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A 14-Day Study of Racivir When Used in Combination in HIV-Infected Males

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Racivir
Sponsored by
Pharmasset
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring treatment experienced, HIV, Phase I, Combination Therapy

Eligibility Criteria

18 Years - 45 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria Subjects may be eligible to participate if they: Are males with HIV infection with a positive HIV antibody test Have an HIV-RNA copy number of ≥ 5000 copies/ml (Roche assay) Have CD4+ cell counts ≥ 50 cells/ml Are 18-45 years of age, inclusive Have a body mass index (BMI) ≥ 18 kg/m2 Are antiretroviral nucleoside reverse transcriptase inhibitor-naive Have read and understand the informed consent,and is able and willing to comply with study procedures Exclusion Criteria Subjects may not participate if they: Have clinically significant ECG abnormalities Have clinically significant abnormalities in any safety laboratory parameters Have an ALT value ≥ 3xUNL Have previously participated in this trial Have participated in another trial of an investigational drug within the last 3 months or are currently participating in another trial of an investigational drug Have a history of chronic alcohol or drug abuse within the last 6 months Have a positive urine drug screening Have a positive alcohol breath test Have any medical or psychiatric condition, which in the opinion of the investigator would jeopardize or compromise the subject's ability to participate in this trial Have a known hypersensitivity to any components of the trial medication or comparative drugs as stated in this protocol

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    June 24, 2002
    Last Updated
    July 18, 2005
    Sponsor
    Pharmasset
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00040300
    Brief Title
    A 14-Day Study of Racivir When Used in Combination in HIV-Infected Males
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2005
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2002 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    December 2002 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Pharmasset

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate Racivir. The safety, most effective dosage, and how the body reacts to Racivir will be studied.
    Detailed Description
    The study is a 14-day study with a 21-day follow-up period. During the 14-days of active study period, participants will receive Racivir once daily in combination with efavirenz and stavudine. Following the administration of the first and last dose of study medication, patients will remain in the clinic overnight. During the study there will be medical and medication histories taken, physical examinations, vital sign measurements, EKGs, and routine clinical laboratory tests.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV Infections
    Keywords
    treatment experienced, HIV, Phase I, Combination Therapy

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    18 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Racivir

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria Subjects may be eligible to participate if they: Are males with HIV infection with a positive HIV antibody test Have an HIV-RNA copy number of ≥ 5000 copies/ml (Roche assay) Have CD4+ cell counts ≥ 50 cells/ml Are 18-45 years of age, inclusive Have a body mass index (BMI) ≥ 18 kg/m2 Are antiretroviral nucleoside reverse transcriptase inhibitor-naive Have read and understand the informed consent,and is able and willing to comply with study procedures Exclusion Criteria Subjects may not participate if they: Have clinically significant ECG abnormalities Have clinically significant abnormalities in any safety laboratory parameters Have an ALT value ≥ 3xUNL Have previously participated in this trial Have participated in another trial of an investigational drug within the last 3 months or are currently participating in another trial of an investigational drug Have a history of chronic alcohol or drug abuse within the last 6 months Have a positive urine drug screening Have a positive alcohol breath test Have any medical or psychiatric condition, which in the opinion of the investigator would jeopardize or compromise the subject's ability to participate in this trial Have a known hypersensitivity to any components of the trial medication or comparative drugs as stated in this protocol

    12. IPD Sharing Statement

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    A 14-Day Study of Racivir When Used in Combination in HIV-Infected Males

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