Status:
COMPLETED
A Study of Acyclovir to Help Prevent HIV Infection in People With Genital Herpes
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Drug Abuse (NIDA)
Conditions:
HIV Infections
HIV Seronegativity
Eligibility:
All Genders
Phase:
PHASE3
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 effe...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2007
Estimated Enrollment :
3682 Patients enrolled
Trial Details
Trial ID
NCT00076232
Start Date
April 1 2005
End Date
November 1 2007
Last Update
December 30 2010
Active Locations (3)
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1
San Francisco Department of Public Health, AIDS Office, Research Section
San Francisco, California, United States, 94102
2
New York Blood Center
New York, New York, United States
3
University of Washington
Seattle, Washington, United States, 98104