Status:
COMPLETED
ATV/Ritonavir Nevirapine Interaction (USPAC)
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
HIV Infections
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
Open-Label, multiple-dose, drug interaction study to assess the effect of nevirapine on the pharmacokinetics of atazanavir in HIV-infected individuals.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
End Date :
July 1 2006
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00162149
Start Date
October 1 2005
End Date
July 1 2006
Last Update
April 8 2011
Active Locations (3)
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1
Local Institution
Pomona, California, United States
2
Local Institution
Seattle, Washington, United States
3
Local Institution
London, Greater London, United Kingdom