Predictive markers of HIV-related weight loss and determination of differences between populations with weight loss stratified by opportunistic processes.
OBJECTIVE
To describe factors predictive of >10% weight loss among enrolled participants in clinical trials of the AIDS Clinical Trial Group (ACTG).


METHODS
A retrospective analysis of data from selected ACTG antiretroviral clinical trials completed prior to 1996 (ACTG 116, 117, 155, 175, and 241), which did not include protease inhibitors.


METHODS
Data were analyzed in Cox proportional hazards models to determine significant predictors for >10% weight loss while on study. Weight loss occurring within 30 days before or after an opportunistic infection (OI) was defined as "OI-associated." Both univariate and multivariate models were considered; gender-specific models were also analyzed to provide insight into potential gender differences in predictors of weight loss.


RESULTS
We found that substantial weight loss is a frequent occurrence among those enrolled in clinical trials of antiretroviral agents; approximately 15% of subjects in the studies considered experienced >10% weight loss. CD4 cell count and HIV-1 RNA at week 8, Karnofsky score, and injection drug use status were significant multivariate predictive markers for weight loss associated with an OI; baseline weight, hemoglobin, triglycerides, and gender were additional predictors for weight loss not associated with an OI.


CONCLUSIONS
This is the first study to characterize the association between baseline viral load and future weight loss. Baseline and week 8 immunologic parameters as well as measures of baseline symptomatology were significant predictors of weight loss associated and not associated with an OI.
Zackin
R A
RA
Department of Biostatistics, Harvard School of Public Health, Boston, Massachusetts 02115, USA. zackin@sdac.harvard.edu
Clark
R A
RA
Currier
J S
JS
Mildvan
D
D
D017088:AIDS-Related Opportunistic Infections / Q000150:complications*; D000293:Adolescent; D000328:Adult; D000368:Aged; D015415:Biomarkers; D002648:Child; D002986:Clinical Trials as Topic; D005260:Female; D015497:HIV-1 / Q000235:genetics; D006801:Humans; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D016016:Proportional Hazards Models; D012367:RNA, Viral / Q000032:analysis; D012189:Retrospective Studies; D019562:Viral Load; D015431:Weight Loss
D015415:Biomarkers; D012367:RNA, Viral