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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institute on Drug Abuse (NIDA) National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00076232 |
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.
Condition | Intervention | Phase |
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HIV Infections HIV Seronegativity Herpes Genitalis |
Drug: Acyclovir Drug: Acyclovir placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 3682 |
Study Start Date: | April 2005 |
Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Participants will receive acyclovir for the duration of the study
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Drug: Acyclovir
400 mg tablet taken orally twice daily
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2: Placebo Comparator
Participants will receive acyclovir placebo for the duration of the trial
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Drug: Acyclovir placebo
Oral tablet taken twice daily
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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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria For All Participants:
Inclusion Criteria for MSM:
Inclusion Criteria for WSM:
Exclusion Criteria For All Participants:
Exclusion Criteria for MSM:
Exclusion Criteria for WSM:
United States, California | |
San Francisco Department of Public Health, AIDS Office, Research Section | |
San Francisco, California, United States, 94102 | |
United States, New York | |
New York Blood Center | |
New York City, New York, United States | |
United States, Washington | |
University of Washington | |
Seattle, Washington, United States, 98104 |
Study Chair: | Connie Celum, MD, MPH | University of Washington |
Study Chair: | Anna Wald, MD, MPH | University of Washington |
Responsible Party: | DAIDS ( Rona Siskind ) |
Study ID Numbers: | HPTN 039, 1R01 AI52054, 5U01-AI047981-05 |
Study First Received: | January 15, 2004 |
Last Updated: | September 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00076232 |
Health Authority: | United States: Federal Government |
HIV Seronegativity |
Herpes Simplex Sexually Transmitted Diseases, Viral Herpes Genitalis Acquired Immunodeficiency Syndrome Genital Diseases, Male Immunologic Deficiency Syndromes Herpesviridae Infections |
Virus Diseases Genital Diseases, Female Acyclovir HIV Infections Sexually Transmitted Diseases DNA Virus Infections Retroviridae Infections |
Anti-Infective Agents Communicable Diseases RNA Virus Infections Slow Virus Diseases Immune System Diseases |
Therapeutic Uses Lentivirus Infections Infection Antiviral Agents Pharmacologic Actions |