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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Efavirenz
Ritonavir
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Protease Inhibitors
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014