ATV/Ritonavir Nevirapine Interaction (USPAC)

Phase 1

Completed

• Conditions: HIV Infections
• Interventions: Drug: Nevirapine + Atazanavir/Ritonavir; Drug: Atazanavir + Ritonavir; Drug: Nevirapine

• Registration Number: NCT00162149
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-13
• Study Start: 2005-10
• Primary Completion: 2006-07
• Study Completion: 2006-07
• Status Verified: 2008-06
• Last Update Submitted: 2011-04-07
• Last Update Posted: 2011-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A2	Nevirapine + Atazanavir/Ritonavir	-
A3	Nevirapine + Atazanavir/Ritonavir	-
B1	Atazanavir + Ritonavir	-
A1	Nevirapine	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Local Institution; 🇬🇧 London, Greater London, United Kingdom