ATV/Ritonavir Nevirapine Interaction (USPAC) - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00162149

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 I

MedlinePlus related topics: AIDS

Drug Information available for: Nevirapine Ritonavir BMS 232632 Atazanavir sulfate

U.S. FDA Resources

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

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

Arms	Assigned Interventions
A1: No Intervention	Drug: Nevirapine Tablets, Oral, 200 mg, Twice daily, 3 days.
A2: Experimental	Drug: Nevirapine + Atazanavir/Ritonavir Tablets + Capsules/Capsules, Oral, 200 mg + 300/100 mg, twice daily + once daily, 10 days.
A3: Experimental	Drug: Nevirapine + Atazanavir/Ritonavir Tablets + Capsules/Capsules, Oral, 200 mg + 400/100 mg, twice daily + once daily, 10 days.
B1: No Intervention	Drug: Atazanavir + Ritonavir Capsules/capsules, Oral, 300/100 mg, once daily, 10 days.

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, Greater London
Local Institution
London, Greater London, United Kingdom

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

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

Study ID Numbers:	AI424-137
Study First Received:	September 9, 2005
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00162149 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

HIV Protease Inhibitors
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Acquired Immunodeficiency Syndrome
Atazanavir
Antiviral Agents
Immunologic Deficiency Syndromes
Protease Inhibitors

Reverse Transcriptase Inhibitors
Virus Diseases
Nevirapine
Anti-Retroviral Agents
HIV Infections
Ritonavir
Sexually Transmitted Diseases
Retroviridae Infections

Additional relevant MeSH terms:

Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
HIV Protease Inhibitors
RNA Virus Infections
Anti-HIV Agents
Immune System Diseases

Acquired Immunodeficiency Syndrome
Atazanavir
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Protease Inhibitors
Virus Diseases
Nevirapine
HIV Infections
Ritonavir
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on May 06, 2009