A Study of Acyclovir to Help Prevent HIV Infection in People With Genital Herpes

Phase 3

Completed

• Conditions: HIV Infections; Herpes Genitalis; HIV Seronegativity
• Interventions: Drug: Acyclovir; Drug: Acyclovir placebo

• Registration Number: NCT00076232
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2004-01-15
• Study First Submitted QC: 2004-01-15
• Study First Posted: 2004-01-16
• Study Start: 2005-04
• Primary Completion: 2007-06
• Study Completion: 2007-11
• Status Verified: 2009-08
• Last Update Submitted: 2010-12-29
• Last Update Posted: 2010-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3682

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Acyclovir	Participants will receive acyclovir for the duration of the study
2	Acyclovir placebo	Participants will receive acyclovir placebo for the duration of the trial

Primary Outcome Measures

Name	Time	Method
Serologically confirmed HIV infection	Throughout study

Secondary Outcome Measures

Name	Time	Method
Proportion of doses missed by study participants assigned to twice-daily acyclovir and twice-daily placebo	Throughout study
Occurrence and frequency of genital ulcers	Throughout study

Trial Locations

Locations (3)

University of Washington; 🇺🇸 Seattle, Washington, United States

San Francisco Department of Public Health, AIDS Office, Research Section; 🇺🇸 San Francisco, California, United States

New York Blood Center; 🇺🇸 New York City, New York, United States