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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Glaxo Wellcome


Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier
NCT00002404

First received: November 2, 1999
Last updated: January 24, 2008
Last Verified: June 1999
History of Changes
Purpose

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

Study Type: Interventional
Study Design: 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

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

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

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
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: ~#o1~ Hepatic impairment.
  • Impaired renal function (creatinine above 2 mg/dl).
  • Malabsorption syndrome or other gastrointestinal dysfunction.
  • 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

    Contacts and Locations

    Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

    Please refer to this study by its ClinicalTrials.gov identifier: NCT00002404

    Sponsors and Collaborators

    Glaxo Wellcome
    More Information

    More Information


    Responsible Party: Glaxo Wellcome  
    ClinicalTrials.gov Identifier: NCT00002404   History of Changes  
    Other Study ID Numbers: 291A  
    Study First Received: November 2, 1999  
    Last Updated: January 24, 2008  

    Keywords provided by NIH AIDS Clinical Trials Information Service:

    HIV-1
    Antiviral Agents
    Herpes Genitalis
    Recurrence
    DNA, Viral
    RNA, Viral
    valacyclovir
    Herpesvirus 2, Human

    Additional relevant MeSH terms:
    HIV Infections
    Herpes Simplex
    Valacyclovir
    Acyclovir

    ClinicalTrials.gov processed this data on October 20, 2017
    This information is provided by ClinicalTrials.gov.