ATV/Ritonavir Nevirapine Interaction (USPAC)

HIV Infections Clinical Trial

Official title:

Open-Label, Multiple-Dose, Drug Interaction Study to Assess the Effect of Nevirapine on the Pharmacokinetics of Atazanavir in HIV-Infected Individuals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00162149
• Other study ID #: AI424-137
• Status: Completed
• Phase: Phase 1
• First received: September 9, 2005
• Last updated: April 7, 2011
• Start date: October 2005
• Est. completion date: July 2006

Study information

• Verified date: June 2008
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Nevirapine
Tablets, Oral, 200 mg, Twice daily, 3 days.
• Nevirapine + Atazanavir/Ritonavir
Tablets + Capsules/Capsules, Oral, 200 mg + 300/100 mg, twice daily + once daily, 10 days.
• Nevirapine + Atazanavir/Ritonavir
Tablets + Capsules/Capsules, Oral, 200 mg + 400/100 mg, twice daily + once daily, 10 days.
• Atazanavir + Ritonavir
Capsules/capsules, Oral, 300/100 mg, once daily, 10 days.

Locations

Country	Name	City	State
United Kingdom	Local Institution	London	Greater London
United States	Local Institution	Pomona	California
United States	Local Institution	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm