Characteristics of HIV-1 Serodiscordant Couples Enrolled in a Clinical Trial of Antiretroviral Pre-Exposure Prophylaxis for HIV-1 PreventionReport as inadecuate




Characteristics of HIV-1 Serodiscordant Couples Enrolled in a Clinical Trial of Antiretroviral Pre-Exposure Prophylaxis for HIV-1 Prevention - Download this document for free, or read online. Document in PDF available to download.

Introduction

Stable heterosexual HIV-1 serodiscordant couples in Africa have high HIV-1 transmission rates and are a critical population for evaluation of new HIV-1 prevention strategies. The Partners PrEP Study is a randomized, double-blind, placebo-controlled trial of tenofovir and emtricitabine-tenofovir pre-exposure prophylaxis to decrease HIV-1 acquisition within heterosexual HIV-1 serodiscordant couples. We describe the trial design and characteristics of the study cohort.

Methods

HIV-1 serodiscordant couples, in which the HIV-1 infected partner did not meet national guidelines for initiation of antiretroviral therapy, were enrolled at 9 research sites in Kenya and Uganda. The HIV-1 susceptible partner was randomized to daily oral tenofovir, emtricitabine-tenofovir, or matching placebo with monthly follow-up for 24–36 months.

Results

From July 2008 to November 2010, 7920 HIV-1 serodiscordant couples were screened and 4758 enrolled. For 62% 2966-4758 of enrolled couples, the HIV-1 susceptible partner was male. Median age was 33 years for HIV-1 susceptible and HIV-1 infected partners IQR 28–40 and 26–39 respectively. Most couples 98% were married, with a median duration of partnership of 7.0 years IQR 3.0–14.0 and recent knowledge of their serodiscordant status median 0.4 years IQR 0.1–2.0. During the month prior to enrollment, couples reported a median of 4 sex acts IQR 2–8; 27% reported unprotected sex and 14% of male and 1% of female HIV-1 susceptible partners reported sex with outside partners. Among HIV-1 infected partners, the median plasma HIV-1 level was 3.94 log10 copies-mL IQR 3.31–4.53 and median CD4 count was 496 cells-µL IQR 375–662; the majority 64% had WHO stage 1 HIV-1 disease.

Conclusions

Couples at high risk of HIV-1 transmission were rapidly recruited into the Partners PrEP Study, the largest efficacy trial of oral PrEP. ClinicalTrials.gov NCT00557245



Author: Andrew Mujugira , Jared M. Baeten, Deborah Donnell, Patrick Ndase, Nelly R. Mugo, Linda Barnes, James D. Campbell, Jonathan Wangi

Source: http://plos.srce.hr/



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