Overview

A Comparative Trial of Valacyclovir Hydrochloride ( 256U87 ) and Acyclovir for the Suppression of Anogenital Herpes Infections in HIV-Infected Patients

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
To determine the safety and efficacy of oral valacyclovir hydrochloride ( 256U87 ) compared to acyclovir in the treatment of recurrent anogenital herpes in HIV-infected patients with CD4 counts = or > 100 cells/mm3.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Glaxo Wellcome
Treatments:
Acyclovir
Valacyclovir
Criteria
Inclusion Criteria

Patients must have:

- HIV infection with CD4 counts = or > 100 cells/mm3.

- Documented culture of anogenital herpes simplex virus (HSV) within the last 5 years.

- History of recurrent anogenital HSV infection, with a recurrence (with or without
culture) within 1 year prior to study.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

- Malabsorption or vomiting that would potentially limit the retention and absorption of
oral therapy.

Concurrent Medication:

Excluded:

- Systemic antiherpes medication.

- Interferon.

Patients with the following prior conditions are excluded:

History of hypersensitivity to acyclovir.