HIV Infections Clinical Trial
Official title:
A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Acyclovir for the Reduction of HIV Acquisition Among High-Risk HSV-2 Seropositive, HIV Seronegative Individuals
Genital herpes (HSV-2) is the most common cause of genital sores worldwide, and the presence
of genital sores is a significant risk factor for becoming infected with HIV. This study
will test the effectiveness of twice-daily dosing of acyclovir, a commonly prescribed
anti-herpes drug, in preventing HIV infection in HSV-2 infected women who sleep with men
(WSM) and men who sleep with men (MSM).
Study hypothesis: Given that genital herpes is a significant risk factor to HIV acquisition,
twice-daily HSV-2 suppressive therapy - 400 mg of acyclovir - will prevent HIV infection
among high risk, HSV-2 seropositive WSM and MSM.
Many studies have shown that prior HSV-2 infection is associated with an increased risk for
HIV infection. Acyclovir is the most widely studied and clinically utilized antiviral for
the suppression of HSV-2 infection. This study will evaluate the efficacy of twice-daily
dosing of acyclovir in preventing HIV infection in both WSM and MSM with genital herpes. For
this study, WSM will be enrolled in Lusaka, Zambia; Harare, Zimbabwe; and Johannesburg,
South Africa; MSM will be enrolled in Lima and Pucallpa, Peru; Seattle, Washington, USA; New
York City, New York, USA; and San Francisco, California, USA.
Participants will be enrolled for 12 months in this study and will be randomly assigned to
one of two study arms. The first arm will receive 400 mg acyclovir twice daily; the second
arm will receive placebo. Follow-up visits will occur monthly. Participants will be tested
for STDs, including HIV and syphilis, at each visit and treated as necessary; participants
will also be given adherence and condom counseling, risk behavior and sexual history
questionnaires, and genital symptoms questionnaires at all study visits. Medical history
will be assessed and participants will undergo blood work at Months 3, 6, 9, and 12.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention
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