ATV/Ritonavir Nevirapine Interaction (USPAC)

Completed · Phase 1

Conditions studied: HIV Infections

In brief

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

Key facts

Study ID

NCT00162149

Run by

Bristol-Myers Squibb

People needed

46

Starts

2005-10-01

Expected to finish

2006-07-01

Last updated by the study team

2011-04-08

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Local Institution — Pomona, California, United States
• Local Institution — Seattle, Washington, United States
• Local Institution — London, Greater London, United Kingdom

Full record on ClinicalTrials.gov

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