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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

Page last updated: August 23, 2015

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