We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002404
First Posted: August 31, 2001
Last Update Posted: January 29, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NIH AIDS Clinical Trials Information Service
November 2, 1999
August 31, 2001
January 29, 2008
Not Provided
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00002404 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Effect of Valacyclovir on the Detection of HIV From Genital Herpes Lesions in HIV-Infected Patients
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
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.

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.

Interventional
Not Provided
Masking: Double
Primary Purpose: Treatment
  • Herpes Simplex
  • HIV Infections
Drug: Valacyclovir hydrochloride
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
Not Provided
Not Provided

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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00002404
291A
Not Provided
Not Provided
Not Provided
Not Provided
Glaxo Wellcome
Not Provided
Not Provided
NIH AIDS Clinical Trials Information Service
June 1999

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP