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

Completed · Phase 1

Conditions studied: HIV Infections, Protease Inhibitor

In brief

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

Key facts

Study ID

NCT00357188

Run by

Bristol-Myers Squibb

People needed

22

Starts

2006-07-01

Expected to finish

2006-09-01

Last updated by the study team

2011-04-08

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• Local Institution — Hamilton, New Jersey, United States

Full record on ClinicalTrials.gov

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