Characteristics of HIV-1 discordant couples enrolled in a trial of HSV-2 suppression to reduce HIV-1 transmission: the partners study

Abstract

Background:The Partners HSV-2/HIV-1 Transmission Study (Partners Study) is a phase III, placebo-controlled trial of daily acyclovir for genital herpes (HSV-2) suppression among HIV-1/HSV-2 co-infected persons to reduce HIV-1 transmission to their HIV-1 susceptible partners, which requires recruitment of HIV-1 serodiscordant heterosexual couples. We describe the baseline characteristics of this cohort.Methods:HIV-1 serodiscordant heterosexual couples, in which the HIV-1 infected partner was HSV-2 seropositive, had a CD4count$250 cells/mcL and was not on antiretroviral therapy, were enrolled at 14 sites in East and Southern Africa.Demographic, behavioral, clinical and laboratory characteristics were assessed.Results:Of the 3408 HIV-1 serodiscordant couples enrolled, 67% of the HIV-1 infected partners were women. Couples had cohabitated for a median of 5 years (range 2–9) with 28% reporting unprotected sex in the month prior to enrollment.Among HIV-1 susceptible participants, 86% of women and 59% of men were HSV-2 seropositive. Other laboratory-diagnosed sexually transmitted infections were uncommon (,5%), except for Trichomonas vaginalisin 14% of HIV-1infected women. Median baseline CD4 count for HIV-1 infected participants was 462cells/mcL and median HIV-1 plasma RNA was 4.2 log10copies/mL. After adjusting for age and African region, correlates of HIV-1 RNA level included male gender(+0.24 log10copies/mL; p,0.001) and CD4 count (20.25 and20.55 log10copies/mL for CD4 350–499 and.500 relative to,350, respectively, p,0.001).Conclusions:The Partners Study successfully enrolled a cohort of 3408 heterosexual HIV-1 serodiscordant couples in Africaat high risk for HIV-1 transmission. Follow-up of this cohort will evaluate the efficacy of acyclovir for HSV-2 suppression in preventing HIV-1 transmission and provide insights into biological and behavioral factors determining heterosexual HIV-1transmission. Trial Registration:Clinical Trials.gov NCT00194519