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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Glaxo Wellcome
• Treatments: Acyclovir; Valacyclovir

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.