Dose Finding Confirmation of Atazanavir With Ritonavir and Efavirenz (ATV/RTV + EFV) in Healthy Subjects
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
1 other identifier
interventional
22
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 hiv-infections
Started Jul 2006
Shorter than P25 for phase_1 hiv-infections
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 26, 2006
CompletedFirst Posted
Study publicly available on registry
July 27, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedApril 8, 2011
June 1, 2008
2 months
July 26, 2006
April 7, 2011
Conditions
Outcome Measures
Primary Outcomes (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 Outcomes (3)
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
Study Arms (2)
A
ACTIVE COMPARATORB
ACTIVE COMPARATORInterventions
Capsules, Oral, ATV 300 mg + RTV 100 mg, once daily, 10 days.
Capsules/Tablets, oral, ATV 400 mg + RTV 100 mg + EFV 600 mg, once daily, 14 days.
Eligibility Criteria
You may qualify if:
- BMI 18-30
- Men and women who are not of childbearing potential, ages 18-50 years, inclusive
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Local Institution
Hamilton, New Jersey, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 26, 2006
First Posted
July 27, 2006
Study Start
July 1, 2006
Primary Completion
September 1, 2006
Study Completion
September 1, 2006
Last Updated
April 8, 2011
Record last verified: 2008-06