Abstract
Objective: To determine factors predictive of >10% weight loss among subjects enrolled on selected ACTG clinical trials. Methods: Data from selected completed ACTG antiretroviral clinical trials (ACTG 116, 117, 155, 175, and 241) were analyzed in Cox proportional hazards models to determine significant predictors for >10% weight loss while on study. Weight loss occurring within 30 days of (before or after) an opportunistic infection (OI) was defined as "OI associated". Results: The cumulative risk for >10% weight loss at 12 and 24 months among the entire cohort (n=5454) was 10.6% (4.0% OI associated) and 21.0% (7.5% OI associated), respectively. Multivariate models for the endpoint of >10% weight loss are shown below: Covariate Entire cohort OI associated Non-OI assoc. HIV-1 RNA(wk8) 1.45 (1.16-1.81) 2.09 (1.37-3.18) 1,41 (1.13-1.77) CD4(wk8) 0.90 (0.83-0.97) 0.80 (0.69-0.93) ns Karnofsky(wk0) 0.74 (0.62-0.87) 0.62 (0.50-0.78) ns Conclusions: Substantial weight loss is a frequent process among subjects enrolled on clinical trials of antiretroviral agents. HIV-1 RNA at baseline and Week 8 were significant univariate predictive markers for weight loss associated or not associated with an OI; Week 8 value was significant in a multivariate model (risk increased 45% for each log increment). Week 8 CD4 count (risk decreased 10% for each 50 cells increment) and baseline Karnofsky score (risk decreased 16% for each 10 points) were additional predictors of OI-associated weight loss.
| Original language | English |
|---|---|
| Pages (from-to) | 457 |
| Number of pages | 1 |
| Journal | Clinical Infectious Diseases |
| Volume | 25 |
| Issue number | 2 |
| State | Published - 1997 |