A Study of Valacyclovir as Treatment for Genital Herpes Simplex Virus in HIV-Infected Patients
An International, Randomized, Double-Blind, Placebo-Controlled Study of Valacyclovir for the Suppression of Recurrent Ano-Genital HSV Infections in HIV-Infected Subjects
2 other identifiers
interventional
N/A
2 countries
24
Brief Summary
The purpose of this study is to see if valacyclovir (Valtrex) is a safe and effective treatment for ano-genital HSV infections (herpes simplex virus infections of the anus and external genitals) in HIV-infected patients.
Trial Health
Trial Health Score
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24 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 1999
CompletedFirst Submitted
Initial submission to the registry
May 11, 2000
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
July 1, 2001
May 11, 2000
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients may be eligible for this study if they:
- Are at least 18 years old.
- Are HIV-positive.
- Have herpes simplex virus (HSV) 2.
- Have received combination anti-HIV therapy for at least 2 months before entering the study.
- Have had 4 or more recurrences of ano-genital HSV (herpes infection of the anus and genitals) in the last 12 months. (If patient is taking medication to control HSV, then he/she must have had 4 or more recurrences of ano-genital HSV per year before beginning regular anti-HSV therapy, which is defined as therapy of 12 or more weeks.)
- Agree to use effective methods of birth control from 2 weeks before taking study drug, throughout the study, and for 4 weeks after completing the study. (A female may be eligible if not able to have children.)
You may not qualify if:
- Patients will not be eligible for this study if they:
- Have blood vessel disease.
- Are sensitive to acyclovir, Valtrex, famciclovir, or ganciclovir.
- Are unable to take medications by mouth.
- Have non-healed sores on the anus or genitals at beginning of study.
- Are using anti-herpes drugs. To be eligible for enrollment, patients currently using anti-herpes drugs must stop treatment with these drugs at the beginning of the study; however, therapy may be started again if the investigator finds it necessary.
- Are using interferon. Patients receiving interferon must stop interferon before beginning the study.
- Have kidney or liver problems.
- Are pregnant or breast-feeding.
- Have a type of HSV that is resistant to acyclovir, Valtrex, famciclovir, or ganciclovir.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Glaxo Wellcomelead
Study Sites (24)
East Bay AIDS Ctr
Berkeley, California, 94705, United States
Pacific Oaks Research
Beverly Hills, California, 90211, United States
Kraus Med Partners
Los Angeles, California, 90036, United States
ViRx Inc
San Francisco, California, 94109, United States
IDC Research Initiative
Altamonte Springs, Florida, 32701, United States
Healthnet Institute
Fort Lauderdale, Florida, 33316, United States
Univ of Miami School of Medicine
Miami, Florida, 331361013, United States
Treasure Coast Infectious Disease Consultants
Vero Beach, Florida, 32960, United States
Palm Beach Research Ctr
West Palm Beach, Florida, 33409, United States
Indiana Univ School of Medicine / Dept of Infect Dis
Indianapolis, Indiana, 46202, United States
Univ of Minnesota
Minneapolis, Minnesota, 55455, United States
Advanced Biomedical Research Inc
Hackensack, New Jersey, 07601, United States
Nalle Clinic / Clinical Research Dept
Charlotte, North Carolina, 28207, United States
Wake County Dept of Health
Raleigh, North Carolina, 27610, United States
Westover Heights Clinic
Portland, Oregon, 97210, United States
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107, United States
Dr Alvan Fisher
Providence, Rhode Island, 02907, United States
Baylor College of Medicine / Dept of Medicine
Houston, Texas, 770303498, United States
Richmond AIDS Consortium
Richmond, Virginia, 23219, United States
Univ of Washington Virology Research Clinic
Seattle, Washington, 98122, United States
Dr Barbara Romanowski
Edmonton, Alberta, Canada
Sunnybrook Health Science Ctr
Toronto, Ontario, Canada
Clinique Medicale L'Actuele
Montreal, Quebec, Canada
Centre De Recherche En Infectiologie
Ste Foy, Quebec, Canada