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

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Atazanavir Sulfate; Efavirenz; Ritonavir

Criteria

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