Characteristics of HIV-1 discordant couples enrolled in a trial of HSV-2 suppression to reduce HIV-1 transmission: the partners study.
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Lingappa Jairam R, Kahle Erin, Mugo Nelly, Mujugira Andrew, Magaret Amalia, Baeten Jared, Bukusi Elizabeth A, Cohen Craig R, Katabira Elly, Ronald Allan, Kiarie James, Farquhar Carey, Stewart Grace John, Makhema Joseph, Essex M, Were Edwin, Fife Kenneth, Debruyn Guy, Gray Glenda, McIntyre James, Manongi Rachel, Kapiga Saidi, Coetzee David, Allen Susan, Inambao Mubiana, Kayitenkore Kayitesi, Karita Etienne, Kanweka William, Delany Sinead, Rees Helen, Vwalika Bellington, Coombs Robert W, Morrow Rhoda, Whittington William, Corey Lawrence, Wald Anna, Celum Connie, Partners HSV-2/HIV-1 Transmission Study Team
Аннотация
METHODS: HIV-1 serodiscordant heterosexual couples, in which the HIV-1 infected partner was HSV-2 seropositive, had a CD4 count >or=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 log(10) copies/mL. After adjusting for age and African region, correlates of HIV-1 RNA level included male gender (+0.24 log(10) copies/mL; p<0.001) and CD4 count (-0.25 and -0.55 log(10) 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.