Overview

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.