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The Safety and Effectiveness of MK-639 and Zidovudine, Used Alone and Together, in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Indinavir sulfate
Zidovudine
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections

Eligibility Criteria

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

Inclusion Criteria Patients must have: HIV seropositivity. Average CD4 count between 50 and 500 cells/mm3 based on 2 separate pre-study determinations at least 1 week apart. Note: Patients with known hemophilia may be enrolled at the discretion of the investigator. Prior Medication: Excluded: Any protease inhibitor. Significant prior use (greater than 2 weeks) of nucleoside analogues. Chronic therapy for an active opportunistic infection. (Allowed: Prophylaxis with aerosolized pentamidine, trimethoprim/sulfamethoxazole, dapsone, topical antifungals, and isoniazid). Investigational agents or immunomodulators within 30 days prior to study entry. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Acute hepatitis. Lymphoma. Visceral Kaposi's sarcoma. Invasive cervical cancer. Active infection. Concurrent Medication: Excluded: Anticipated immunosuppressive therapy.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    November 2, 1999
    Last Updated
    June 23, 2005
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00002443
    Brief Title
    The Safety and Effectiveness of MK-639 and Zidovudine, Used Alone and Together, in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
    Official Title
    Twelve-Month Study in HIV-1 Seropositive Retroviral-Naive Patients to Compare the Safety and Efficacy of MK-639 and Zidovudine (AZT) Administered Concomitantly to MK-639 Alone and Zidovudine (AZT) Alone
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 1996
    Overall Recruitment Status
    Completed
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    January 1996 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    5. Study Description

    Brief Summary
    To compare the effects on CD4 counts and safety of MK-639 (indinavir, IDV) and AZT administered concomitantly to MK-639 alone and AZT alone in HIV-1 seropositive patients.
    Detailed Description
    Patients are randomized to 1 of 3 groups for 12 months of treatment. Group 1 receives MK-639 plus AZT. Group 2 receives MK-639 alone. Group 3 receives AZT alone. Safety and tolerability are assessed by the incidence of clinical and laboratory adverse experiences. Blood and urine samples are collected for safety assessment and to determine CD4 cell counts and serum viral RNA levels. If therapy with MK-639 alone or with AZT is found to be generally safe and clinically efficacious, patients who have completed the study will have the opportunity to continue in an extension study protocol on a treatment regimen including MK-639.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV Infections

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Indinavir sulfate
    Intervention Type
    Drug
    Intervention Name(s)
    Zidovudine

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria Patients must have: HIV seropositivity. Average CD4 count between 50 and 500 cells/mm3 based on 2 separate pre-study determinations at least 1 week apart. Note: Patients with known hemophilia may be enrolled at the discretion of the investigator. Prior Medication: Excluded: Any protease inhibitor. Significant prior use (greater than 2 weeks) of nucleoside analogues. Chronic therapy for an active opportunistic infection. (Allowed: Prophylaxis with aerosolized pentamidine, trimethoprim/sulfamethoxazole, dapsone, topical antifungals, and isoniazid). Investigational agents or immunomodulators within 30 days prior to study entry. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Acute hepatitis. Lymphoma. Visceral Kaposi's sarcoma. Invasive cervical cancer. Active infection. Concurrent Medication: Excluded: Anticipated immunosuppressive therapy.

    12. IPD Sharing Statement

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    The Safety and Effectiveness of MK-639 and Zidovudine, Used Alone and Together, in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs

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