Official Title: “The Effect of Treatment With Valacyclovir 500 mg BID on the Detection of HIV From Genital HSV Lesions in HIV-Infected Patients: A Double-Blind Crossover Study”

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.

Study Type: Interventional

Study Design: Treatment, Double-Blind, Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: Valacyclovir hydrochloride

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Glaxo Wellcome

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00002404

Study ID Number: 291A

ClinicalTrials.gov Identifier: NCT00002404

Health Authority: United States: Food and Drug Administration