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The Effect of Valacyclovir on the Detection of HIV From Genital Herpes Lesions in HIV-Infected Patients
This study has been completed.
First Received: November 2, 1999   Last Updated: January 24, 2008   History of Changes
Sponsored by: Glaxo Wellcome
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002404
  Purpose

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 Intervention
Herpes Simplex
HIV Infections
Drug: Valacyclovir hydrochloride

MedlinePlus related topics: AIDS Herpes Simplex
Drug Information available for: Valaciclovir Valacyclovir hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Double-Blind, Efficacy Study
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

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 30
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Study ID Numbers: 291A
Study First Received: November 2, 1999
Last Updated: January 24, 2008
ClinicalTrials.gov Identifier: NCT00002404     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
HIV-1
Antiviral Agents
Herpes Genitalis
Recurrence
DNA, Viral
RNA, Viral
valacyclovir
Herpesvirus 2, Human

Study placed in the following topic categories:
Herpes Simplex
Sexually Transmitted Diseases, Viral
Skin Diseases
Herpes Genitalis
Acquired Immunodeficiency Syndrome
Antiviral Agents
Recurrence
Immunologic Deficiency Syndromes
Herpesviridae Infections
Valacyclovir
Virus Diseases
Skin Diseases, Infectious
Acyclovir
HIV Infections
Sexually Transmitted Diseases
DNA Virus Infections
Retroviridae Infections

Additional relevant MeSH terms:
Herpes Simplex
Anti-Infective Agents
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Skin Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Infection
Antiviral Agents
Pharmacologic Actions
Immunologic Deficiency Syndromes
Herpesviridae Infections
Valacyclovir
Skin Diseases, Viral
Virus Diseases
Skin Diseases, Infectious
Acyclovir
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
DNA Virus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on May 07, 2009