ClinicalTrials.Veeva

Menu

ATV/Ritonavir Nevirapine Interaction (USPAC)

Bristol-Myers Squibb (BMS) logo

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.

Trial design

46 participants in 4 patient groups

A1
No Intervention group
Treatment:
Drug: Nevirapine
A2
Experimental group
Treatment:
Drug: Nevirapine + Atazanavir/Ritonavir
Drug: Nevirapine + Atazanavir/Ritonavir
A3
Experimental group
Treatment:
Drug: Nevirapine + Atazanavir/Ritonavir
Drug: Nevirapine + Atazanavir/Ritonavir
B1
No Intervention group
Treatment:
Drug: Atazanavir + Ritonavir

Trial contacts and locations

3

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems