Dose Finding Confirmation of Atazanavir With Ritonavir and Efavirenz (ATV/RTV + EFV) in Healthy Subjects
Phase 1
Completed
- Conditions
- HIV InfectionsProtease Inhibitor
- Interventions
- Registration Number
- NCT00357188
- Lead Sponsor
- Bristol-Myers Squibb
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A Atazanavir Sulphate + Ritonavir - B Atazanavir Sulphate + Ritonavir + Efavirenz -
- Primary Outcome Measures
Name Time Method 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
Name Time Method To assess the PK of EFV when coadministered with ATV 400 mg and RTV 100 mg in the evening 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 To assess the safety and tolerability of ATV and RTV alone and when coadministered with EFV in the evening in healthy subjects
Trial Locations
- Locations (1)
Local Institution
🇺🇸Hamilton, New Jersey, United States