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

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. Identifier: NCT00002404
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : January 29, 2008
Information provided by:
NIH AIDS Clinical Trials Information Service

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.

Condition or disease Intervention/treatment Phase
Herpes Simplex HIV Infections Drug: Valacyclovir hydrochloride Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Masking: Double
Primary Purpose: Treatment
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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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:


  • 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.


- Stable antiretroviral therapy or no therapy for at least 1 month. Identifier: NCT00002404     History of Changes
Other Study ID Numbers: 291A
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: January 29, 2008
Last Verified: June 1999

Keywords provided by NIH AIDS Clinical Trials Information Service:
Antiviral Agents
Herpes Genitalis
DNA, Viral
RNA, Viral
Herpesvirus 2, Human

Additional relevant MeSH terms:
HIV Infections
Herpes Simplex
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Herpesviridae Infections
DNA Virus Infections
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Antiviral Agents
Anti-Infective Agents