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Dose Finding Confirmation of Atazanavir With Ritonavir and Efavirenz (ATV/RTV + EFV) in Healthy Subjects

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT00357188
Collaborator
(none)
22
Enrollment
1
Location
2
Arms
2
Duration (Months)
10.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the exposure of Atazanavir 400 mg with Ritonavir 100 mg and with Efavirenz 600 mg compared to Atazanavir 300 mg with 100 mg without Efavirenz in Healthy Subjects

Condition or Disease Intervention/Treatment Phase
  • Drug: Atazanavir Sulphate + Ritonavir
  • Drug: Atazanavir Sulphate + Ritonavir + Efavirenz
 Phase 1

Study Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Official Title:
Open-Label, Multiple Dose Study to Determine the Relative Bioavailability of Atazanavir (ATV) 400 mg Administered With Ritonavir (RTV) and Efavirenz (EFV) Compared to Atazanavir 300 mg Administered With Ritonavir Alone in Healthy Subjects
Study Start Date :
Jul 1, 2006
Actual Primary Completion Date :
Sep 1, 2006
Actual Study Completion Date :
Sep 1, 2006

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: A

Drug: Atazanavir Sulphate + Ritonavir
Capsules, Oral, ATV 300 mg + RTV 100 mg, once daily, 10 days.
Other Names:
  • Reyataz

    		•
    Active Comparator: B

    Drug: Atazanavir Sulphate + Ritonavir + Efavirenz
    Capsules/Tablets, oral, ATV 400 mg + RTV 100 mg + EFV 600 mg, once daily, 14 days.
    Other Names:
  • Reyataz, Sustiva

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To assess the comparability of atazanavir exposure when dosed in the evening as atazanavir 400 mg with ritonavir 100 mg and with efavirenz 600 mg relative to ATV 300 mg and RTV 100 mg alone in healthy subjects []

    Secondary Outcome Measures

    1. To assess the PK of EFV when coadministered with ATV 400 mg and RTV 100 mg in the evening []

    2. To assess the PK of RTV when dosed as ATV 400 mg with RTV 100 mg and with EFV 600 mg in the evening relative to ATV 300 mg with RTV 100 mg alone []

    3. To assess the safety and tolerability of ATV and RTV alone and when coadministered with EFV in the evening in healthy subjects []

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • BMI 18-30

    • Men and women who are not of childbearing potential, ages 18-50 years, inclusive

    Exclusion Criteria:

    • History of seizures or other central nervous system disorders (including migraine headaches)

    • history of diagnosed mental illness or suicidal tendencies

    • positive screening for Hep B surface antigen

    • Hep C antibody

    • HIV-1, -2

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Local Institution Hamilton New Jersey United States

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00357188
    Other Study ID Numbers:
    • AI424-283
    First Posted:
    Jul 27, 2006
    Last Update Posted:
    Apr 8, 2011
    Last Verified:
    Jun 1, 2008
    Additional relevant MeSH terms:
    HIV Infections
    Ritonavir
    Atazanavir Sulfate
    Efavirenz

    Study Results

    No Results Posted as of Apr 8, 2011