Characteristics of HIV-1 Discordant Couples Enrolled in a Trial of HSV-2 Suppression to Reduce HIV-1 Transmission: The Partners Study

Citation:
"Characteristics of HIV-1 Discordant Couples Enrolled in a Trial of HSV-2 Suppression to Reduce HIV-1 Transmission: The Partners Study."; 2009.

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 CD4
count $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 vaginalis in 14% of HIV-1
infected women. Median baseline CD4 count for HIV-1 infected participants was 462cells/mcL and median HIV-1 plasma
RNA was 4.2 log10 copies/mL. After adjusting for age and African region, correlates of HIV-1 RNA level included male gender
(+0.24 log10 copies/mL; p,0.001) and CD4 count (20.25 and 20.55 log10 copies/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 Africa
at 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-1
transmission.
Trial Registration: ClinicalTrials.gov NCT00194519

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