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

Effect of Atazanavir Administered With and Without Ritonavir on the Pharmacokinetics of the Cytochrome P450 2C8 Substrate Rosiglitazone in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00362726

Enrollment

Registered

2006-08-10

Start date

2006-09-30

Completion date

2006-11-30

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

Keywords

HIV

Brief summary

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.

Interventions

DRUGRosiglitazone maleate

Tablets, Oral, RGZ 4 mg, once daily, 1 day.

DRUGAtazanavir Sulphate

Capsules, Oral, ATV 400 mg, once daily, 5 days.

DRUGAtazanavir Sulphate + Rosiglitazone maleate

Capsule, Oral, ATV 400 mg + RGZ 4 mg, once daily, 1 day.

DRUGAtazanavir Sulphate + Ritonavir

Capsules, Oral, ATV 300 mg + RTV 100 mg, once daily, 14 days.

DRUGAtazanavir Sulphate + Ritonavir + Rosiglitazone maleate

Capsules/Tablets, Oral, ATV 300 mg + RTV 100 mg + RGZ 4 mg, once daily, 1 day.

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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 Rosiglitazone in healthy subjects.	—

Secondary

Measure	Time frame
To assess the safety and tolerability of Rosiglitazone and Atazanavir coadministration with and without Ritonavir.	—
To explore the relationship between Atazanavir exposure, CYP2C8 genotype and the pharmacokinetics of Rosiglitazone exposure	—

Countries

United States

Outcome results

None listed

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