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02344 MULTIVARIATE ANALYSIS OF RISK FACTORS FOR HIV SEROCONVERSION IN THE COL-1492 PHASE III TRIAL Alary, Michel* Objective: To assess risk factors (including treatment arm) for HIV seroconversion among female sex workers (FSWs) participating in the COL-1492 microbicide phase III trial. Methods: FSWs were recruited and followed monthly from 1996 to 2000 in Benin, Côte dIvoire, South Africa and Thailand. They were randomly allocated to receive either the COL-1492 gel or a placebo. At each visit, a questionnaire was administered and samples collected for HIV and STI testing. Multivariate analysis used a Cox proportional hazard model with time dependent covariates. Results: The overall HIV incidence among 765 women followed for 837.5 person-years (PY) was 12.4 per 100 PY. Independent risk factors for HIV seroconversion were: inconsistent condom use with clients [Hazard ratio (HR): 1.8, 95% confidence interval (95%CI): 1.2-2.7); gonorrhea (HR: 2.4, 95%CI: 1.3-4.3); and being in the COL-1492 treatment arm (HR: 1.6, 95%CI: 1.1-2.4). Conclusions: The association between COL-1492 and HIV acquisition is similar to that of the intention-to-treat analysis. Results on condom use and gonorrhea underline the effectiveness of condoms as a protective device as well as the importance of STI control in HIV prevention. Dr. Michel Alary |
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