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Home > "T" Clinical Trials Conditions > Treating Genital Herpes to Decrease Risk of HIV Acquisition  Treating Genital Herpes to Decrease Risk of HIV Acquisition
Treating Genital Herpes to Decrease Risk of HIV Acquisition
For Condition: Herpes Genitalis,HIV Infections
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: This study will test whether treating genital herpes decreases the chances of a person getting HIV.
Details: Herpes simplex virus type 2 (HSV-2) is the primary cause of genital ulcers and one of the most prevalent sexually transmitted diseases (STDs) worldwide. Previous studies have shown that 30% to 50% of HIV uninfected gay men are HSV-2 seropositive. Most of these men were asymptomatic and unaware they had HSV-2. Research has shown HSV-2 infection to be a risk factor for HIV acquisition. A recent study of HIV-discordant couples from Rakai, Uganda has shown that at all levels of HIV viral load in the HIV infected partner, HSV-2 infection in the susceptible partner increased the per-contact risk of acquisition of HIV fivefold. Acyclovir is FDA-approved for the treatment of genital herpes. Acyclovir has an acceptable safety profile for widespread STD treatment and is inexpensive and well-tolerated. This study will assess the efficacy of HSV-2 suppression with daily acyclovir on HIV acquisition among men who have sex with men. Participants in this study will be randomly assigned to receive either acyclovir or placebo. Both acyclovir and placebo will be taken twice daily for 12 months. The primary outcome measure will be HIV infection rates.
Eligibility:
Study Type: Interventional, Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Male
Protocol Entry Criteria: Inclusion Criteria - HSV-2 (genital herpes) infection - HIV uninfected - Engaged in anal intercourse, insertive or receptive, with another man within the past 6 months - Not intending to move out of the area for the duration of study participation
Total Enrollment: 4000
Location and Contact Information:
Overall Study Official:
ConnieCelum, Principal Investigator, University of Washington
New York Blood Center *Recruiting*
New York City, New York,
United States
Recruiting Louise Austin 212-388-0008
San Francisco Department of Health *Recruiting*
San Francisco, California,
United States
Recruiting Tim Matheson 415-554-9064
University of Washington *Recruiting*
Seattle, Washington, 98104
United States
Recruiting George Froehle 206-521-5821
Additional Information:
Study ID Numbers: 1R01AI52054;
Study Start Date: November 2003
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00068965
Other Herpes Genitalis Studies:
1. A Study of Valacyclovir as Treatment for Genital Herpes Simplex Virus in HIV-Infected Patients
2. A Clinical Research Study For The Suppression And Treatment Of Genital Herpes Infection in HIV-Infected Persons
3. Treating Genital Herpes to Decrease Risk of HIV Acquisition
Related Studies:
Other Herpes Genitalis Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Treating Genital Herpes to Decrease Risk of HIV Acquisition
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