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

Tracking Information

First Received Date ^ICMJE

January 15, 2004

Last Updated Date

November 3, 2009

Start Date ^ICMJE

April 2005

Primary Completion Date

June 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Serologically confirmed HIV infection [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Serologically confirmed HIV infection

Change History

Complete list of historical versions of study NCT00076232 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Occurrence and frequency of genital ulcers
proportion of doses missed by study participants assigned to twice-daily acyclovir and twice-daily placebo

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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 Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

HIV Infections
HIV Seronegativity
Herpes Genitalis

Intervention ^ICMJE

Drug: Acyclovir
Drug: Acyclovir placebo

Study Arms / Comparison Groups

Experimental: Participants will receive acyclovir for the duration of the study
Placebo Comparator: Participants will receive acyclovir placebo for the duration of the trial

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

3682

Completion Date

November 2007

Primary Completion Date

June 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00076232

Responsible Party

Rona Siskind, DAIDS

Study ID Numbers ^ICMJE

HPTN 039, 1R01 AI52054, 5U01-AI047981-05, DAIDS-ES ID 10066

Study Sponsor ^ICMJE

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators ^ICMJE

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 ^ICMJE

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

Information Provided By

National Institute of Allergy and Infectious Diseases (NIAID)

Verification Date

August 2009

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