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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00162149

Enrollment

Registered

2005-09-13

Start date

2005-10-31

Completion date

2006-07-31

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

Brief summary

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

Interventions

DRUGNevirapine + Atazanavir/Ritonavir

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

DRUGNevirapine

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

DRUGAtazanavir + Ritonavir

Capsules/capsules, Oral, 300/100 mg, once daily, 10 days.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

United Kingdom, United States

Outcome results

None listed

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