The Effect of Valacyclovir on the Detection of HIV From Genital Herpes Lesions in HIV-Infected Patients

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Herpes Simplex; HIV Infections

Treatments: Drug: Valacyclovir hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002404

291A

Details and patient eligibility

About

The purpose of this study is to see if valacyclovir affects the detection of HIV in genital herpes lesions in HIV-infected patients. Valacyclovir is used to treat recurrent genital herpes.

Full description

Following evaluation for 2 consecutive episodes of genital herpes in this double-blind, crossover study, 30 HIV-1 positive patients are randomized to receive either valacyclovir or placebo.

All patients are treated for 10 days.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Patients must have:

• Serologically documented HSV-2 and HIV-1 infection.
• History of recurrent genital herpes that presents at least 3 recurrences within the 12 months prior to the start of study.
• No contraindications to valacyclovir.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

1. Hepatic impairment.
2. Impaired renal function (creatinine above 2 mg/dl).
3. Malabsorption syndrome or other gastrointestinal dysfunction.
4. Any other condition that in the investigator's opinion would interfere with study procedures or successful completion of protocol.

Patients with the following prior conditions are excluded:

History of hypersensitivity to acyclovir or valacyclovir.

Prior Medication:

Excluded:

• Participation in any investigational drug trial within 1 month prior to entry on study.

• Systemic anti-HSV therapy within 7 days prior to start of study drug.

  1. Probenecid.

• Suppressive treatment with medication that has anti-HSV activity.

Required:

• Stable antiretroviral therapy or no therapy for at least 1 month.