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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00357188

Enrollment

Registered

2006-07-27

Start date

2006-07-31

Completion date

2006-09-30

Last updated

2011-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections, Protease Inhibitor

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

Interventions

DRUGAtazanavir Sulphate + Ritonavir

Capsules, Oral, ATV 300 mg + RTV 100 mg, once daily, 10 days.

DRUGAtazanavir Sulphate + Ritonavir + Efavirenz

Capsules/Tablets, oral, ATV 400 mg + RTV 100 mg + EFV 600 mg, once daily, 14 days.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026