The Effect of Valacyclovir on the Detection of HIV From Genital Herpes Lesions in HIV-Infected Patients
Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Herpes Simplex; HIV Infections
Intervention: Valacyclovir hydrochloride (Drug)
Phase: N/A
Status: Completed
Sponsored by: Glaxo Wellcome
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.
Clinical Details
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
Study design: Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Last updated: January 24, 2008
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