ATV/Ritonavir Nevirapine Interaction (USPAC)

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 1

Conditions

HIV Infections

Treatments

Drug: Nevirapine

Drug: Nevirapine + Atazanavir/Ritonavir

Drug: Atazanavir + Ritonavir

Study type

Interventional

Funder types

Industry

Identifiers

NCT00162149

AI424-137

Details and patient eligibility

About

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

Sex

All

Ages

18 to 55 years old

Volunteers

No 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.