A Study of Acyclovir to Help Prevent HIV Infection in People With Genital Herpes
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Purpose
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 |
|---|---|---|
|
HIV Infections HIV Seronegativity Herpes Genitalis |
Drug: Acyclovir Drug: Acyclovir placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Prevention |
| 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 |
- Serologically confirmed HIV infection [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Occurrence and frequency of genital ulcers [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
- Proportion of doses missed by study participants assigned to twice-daily acyclovir and twice-daily placebo [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 3682 |
| Study Start Date: | April 2005 |
| Study Completion Date: | November 2007 |
| Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Participants will receive acyclovir for the duration of the study
|
Drug: Acyclovir
400 mg tablet taken orally twice daily
|
|
Placebo Comparator: 2
Participants will receive acyclovir placebo for the duration of the trial
|
Drug: Acyclovir placebo
Oral tablet taken twice daily
|
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria For All Participants:
- HIV-uninfected
- HSV-2 infected
- Plans to stay in the area for the duration of study participation
- Willing and able to provide consent, undergo clinical evaluations, take study drugs, adhere to follow-up schedule, and provide adequate locator information
Inclusion Criteria for MSM:
- At least 1 episode of anal intercourse with another man within 6 months of study entry
Inclusion Criteria for WSM:
- At least 1 episode of unprotected vaginal sex within 6 months of study entry
Exclusion Criteria For All Participants:
- Current enrollment in another HIV vaccine or prevention trial
- History of adverse reaction to acyclovir
- Current or planned use of famiciclovir, valacyclovir, or acyclovir for genital HSV. Use of short-course antiviral therapy for herpes zoster after enrollment is allowed.
- Known plans for travel away from study site for more than 2 months
Exclusion Criteria for MSM:
- In a mutually monogamous relationship with an HIV uninfected partner throughout the past 2 years
- Reported sex at birth as female
Exclusion Criteria for WSM:
- Pregnancy at screening or enrollment
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00076232
| 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 |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Rona Siskind, DAIDS |
| ClinicalTrials.gov Identifier: | NCT00076232 History of Changes |
| Obsolete Identifiers: | NCT00068965 |
| Other Study ID Numbers: | HPTN 039, 1R01 AI52054, 5U01-AI047981-05, DAIDS-ES ID 10066 |
| Study First Received: | January 15, 2004 |
| Last Updated: | December 29, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
HIV Seronegativity |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome HIV Infections Infection Immune System Diseases Immunologic Deficiency Syndromes Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases |
Sexually Transmitted Diseases, Viral Slow Virus Diseases Virus Diseases Acyclovir Anti-Infective Agents Antiviral Agents Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on March 02, 2015