Completed

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

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What is being tested

Acyclovir

+ Acyclovir placebo

Drug
Who is being recruted

Blood-Borne Infections+22

+ Urogenital Diseases

+ Genital Diseases

See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-ControlledPhase 3
Interventional
Study Start: April 2005
See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2005

Actual date on which the first participant was enrolled.

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.

Official TitleA 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 
NCT00068965NCT00076232
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

3682 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesAcquired Immunodeficiency SyndromeCommunicable DiseasesDNA Virus InfectionsFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGenital Diseases, MaleHerpes GenitalisHerpes SimplexHerpesviridae InfectionsImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralHIV InfectionsLentivirus InfectionsFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Participants will receive acyclovir for the duration of the study

Group II

Placebo
Participants will receive acyclovir placebo for the duration of the trial

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Suspended

San Francisco Department of Public Health, AIDS Office, Research Section

San Francisco, United StatesSee the location
Suspended

New York Blood Center

New York City, United States
Suspended

University of Washington

Seattle, United States
Completed3 Study Centers