Status:

COMPLETED

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

Lead Sponsor:

Bristol-Myers Squibb

Conditions:

HIV Infections

Protease Inhibitor

Eligibility:

All Genders

18-50 years

Phase:

PHASE1

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

Eligibility Criteria

Inclusion

  • BMI 18-30
  • Men and women who are not of childbearing potential, ages 18-50 years, inclusive

Exclusion

  • 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

Key Trial Info

Start Date :

July 1 2006

Trial Type :

INTERVENTIONAL

End Date :

September 1 2006

Estimated Enrollment :

22 Patients enrolled

Trial Details

Trial ID

NCT00357188

Start Date

July 1 2006

End Date

September 1 2006

Last Update

April 8 2011

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Local Institution

Hamilton, New Jersey, United States

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