A Study of Valacyclovir as Treatment for Genital Herpes Simplex Virus in HIV-Infected Patients
- Conditions
- Herpes SimplexHIV InfectionsHerpes Genitalis
- Registration Number
- NCT00005663
- Lead Sponsor
- Glaxo Wellcome
- 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.
- Detailed Description
Patients are randomized in a 2:1 ratio to receive either Valtrex or placebo, twice daily, for up to 6 months. Patients come to the clinic for routine monthly assessments for 6 months, and return to the clinic for evaluation within 24 hours of the first signs or symptoms of an ano-genital HSV recurrence. Once the clinician confirms the presence of at least the macular/papular lesion stage, double-blind suppressive therapy is discontinued and open-label treatment with a higher dose of Valtrex twice daily for 5 days is initiated. For the first recurrence, patients are instructed to return to the clinic for further clinical assessments on Day 5 of the recurrence. Patients who have not healed by Day 5 may be offered an additional five days of open-label treatment, as deemed appropriate by the clinical investigator. If an additional 5-day course of open-label treatment medication is dispensed, the patient returns to the clinic on Day 10 for evaluation. Patients who have not healed by Day 10 are managed as deemed appropriate by the investigator. Once treatment of the first ano-genital HSV recurrence is complete and the patient is healed, patients are switched to open-label suppressive therapy with Valtrex for the remainder of the study period (up to a maximum of 6 months). The total duration of the study for all patients is 6 months.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (24)
Palm Beach Research Ctr
🇺🇸West Palm Beach, Florida, United States
Baylor College of Medicine / Dept of Medicine
🇺🇸Houston, Texas, United States
Advanced Biomedical Research Inc
🇺🇸Hackensack, New Jersey, United States
Dr Barbara Romanowski
🇨🇦Edmonton, Alberta, Canada
Centre De Recherche En Infectiologie
🇨🇦Ste Foy, Quebec, Canada
ViRx Inc
🇺🇸San Francisco, California, United States
Univ of Miami School of Medicine
🇺🇸Miami, Florida, United States
Univ of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Healthnet Institute
🇺🇸Fort Lauderdale, Florida, United States
Dr Alvan Fisher
🇺🇸Providence, Rhode Island, United States
Clinique Medicale L'Actuele
🇨🇦Montreal, Quebec, Canada
Treasure Coast Infectious Disease Consultants
🇺🇸Vero Beach, Florida, United States
Indiana Univ School of Medicine / Dept of Infect Dis
🇺🇸Indianapolis, Indiana, United States
Wake County Dept of Health
🇺🇸Raleigh, North Carolina, United States
Nalle Clinic / Clinical Research Dept
🇺🇸Charlotte, North Carolina, United States
Westover Heights Clinic
🇺🇸Portland, Oregon, United States
Univ of Washington Virology Research Clinic
🇺🇸Seattle, Washington, United States
Richmond AIDS Consortium
🇺🇸Richmond, Virginia, United States
East Bay AIDS Ctr
🇺🇸Berkeley, California, United States
Kraus Med Partners
🇺🇸Los Angeles, California, United States
Pacific Oaks Research
🇺🇸Beverly Hills, California, United States
IDC Research Initiative
🇺🇸Altamonte Springs, Florida, United States
Philadelphia FIGHT
🇺🇸Philadelphia, Pennsylvania, United States
Sunnybrook Health Science Ctr
🇨🇦Toronto, Ontario, Canada