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

April 7, 2011 updated by: Bristol-Myers Squibb

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

22

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Hamilton, New Jersey, United States
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Drug: Atazanavir Sulphate + Ritonavir
Capsules, Oral, ATV 300 mg + RTV 100 mg, once daily, 10 days.
Other Names:
  • Reyataz
Active Comparator: B
Drug: Atazanavir Sulphate + Ritonavir + Efavirenz
Capsules/Tablets, oral, ATV 400 mg + RTV 100 mg + EFV 600 mg, once daily, 14 days.
Other Names:
  • Reyataz, Sustiva

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

September 1, 2006

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

July 26, 2006

First Submitted That Met QC Criteria

July 26, 2006

First Posted (Estimate)

July 27, 2006

Study Record Updates

Last Update Posted (Estimate)

April 8, 2011

Last Update Submitted That Met QC Criteria

April 7, 2011

Last Verified

June 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI424-283

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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