A Study of Valacyclovir as Treatment for Genital Herpes Simplex Virus in HIV-Infected Patients

Status unconfirmed · Phase 3

Conditions studied: Herpes Simplex, HIV Infections, Herpes Genitalis

In brief

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.

Key facts

Study ID

NCT00005663

Run by

Glaxo Wellcome

Starts

1999-06-01

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• East Bay AIDS Ctr — Berkeley, California, United States
• Pacific Oaks Research — Beverly Hills, California, United States
• Kraus Med Partners — Los Angeles, California, United States
• ViRx Inc — San Francisco, California, United States
• IDC Research Initiative — Altamonte Springs, Florida, United States
• Healthnet Institute — Fort Lauderdale, Florida, United States
• Univ of Miami School of Medicine — Miami, Florida, United States
• Treasure Coast Infectious Disease Consultants — Vero Beach, Florida, United States
• Palm Beach Research Ctr — West Palm Beach, Florida, United States
• Indiana Univ School of Medicine / Dept of Infect Dis — Indianapolis, Indiana, United States
• Univ of Minnesota — Minneapolis, Minnesota, United States
• Advanced Biomedical Research Inc — Hackensack, New Jersey, United States
• Nalle Clinic / Clinical Research Dept — Charlotte, North Carolina, United States
• Wake County Dept of Health — Raleigh, North Carolina, United States
• Westover Heights Clinic — Portland, Oregon, United States
• Philadelphia FIGHT — Philadelphia, Pennsylvania, United States
• Dr Alvan Fisher — Providence, Rhode Island, United States
• Baylor College of Medicine / Dept of Medicine — Houston, Texas, United States
• Richmond AIDS Consortium — Richmond, Virginia, United States
• Univ of Washington Virology Research Clinic — Seattle, Washington, 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

Full record on ClinicalTrials.gov

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