A Study of Valacyclovir as Treatment for Genital Herpes Simplex Virus in HIV-Infected Patients
Herpes Simplex, HIV Infections, Herpes Genitalis
About this trial
This is an interventional treatment trial for Herpes Simplex focused on measuring Herpes Simplex, Antiviral Agents, Anus Diseases, Herpes Genitalis, Recurrence, valacyclovir
Eligibility Criteria
Inclusion Criteria 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.) Exclusion Criteria 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.
Sites / Locations
- East Bay AIDS Ctr
- Pacific Oaks Research
- Kraus Med Partners
- ViRx Inc
- IDC Research Initiative
- Healthnet Institute
- Univ of Miami School of Medicine
- Treasure Coast Infectious Disease Consultants
- Palm Beach Research Ctr
- Indiana Univ School of Medicine / Dept of Infect Dis
- Univ of Minnesota
- Advanced Biomedical Research Inc
- Nalle Clinic / Clinical Research Dept
- Wake County Dept of Health
- Westover Heights Clinic
- Philadelphia FIGHT
- Dr Alvan Fisher
- Baylor College of Medicine / Dept of Medicine
- Richmond AIDS Consortium
- Univ of Washington Virology Research Clinic
- Dr Barbara Romanowski
- Sunnybrook Health Science Ctr
- Clinique Medicale L'Actuele
- Centre De Recherche En Infectiologie