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

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

ChemIDplus related topics:

Efavirenz Ritonavir Atazanavir sulfate BMS 232632

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Other, 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	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
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 October 17, 2008

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