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

Primary Purpose

Herpes Simplex, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Valacyclovir hydrochloride
Sponsored by
Glaxo Wellcome
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Herpes Simplex focused on measuring HIV-1, Antiviral Agents, Herpes Genitalis, Recurrence, DNA, Viral, RNA, Viral, valacyclovir, Herpesvirus 2, Human

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: 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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    November 2, 1999
    Last Updated
    January 24, 2008
    Sponsor
    Glaxo Wellcome
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00002404
    Brief Title
    The Effect of Valacyclovir on the Detection of HIV From Genital Herpes Lesions in HIV-Infected Patients
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 1999
    Overall Recruitment Status
    Completed
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Glaxo Wellcome

    4. Oversight

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Herpes Simplex, HIV Infections
    Keywords
    HIV-1, Antiviral Agents, Herpes Genitalis, Recurrence, DNA, Viral, RNA, Viral, valacyclovir, Herpesvirus 2, Human

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Masking
    Double
    Enrollment
    30 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Valacyclovir hydrochloride

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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: 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.

    12. IPD Sharing Statement

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

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