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A Study of MKC-442 in HIV-Positive Patients

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Emivirine
Sponsored by
Triangle Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Anti-HIV Agents, Viral Load, MKC 442

Eligibility Criteria

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

Inclusion Criteria Concurrent Medication: Allowed: Based on medical history, medical condition, prior use of antiretroviral drugs, and genotypic analysis of the predominant strain of HIV-1 isolated from plasma, administration of at least 2 available antiviral agents by prescription may be given with MKC-422. Patients must have: - HIV infection with HIV-1 RNA greater than or equal to 2,000 by Roche Amplicor method, within 30 days of entry. Prior Medication: Allowed: Prior nucleoside reverse transcriptase and protease inhibitors. Cytotoxic chemotherapy more than 30 days prior to entry. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Malabsorption or severe chronic diarrhea within 30 days prior to entry, or inability to consume adequate oral intake because of chronic nausea, emesis, or abdominal or esophageal discomfort. Inadequately controlled seizure disorder. Acute and clinically significant medical event within 30 days of screening. Any clinical or laboratory abnormality greater than Grade 3 toxicity, with the exception of the listed laboratory values. Prior Medication: Excluded: Non-nucleoside reverse transcriptase inhibitor therapy. Any unapproved experimental antiretroviral therapy. Prior Treatment: Excluded: Radiation therapy within 30 days of entry, except to a local lesion. Transfusion of blood or blood products within 21 days of screening. Risk Behavior: Excluded: Active substance abuse that may interfere with compliance or protocol evaluations.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    November 2, 1999
    Last Updated
    June 23, 2005
    Sponsor
    Triangle Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00002413
    Brief Title
    A Study of MKC-442 in HIV-Positive Patients
    Official Title
    An Open Label Study of MKC-442 in at Least Triple Drug Combination in Patients Previously Treated With Nucleoside Reverse Transcriptase and Protease Inhibitors and Who Are Naive to Non-Nucleoside Reverse Transcriptase Inhibitors
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 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
    Triangle Pharmaceuticals

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to see if it is safe and effective to give MKC-442 plus at least two other anti-HIV drugs to patients who have never been treated with nonnucleoside reverse transcriptase inhibitors but who have been treated with nucleoside reverse transcriptase inhibitors and protease inhibitors. This study also determines how long a drug combination including MKC-442 is effective.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV Infections
    Keywords
    Anti-HIV Agents, Viral Load, MKC 442

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Masking
    None (Open Label)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Emivirine

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria Concurrent Medication: Allowed: Based on medical history, medical condition, prior use of antiretroviral drugs, and genotypic analysis of the predominant strain of HIV-1 isolated from plasma, administration of at least 2 available antiviral agents by prescription may be given with MKC-422. Patients must have: - HIV infection with HIV-1 RNA greater than or equal to 2,000 by Roche Amplicor method, within 30 days of entry. Prior Medication: Allowed: Prior nucleoside reverse transcriptase and protease inhibitors. Cytotoxic chemotherapy more than 30 days prior to entry. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Malabsorption or severe chronic diarrhea within 30 days prior to entry, or inability to consume adequate oral intake because of chronic nausea, emesis, or abdominal or esophageal discomfort. Inadequately controlled seizure disorder. Acute and clinically significant medical event within 30 days of screening. Any clinical or laboratory abnormality greater than Grade 3 toxicity, with the exception of the listed laboratory values. Prior Medication: Excluded: Non-nucleoside reverse transcriptase inhibitor therapy. Any unapproved experimental antiretroviral therapy. Prior Treatment: Excluded: Radiation therapy within 30 days of entry, except to a local lesion. Transfusion of blood or blood products within 21 days of screening. Risk Behavior: Excluded: Active substance abuse that may interfere with compliance or protocol evaluations.

    12. IPD Sharing Statement

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    A Study of MKC-442 in HIV-Positive Patients

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