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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00357188
• Other study ID #: AI424-283
• Status: Completed
• Phase: Phase 1
• First received: July 26, 2006
• Last updated: April 7, 2011
• Start date: July 2006
• Est. completion date: September 2006

Study information

• Verified date: June 2008
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• HIV Infections
• Protease Inhibitor

Intervention

Drug:
• Atazanavir Sulphate + Ritonavir
Capsules, Oral, ATV 300 mg + RTV 100 mg, once daily, 10 days.
• Atazanavir Sulphate + Ritonavir + Efavirenz
Capsules/Tablets, oral, ATV 400 mg + RTV 100 mg + EFV 600 mg, once daily, 14 days.

Locations

Country	Name	City	State
United States	Local Institution	Hamilton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To assess the PK of EFV when coadministered with ATV 400 mg and RTV 100 mg in the evening
Secondary	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
Secondary	To assess the safety and tolerability of ATV and RTV alone and when coadministered with EFV in the evening in healthy subjects

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm