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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

Sponsor
Merck Sharp & Dohme LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT00002443
Collaborator
(none)
780
Enrollment

Study Details

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.

Condition or Disease Intervention/Treatment Phase
N/A

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.

Study Design

Study Type:
Interventional
Masking:
Double
Primary Purpose:
Treatment
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 Completion Date :
Jan 1, 1996

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 0 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Merck Sharp & Dohme LLC

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00002443
    Other Study ID Numbers:
    • 246B
    First Posted:
    Aug 31, 2001
    Last Update Posted:
    Jun 24, 2005
    Last Verified:
    Sep 1, 1996
    Additional relevant MeSH terms:
    HIV Infections
    Zidovudine
    Indinavir

    Study Results

    No Results Posted as of Jun 24, 2005