ATV/Ritonavir Nevirapine Interaction (USPAC)

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00162149
First received: September 9, 2005
Last updated: April 7, 2011
Last verified: June 2008

September 9, 2005
April 7, 2011
October 2005
July 2006   (final data collection date for primary outcome measure)
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.
Steady state pharmacokinetics of atazanavir/ritonavir @ 300/100mg & 400/100mg each co-administered w/ nevirapine 200mg twice-daily w/ 2 nucleoside reverse transcriptase inhibitors relative to that of a second cohort of subj.
Complete list of historical versions of study NCT00162149 on ClinicalTrials.gov Archive Site
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
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 2 nucleoside rev. transcriptase inhibi
Not Provided
Not Provided
 
ATV/Ritonavir Nevirapine Interaction (USPAC)
Open-Label, Multiple-Dose, Drug Interaction Study to Assess the Effect of Nevirapine on the Pharmacokinetics of Atazanavir in HIV-Infected Individuals

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

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
HIV Infections
  • Drug: Nevirapine
    Tablets, Oral, 200 mg, Twice daily, 3 days.
  • Drug: Nevirapine + Atazanavir/Ritonavir
    Tablets + Capsules/Capsules, Oral, 200 mg + 300/100 mg, twice daily + once daily, 10 days.
    Other Name: Reyataz
  • Drug: Nevirapine + Atazanavir/Ritonavir
    Tablets + Capsules/Capsules, Oral, 200 mg + 400/100 mg, twice daily + once daily, 10 days.
    Other Name: Reyataz
  • Drug: Atazanavir + Ritonavir
    Capsules/capsules, Oral, 300/100 mg, once daily, 10 days.
    Other Name: Reyataz
  • No Intervention: A1
    Intervention: Drug: Nevirapine
  • Experimental: A2
    Intervention: Drug: Nevirapine + Atazanavir/Ritonavir
  • Experimental: A3
    Intervention: Drug: Nevirapine + Atazanavir/Ritonavir
  • No Intervention: B1
    Intervention: Drug: Atazanavir + Ritonavir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
July 2006
July 2006   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   United Kingdom
 
NCT00162149
AI424-137
Not Provided
Not Provided
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP