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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Herpes Simplex; HIV Infections

Treatments: Drug: Valacyclovir hydrochloride; Drug: Acyclovir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002084

07

104B

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.