2 months. Treatment success was most likely for pre-HAART treatment naive patients; durably successful first HAART most often contained one protease inhibitor, particularly indinavir or nelfinavir (P = 0.006, adjusted for prior antiretroviral therapy). Durable success was most likely with first (49.0%) than with second (29.6%, P = 0.013) or third or more HAART regimens (14.9%, P < 0.0001). Time to success with first HAART was shorter for durable than non-durable responders (3.6 versus 5.3 months, respectively; unadjusted P = 0.002)., Conclusions: Durable response to HAART was associated with being pre-HAART therapy naive, prompt response to HAART, and single protease inhibitor-based initial HAART (indinavir or nelfinavir). Sequential HAART regimens were of progressively shorter duration, demonstrated less viral suppression and CD4 cell count benefit, yet low morbidity and mortality rates were sustained.

Objective: To identify clinical factors associated with prevalence of fat atrophy (lipoatrophy) and fat accumulation (lipoaccumulation) in HIV-1 infected patients., Design: Evaluation of HIV-1 infected patients seen for routine care between 1 October and 31 December 1998 in the eight HIV Outpatient Study (HOPS) clinics., Setting: Eight clinics specializing in the care of HIV-1 infected patients., Patients: A total of 1077 patients were evaluated for signs of fat maldistribution., Interventions: A standardized set of questions and specific clinical signs were assessed. Demographic, clinical and pharmacological data for each patient were also included in the analysis., Main Outcome Measures: Demographic, immunologic, virologic, clinical, laboratory, and drug treatment factors were assessed in stratified and multivariate analyses for their relationship to the presence and severity of fat accumulation and atrophy., Results: Independent factors for moderate/severe lipoatrophy for 171 patients were increasing age, any use of stavudine, use of indinavir for longer than 2 years, body mass index (BMI) loss, and measures of duration and severity of HIV disease. Independent risk factors for moderate/severe fat accumulation for 104 patients were increasing age, BMI gain, measures of amount and duration of immune recovery, and duration of antiretroviral therapy (ART). The number of non-drug risk factors substantially increased the likelihood of lipoatrophy. If non-drug risk factors were absent, lipoatrophy was unusual regardless of the duration of drug use., Conclusions: HIV-associated lipodystrophy is associated with several host, disease, and drug factors. While prevalence of lipoatrophy increased with the use of stavudine and indinavir, and lipoaccumulation was associated with duration of ART, other non-drug factors were strongly associated with both fat atrophy and accumulation.

Objectives: To assess the characteristics of medication regimen modification and the influence of a commercial genotypic resistance assay on the short-term (3-12 weeks) viral load response (> or = 0.5 log reduction) in HIV-1-infected patients extensively treated with antiretroviral therapy (ART)., Methods: A nested cohort study was performed in two clinics from the HIV Outpatient Study of 96 persons with a HIV-1 viral load of 10(4) log copies/ml or greater taking at least two antiretroviral medications., Results: Successful modification was associated with adding at least two new medications [relative risk (RR), 1.5; 95% confidence interval (CI), 1.1-2.2], adding a drug from a previously unused class of agents (RR, 2.0; CI, 1.4-2.9), the initiation of a non-nucleoside reverse transcriptase inhibitor (NNRTI) (RR, 1.7; CI, 1.2-2.4), but not substituting a protease inhibitor or the use of a commercial genotypic resistance assay., Conclusion: Incorporating a drug from a previously unused class or changing at least two new medications, but, within the confines of this study, not using a commercial genotypic resistance assay, was associated with the successful modification of ART as measured by a reduction in viral load.