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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Protease Inhibitor; HIV Infections

Treatments: Drug: Atazanavir Sulphate + Ritonavir; Drug: Atazanavir Sulphate + Ritonavir + Efavirenz

Study type: Interventional

Funder types: Industry

Identifiers

NCT00357188

AI424-283

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

22 participants in 2 patient groups

A

Active Comparator group

Treatment:

Drug: Atazanavir Sulphate + Ritonavir

B

Active Comparator group

Treatment:

Drug: Atazanavir Sulphate + Ritonavir + Efavirenz