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

December 29, 2010 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

3682

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94102
        • San Francisco Department of Public Health, AIDS Office, Research Section
    • New York
      • New York City, New York, United States
        • New York Blood Center
    • Washington
      • Seattle, Washington, United States, 98104
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serologically confirmed HIV infection
Time Frame: Throughout study
Throughout study

Secondary Outcome Measures

Outcome Measure
Time Frame
Occurrence and frequency of genital ulcers
Time Frame: Throughout study
Throughout study
Proportion of doses missed by study participants assigned to twice-daily acyclovir and twice-daily placebo
Time Frame: Throughout study
Throughout study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

National Institute on Drug Abuse (NIDA)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Mental Health (NIMH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

January 15, 2004

First Submitted That Met QC Criteria

January 15, 2004

First Posted (Estimate)

January 16, 2004

Study Record Updates

Last Update Posted (Estimate)

December 30, 2010

Last Update Submitted That Met QC Criteria

December 29, 2010

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HPTN 039
  • 1R01AI052054 (U.S. NIH Grant/Contract)
  • 5U01AI047981-05 (U.S. NIH Grant/Contract)
  • DAIDS-ES ID 10066

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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