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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
History of Changes
  Purpose

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


Condition Intervention Phase
HIV Infections
 Drug: Nevirapine
Drug: Nevirapine + Atazanavir/Ritonavir
Drug: Atazanavir + Ritonavir
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Open-Label, Multiple-Dose, Drug Interaction Study to Assess the Effect of Nevirapine on the Pharmacokinetics of Atazanavir in HIV-Infected Individuals

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

Estimated Enrollment: 46
Study Start Date: October 2005
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: A1 Drug: Nevirapine
Tablets, Oral, 200 mg, Twice daily, 3 days.
Experimental: A2 Drug: Nevirapine + Atazanavir/Ritonavir
Tablets + Capsules/Capsules, Oral, 200 mg + 300/100 mg, twice daily + once daily, 10 days.
Other Name: Reyataz
Experimental: A3 Drug: Nevirapine + Atazanavir/Ritonavir
Tablets + Capsules/Capsules, Oral, 200 mg + 400/100 mg, twice daily + once daily, 10 days.
Other Name: Reyataz
No Intervention: B1 Drug: Atazanavir + Ritonavir
Capsules/capsules, Oral, 300/100 mg, once daily, 10 days.
Other Name: Reyataz

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00162149

Locations
United States, California
Local Institution
Pomona, California, United States
United States, Washington
Local Institution
Seattle, Washington, United States
United Kingdom
Local Institution
London, Greater London, United Kingdom
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00162149     History of Changes
Other Study ID Numbers: AI424-137
Study First Received: September 9, 2005
Last Updated: April 7, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Nevirapine
Ritonavir
 Atazanavir
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
HIV Protease Inhibitors
Protease Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013