ATV/Ritonavir Nevirapine Interaction (USPAC)

Bristol-Myers Squibb46 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Masking

NONE

Enrollment

Conditions

HIV Infections

Interventions

NevirapineDRUG

Tablets, Oral, 200 mg, Twice daily, 3 days.

Nevirapine + Atazanavir/RitonavirDRUG

Tablets + Capsules/Capsules, Oral, 200 mg + 300/100 mg, twice daily + once daily, 10 days.

Nevirapine + Atazanavir/RitonavirDRUG

Tablets + Capsules/Capsules, Oral, 200 mg + 400/100 mg, twice daily + once daily, 10 days.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Steady state pharmacokinetics of atazanavir/ritonavir 300/100mg & 400/100mg each co-administered w/ nevirapine 200mg twice-daily w/ 2 to 3 nucleoside reverse transcriptase inhibitors relative to that of a second cohort of subj.

Secondary Outcomes

Steady state PK of 2 atazanavir/ritonavir&nevirapine regimens relative to historic data of atazanavir 400mg in HIV-inf subj;Safety & tolerability of co-admin of atazanavir,ritonavir,&nevirapine in the presence of 2to3 nucleoside rev. transcriptase inhibi

Data from ClinicalTrials.gov

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