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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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Atazanavir (immediate switch)
Atazanavir (Week 24 switch)
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV, Treatment Experienced

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: clinical symptoms potentially related to heart block heart rate < 40 bpm 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: serum creatinine greater to or equal to 1.5 times the upper limit of normal total serum lipase greater than or equal to 1.4 times the upper limit of normal liver transaminases greater than or equal to 3 times the upper limit of normal 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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
August 27, 2003
Last Updated
April 7, 2011
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00067782
Brief Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
March 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, Treatment Experienced

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Atazanavir (immediate switch)
Other Intervention Name(s)
Reyataz
Intervention Description
Capsules, Oral, 400mg, Once daily, 48 weeks.
Intervention Type
Drug
Intervention Name(s)
Atazanavir (Week 24 switch)
Other Intervention Name(s)
Reyataz
Intervention Description
Capsules, Oral, 400mg, Once daily, 48 weeks.
Primary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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: clinical symptoms potentially related to heart block heart rate < 40 bpm 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: serum creatinine greater to or equal to 1.5 times the upper limit of normal total serum lipase greater than or equal to 1.4 times the upper limit of normal liver transaminases greater than or equal to 3 times the upper limit of normal 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Local Institution
City
West Hollywood
State/Province
California
Country
United States
Facility Name
Local Institution
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
Local Institution
City
Altamonte Springs
State/Province
Florida
Country
United States
Facility Name
Local Institution
City
Ft. Lauderdale
State/Province
Florida
Country
United States
Facility Name
Local Institution
City
Miami
State/Province
Florida
Country
United States
Facility Name
Local Institution
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Local Institution
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Local Institution
City
Minneapolis
State/Province
Minnesota
Country
United States
Facility Name
Local Institution
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
Local Institution
City
East Orange
State/Province
New Jersey
Country
United States
Facility Name
Local Institution
City
New York
State/Province
New York
Country
United States
Facility Name
Local Institution
City
Huntersville
State/Province
North Carolina
Country
United States
Facility Name
Local Institution
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
Local Institution
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Local Institution
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Local Institution
City
Columbia
State/Province
South Carolina
Country
United States
Facility Name
Local Institution
City
Fort Worth
State/Province
Texas
Country
United States
Facility Name
Local Institution
City
Houston
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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