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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002404
• Other study ID #: 291A
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: January 24, 2008

Study information

• Verified date: June 1999
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Herpes Simplex
• HIV Infections

Intervention

Drug:
• Valacyclovir hydrochloride

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Glaxo Wellcome