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

Launched by GLAXO WELLCOME · Aug 30, 2001

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility 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.