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A Phase IIIB Study Evaluating the Effect on Serum Lipids Following a Switch to Atazanavir in HIV Infected Subjects Evidencing Virologic Suppression on Their First PI-Based Antiretroviral Therapy

This study has been completed.

Sponsored by: Bristol-Myers Squibb
Information provided by: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00067782
  Purpose

The purpose of this clinical research study is to learn if atazanavir is associated with serum LDL cholesterol in HIV-infected subjects following a substitution of atazanavir for their previously administered protease inhibitor.


Condition Intervention Phase
HIV Infections
Drug: Atazanavir (immediate switch)
Drug: Atazanavir (Week 24 switch)
Phase III

MedlinePlus related topics:   AIDS    Cholesterol   

ChemIDplus related topics:   Atazanavir sulfate    BMS 232632    Lipids   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Parallel Assignment

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Time to virologic rebound for subjects with HIV RNA < 50 c/mL at baseline; Magnitude/ durability of increases from baseline in absolute CD4 (Time-Averaged Difference) through WK12; Mean % change from baseline in fasting LDL cholesterol at WK12.

Study Start Date:   December 2002

Arms Assigned Interventions
1: Active Comparator Drug: Atazanavir (immediate switch)
Capsules, Oral, 400mg, Once daily, 48 weeks.
2: Active Comparator Drug: Atazanavir (Week 24 switch)
Capsules, Oral, 400mg, Once daily, 48 weeks.

  Eligibility
Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Key Inclusion Criteria:

  • Must be on current HIV treatment regimen at least 3 to 6 months prior to study (this must be one protease inhibitor, or ritonavir-boosted protease inhibitor, and two nucleoside reverse transcriptase inhibitors) must be subject's first PI ever received
  • Plasma HIV-1 RNA level < 50 c/mL within 3 to 6 months prior to study start
  • Fasting LDL cholesterol > 130 mg/dL

Key Exclusion Criteria:

  • WOCBP who do not use effective barrier contraception for any reason
  • Women who are pregnant or breast feeding
  • A life expectancy < 12 months
  • Presence of a newly diagnosed HIV-related OI or any medical condition requiring acute therapy at the time of enrollment
  • Cushing's Syndrome
  • Uncontrolled diabetes mellitus, history of diabetic ketoacidosis or hyperosmolar syndrome
  • Untreated hypothyroidism or hyperthyroidism
  • Nephrotic syndrome or significant proteinuria
  • Obstructive liver disease
  • Active alcohol or substance abuse
  • Proven or suspected acute hepatitis in the 30 days prior to study entry
  • Intractable diarrhea (greater than or equal to 6 loose stools/day for at least 7 consecutive days) within 30 days prior to study start
  • History of acute or chronic pancreatitis
  • Inability to swallow capsules
  • Presence of cardiomyopathy
  • Known history of prolonged QTc interval
  • Any of the following:

    1. clinical symptoms potentially related to heart block
    2. heart rate < 40 bpm
    3. any of the following EKG abnormalities:

    i) pause length > 3 seconds ii) second or third degree AV heart block iii) QTc interval > 450 msec for males iv) QTc interval > 470 msec for females

  • Fasting serum triglyceride level > 750 mg/dL
  • Any of the following lab values within 2 weeks of starting study drug:

    1. serum creatinine greater to or equal to 1.5 times the upper limit of normal
    2. total serum lipase greater than or equal to 1.4 times the upper limit of normal
    3. liver transaminases greater than or equal to 3 times the upper limit of normal
    4. total serum bilirubin greater than or equal to 1.5 times the upper limit of normal
  • Hypersensitivity to any component of the formulation of study drug
  • Use of any lipid-lowering agent within 4 weeks prior or during study
  • Use of a PI-containing ARV regimen prior to entry which is comprised of more than one PI
  • Inclusion of an NNRTI in the PI-containing regimen
  • Prisoners or subjects involuntary incarcerated for treatment of psychiatric or physical illness
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00067782

Locations
United States, Arizona
Local Institution    
      Phoenix, Arizona, United States
United States, California
Local Institution    
      West Hollywood, California, United States
United States, District of Columbia
Local Institution    
      Washington, District of Columbia, United States
United States, Florida
Local Institution    
      Ft. Lauderdale, Florida, United States
Local Institution    
      Tampa, Florida, United States
Local Institution    
      Miami, Florida, United States
Local Institution    
      Altamonte Springs, Florida, United States
United States, Massachusetts
Local Institution    
      Boston, Massachusetts, United States
United States, Minnesota
Local Institution    
      Minneapolis, Minnesota, United States
United States, Missouri
Local Institution    
      St. Louis, Missouri, United States
United States, New Jersey
Local Institution    
      East Orange, New Jersey, United States
United States, New York
Local Institution    
      New York, New York, United States
United States, North Carolina
Local Institution    
      Huntersville, North Carolina, United States
United States, Ohio
Local Institution    
      Cleveland, Ohio, United States
United States, Oklahoma
Local Institution    
      Oklahoma City, Oklahoma, United States
United States, Pennsylvania
Local Institution    
      Philadelphia, Pennsylvania, United States
United States, South Carolina
Local Institution    
      Columbia, South Carolina, United States
United States, Texas
Local Institution    
      Houston, Texas, United States
Local Institution    
      Fort Worth, Texas, 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:   AI424-067
First Received:   August 27, 2003
Last Updated:   June 27, 2008
ClinicalTrials.gov Identifier:   NCT00067782
Health Authority:   United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
HIV  
Treatment Experienced  

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
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
Protease Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections

ClinicalTrials.gov processed this record on September 05, 2008




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