Herpes Simplex, HIV Infections
Conditions
Keywords
HIV-1, Antiviral Agents, Herpes Genitalis, Recurrence, DNA, Viral, RNA, Viral, valacyclovir, Herpesvirus 2, Human
Brief summary
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.
Detailed 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.
Interventions
Sponsors
Glaxo Wellcome
Study design
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed