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ATV/Ritonavir Nevirapine Interaction (USPAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00162149
Recruitment Status : Completed
First Posted : September 13, 2005
Last Update Posted : April 8, 2011
Information provided by:
Bristol-Myers Squibb

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

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

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Study Type : Interventional  (Clinical Trial)
Enrollment : 46 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2005
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00162149

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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
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Layout table for additonal information Identifier: NCT00162149    
Other Study ID Numbers: AI424-137
First Posted: September 13, 2005    Key Record Dates
Last Update Posted: April 8, 2011
Last Verified: June 2008
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Atazanavir Sulfate
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers