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

April 7, 2011 updated by: Bristol-Myers Squibb
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States
        • Local Institution
    • California
      • West Hollywood, California, United States
        • Local Institution
    • District of Columbia
      • Washington, District of Columbia, United States
        • Local Institution
    • Florida
      • Altamonte Springs, Florida, United States
        • Local Institution
      • Ft. Lauderdale, Florida, United States
        • Local Institution
      • Miami, Florida, United States
        • Local Institution
      • Tampa, Florida, United States
        • Local Institution
    • Massachusetts
      • Boston, Massachusetts, United States
        • Local Institution
    • Minnesota
      • Minneapolis, Minnesota, United States
        • Local Institution
    • Missouri
      • St. Louis, Missouri, United States
        • Local Institution
    • New Jersey
      • East Orange, New Jersey, United States
        • Local Institution
    • New York
      • New York, New York, United States
        • Local Institution
    • North Carolina
      • Huntersville, North Carolina, United States
        • Local Institution
    • Ohio
      • Cleveland, Ohio, United States
        • Local Institution
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Local Institution
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Local Institution
    • South Carolina
      • Columbia, South Carolina, United States
        • Local Institution
    • Texas
      • Fort Worth, Texas, United States
        • Local Institution
      • Houston, Texas, United States
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 2
Drug: Atazanavir (Week 24 switch)
Capsules, Oral, 400mg, Once daily, 48 weeks.
Other Names:
  • Reyataz
Active Comparator: 1
Drug: Atazanavir (immediate switch)
Capsules, Oral, 400mg, Once daily, 48 weeks.
Other Names:
  • Reyataz

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2002

Primary Completion (Actual)

March 1, 2005

Study Completion (Actual)

March 1, 2005

Study Registration Dates

First Submitted

August 27, 2003

First Submitted That Met QC Criteria

August 27, 2003

First Posted (Estimate)

August 28, 2003

Study Record Updates

Last Update Posted (Estimate)

April 14, 2011

Last Update Submitted That Met QC Criteria

April 7, 2011

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI424-067

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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