A Pilot Study of Atazanavir/Ritonavir/Efavirenz as a Nucleoside Sparing Regimen - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00135343

Purpose

The purpose of this study is to evaluate the safety and efficacy of a novel nucleoside sparing regimen containing atazanavir, ritonavir and efavirenz, using two different doses of atazanavir.

Condition	Intervention	Phase
HIV Infections	Drug: Atazanvir/ritonavir + efavirenz	Phase III

MedlinePlus related topics: AIDS

Drug Information available for: Efavirenz Ritonavir Atazanavir sulfate BMS 232632

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Pilot Study of Atazanavir/Ritonavir/Efavirenz as a Nucleoside Sparing Regimen

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Mean percent change from baseline in fasting plasma triglycerides at Week 8

Secondary Outcome Measures:

Incidence of grade 2-4 elevation of fasting plasma triglycerides at Week (Wk) 8, 24 and 48
The mean percent change from baseline in fasting plasma triglycerides at Wk 24 and 48

Estimated Enrollment:	60
Study Start Date:	April 2004

Arms	Assigned Interventions
A: Experimental	Drug: Atazanvir/ritonavir + efavirenz Capsules (ATV and RTV) Tablets (EFV), Oral, ATV 300 mg + RTV 100 mg + EFV 600 mg, Once daily, 48 weeks.
B: Experimental	Drug: Atazanvir/ritonavir + efavirenz Capsules (ATV and RTV) Tablets (EFV), Oral ATV 400 mg + RTV 100 mg + EFV 600 mg, Once daily, 48 weeks.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Provide written informed consent
HIV positive with plasma HIV RNA viral load of ≥ 1000 copies/mL and CD4 cell count of ≥ 50 cells/mm3
Antiretroviral (ARV) naive prior to enrollment
Normal plasma triglycerides ≤ 200 mg/dL
Women of child-bearing age must use effective barrier contraception

Exclusion Criteria:

Pregnancy or breast feeding
Evidence of resistance to antiretroviral drugs
History of elevated blood cholesterol or triglycerides
History of diabetes
Hypersensitivity to any component of the study drugs
Any cholesterol or triglyceride lowering medications in the past six months
Use of growth hormone, megestrol acetate, or anabolic steroids in the past six months
Imprisonment or involuntary incarceration for medical treatment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00135343

Locations

United States, California
Local Institution
San Francisco, California, United States
United States, District of Columbia
Local Institution
Washington, District of Columbia, United States
United States, Florida
Local Institution
Atlantis, Florida, United States
Local Institution
Orlando, Florida, United States
Local Institution
South Miami, Florida, United States
Local Institution
Tampa, Florida, United States
United States, Louisiana
Local Institution
New Orleans, Louisiana, United States
United States, Massachusetts
Local Institution
Boston, Massachusetts, United States
United States, Michigan
Local Institution
Berkley, Michigan, United States
United States, Missouri
Local Institution
St. Louis, Missouri, United States
United States, North Carolina
Local Institution
Huntersville, North Carolina, United States
United States, South Carolina
Local Institution
Clumbia, South Carolina, United States
United States, Texas
Local Institution
dallas, Texas, United States
Local Institution
Dallas, Texas, United States
Local Institution
Austin, Texas, United States
United States, Virginia
Local Institution
Hampton, Virginia, United States

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More 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

Study ID Numbers:	AI424-121
Study First Received:	August 25, 2005
Last Updated:	July 7, 2008
ClinicalTrials.gov Identifier:	NCT00135343
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

HIV/AIDS

Study placed in the following topic categories:

Virus Diseases
Efavirenz
Sexually Transmitted Diseases, Viral
Ritonavir
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Atazanavir
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
HIV Protease Inhibitors
Slow Virus Diseases
Anti-HIV Agents
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Infection

Antiviral Agents
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Protease Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009