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ATV/Ritonavir Nevirapine Interaction (USPAC) | Clinical Trials | Clareo Health

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ATV/Ritonavir Nevirapine Interaction (USPAC)

Open-Label, Multiple-Dose, Drug Interaction Study to Assess the Effect of Nevirapine on the Pharmacokinetics of Atazanavir in HIV-Infected Individuals

NCT00162149•Bristol-Myers Squibb

View on ClinicalTrials.gov

Summary

Open-Label, multiple-dose, drug interaction study to assess the effect of nevirapine on the pharmacokinetics of atazanavir in HIV-infected individuals.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•signed informed consent form
•For Cohort 1, HIV-infected subjects receiving nevirapine 200 mg twice-daily and 2 to 3 NRTIs for at least 6 weeks
•For Cohort 2, HIV-infected subjects receiving atazanavir 300 mg and ritonavir 100 mg once-daily and 2 to 3 NRTIs for at least 6 weeks
•Have had 2 measurements of plasma HIV RNA of \<400 copies/mL. The first test being 6 to 16 weeks prior and the second being within 3 weeks prior to Day 1
•Have CD4 cell count \>=200 cells/mm3
•Body Mass Index of 18 to 35 kg/m2.
•Men and women, ages 18 to 55.

Exclusion Criteria

•Women who are pregnant or breastfeeding
•Presence of a newly diagnosed HIV-related opportunistic infection or CD4 cell count \<200 cell/mm3 within the previous 6 months.
•Any significant acute or chronic medical illness, unless stable or controlled by a non-prohibited medication.
•History of virologic failure on an antiretroviral regimen.

Locations (3)

Local Institution

Pomona, California, United States

Local Institution

Seattle, Washington, United States

Local Institution

London, Greater London, United Kingdom

Key Dates

Start Date

October 1, 2005

Primary Completion Date

July 1, 2006

Completion Date

July 1, 2006

Last Updated

April 8, 2011

Enrollment

Estimated participants

Conditions

HIV Infections

Interventions

Nevirapine

DRUG

Nevirapine + Atazanavir/Ritonavir

DRUG

Nevirapine + Atazanavir/Ritonavir

DRUG

Atazanavir + Ritonavir

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 8, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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ATV/Ritonavir Nevirapine Interaction (USPAC)

Inclusion Criteria

Exclusion Criteria

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