Drug Interaction Study With Atazanavir Administered With and Without Ritonavir and a Cytochrome P450 Substrate Rosiglitazone

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: HIV Infections

Treatments: Drug: Atazanavir Sulphate + Rosiglitazone maleate; Drug: Atazanavir Sulphate + Ritonavir; Drug: Atazanavir Sulphate + Ritonavir + Rosiglitazone maleate; Drug: Atazanavir Sulphate; Drug: Rosiglitazone maleate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00362726

AI424-106

Details and patient eligibility

About

The purpose of this clinical research study is to assess the effect of Atazanavir 400 mg QD and Atazanavir/Ritonavir 300/100 mg QD at steady state on the single dose pharmacokinetics of RGZ in healthy subjects.

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Healthy male and female subjects between the ages 18 to 50 years old with a BMI 18 to 32 kg/m2

Trial design

14 participants in 5 patient groups

A

Active Comparator group

Treatment:

Drug: Rosiglitazone maleate

B

Active Comparator group

Treatment:

Drug: Atazanavir Sulphate

C

Active Comparator group

Treatment:

Drug: Atazanavir Sulphate + Rosiglitazone maleate

D

Active Comparator group

Treatment:

Drug: Atazanavir Sulphate + Ritonavir

E

Active Comparator group

Treatment:

Drug: Atazanavir Sulphate + Ritonavir + Rosiglitazone maleate