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

ClinicalTrials.gov Identifier:
NCT00076232
First received: January 15, 2004
Last updated: December 29, 2010
Last verified: August 2009

January 15, 2004
December 29, 2010
April 2005
June 2007   (final data collection date for primary outcome measure)
Serologically confirmed HIV infection [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Serologically confirmed HIV infection
Complete list of historical versions of study NCT00076232 on ClinicalTrials.gov Archive Site
  • Occurrence and frequency of genital ulcers [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
  • Proportion of doses missed by study participants assigned to twice-daily acyclovir and twice-daily placebo [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Occurrence and frequency of genital ulcers
  • proportion of doses missed by study participants assigned to twice-daily acyclovir and twice-daily placebo
Not Provided
Not Provided
 
A Study of Acyclovir to Help Prevent HIV Infection in People With Genital Herpes
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
  • HIV Infections
  • HIV Seronegativity
  • Herpes Genitalis
  • Drug: Acyclovir
    400 mg tablet taken orally twice daily
  • Drug: Acyclovir placebo
    Oral tablet taken twice daily
  • Experimental: 1
    Participants will receive acyclovir for the duration of the study
    Intervention: Drug: Acyclovir
  • Placebo Comparator: 2
    Participants will receive acyclovir placebo for the duration of the trial
    Intervention: Drug: Acyclovir placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3682
November 2007
June 2007   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00076232
HPTN 039, 1R01 AI52054, 5U01-AI047981-05, DAIDS-ES ID 10066
Not Provided
Rona Siskind, DAIDS
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)
Study Chair: Connie Celum, MD, MPH University of Washington
Study Chair: Anna Wald, MD, MPH University of Washington
National Institute of Allergy and Infectious Diseases (NIAID)
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP