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

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ClinicalTrials.gov Identifier: NCT00076232
Recruitment Status : Completed
First Posted : January 16, 2004
Last Update Posted : December 30, 2010
Sponsor:
Collaborators:
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:
National Institute of Allergy and Infectious Diseases (NIAID)

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 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 or disease Intervention/treatment Phase
HIV Infections HIV Seronegativity Herpes Genitalis Drug: Acyclovir Drug: Acyclovir placebo Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3682 participants
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
Study Start Date : April 2005
Actual Primary Completion Date : June 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Serologically confirmed HIV infection [ Time Frame: Throughout study ]

Secondary Outcome Measures :
  1. Occurrence and frequency of genital ulcers [ Time Frame: Throughout study ]
  2. Proportion of doses missed by study participants assigned to twice-daily acyclovir and twice-daily placebo [ Time Frame: Throughout study ]

Eligibility Criteria
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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Other Publications:

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
1R01AI052054 ( U.S. NIH Grant/Contract )
5U01AI047981-05 ( U.S. NIH Grant/Contract )
DAIDS-ES ID 10066
First Posted: January 16, 2004    Key Record Dates
Last Update Posted: December 30, 2010
Last Verified: August 2009

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
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
 Immune System Diseases
Slow Virus Diseases
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Genital Diseases, Male
Genital Diseases, Female
Acyclovir
Antiviral Agents
Anti-Infective Agents