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A Pilot Study of Atazanavir/Ritonavir/Efavirenz as a Nucleoside Sparing Regimen

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00135343
First received: August 25, 2005
Last updated: April 7, 2011
Last verified: July 2008
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Pilot Study of Atazanavir/Ritonavir/Efavirenz as a Nucleoside Sparing Regimen

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

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
Estimated Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: Atazanvir/ritonavir + efavirenz
Capsules (ATV and RTV) Tablets (EFV), Oral, ATV 300 mg + RTV 100 mg + EFV 600 mg, Once daily, 48 weeks.
Other Name: Reyataz & Sustiva
Experimental: B Drug: Atazanvir/ritonavir + efavirenz
Capsules (ATV and RTV) Tablets (EFV), Oral ATV 400 mg + RTV 100 mg + EFV 600 mg, Once daily, 48 weeks.
Other Name: Reyataz & Sustiva

  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
Austin, Texas, United States
Local Institution
Dallas, 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

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: NCT00135343     History of Changes
Other Study ID Numbers: AI424-121
Study First Received: August 25, 2005
Last Updated: April 7, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
HIV/AIDS

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
Ritonavir
Atazanavir
 Efavirenz
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013