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.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00067782
First received: August 27, 2003
Last updated: April 7, 2011
Last verified: January 2010
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


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
Study Completion Date: March 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: Atazanavir (immediate switch)
Capsules, Oral, 400mg, Once daily, 48 weeks.
Other Name: Reyataz
Active Comparator: 2 Drug: Atazanavir (Week 24 switch)
Capsules, Oral, 400mg, Once daily, 48 weeks.
Other Name: Reyataz

  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
Altamonte Springs, Florida, United States
Local Institution
Ft. Lauderdale, Florida, United States
Local Institution
Miami, Florida, United States
Local Institution
Tampa, 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
Fort Worth, Texas, United States
Local Institution
Houston, Texas, 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: NCT00067782     History of Changes
Other Study ID Numbers: AI424-067
Study First Received: August 27, 2003
Last Updated: April 7, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
HIV
Treatment Experienced

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
Atazanavir
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

ClinicalTrials.gov processed this record on April 23, 2014