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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

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

Information provided by (Responsible Party)
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier
NCT00076232

First received: January 15, 2004
Last updated: December 29, 2010
Last Verified: August 2009
History of Changes
Purpose

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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
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

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures

  • Serologically confirmed HIV infection [ Time Frame: Throughout study ]
Secondary Outcome Measures:
  • Occurrence and frequency of genital ulcers [ Time Frame: Throughout study ]
  • Proportion of doses missed by study participants assigned to twice-daily acyclovir and twice-daily placebo [ Time Frame: Throughout study ]

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

Eligibility

Ages Eligible for Study: Child, Adult, Senior  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00076232

Locations

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

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)

Investigators

Study Chair: Connie Celum, MD, MPH University of Washington
Study Chair: Anna Wald, MD, MPH University of Washington
More Information

More Information


Responsible Party: Rona Siskind, DAIDS  
ClinicalTrials.gov Identifier: NCT00076232   History of Changes  
Other Study ID Numbers: HPTN 039  
  1R01AI052054  
  5U01AI047981-05  
  DAIDS-ES ID 10066  
Study First Received: January 15, 2004  
Last Updated: December 29, 2010  

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

HIV Seronegativity

Additional relevant MeSH terms:
Infection
HIV Infections
Acquired Immunodeficiency Syndrome
Herpes Genitalis
Acyclovir

ClinicalTrials.gov processed this data on October 23, 2017
This information is provided by ClinicalTrials.gov.