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

NCT ID: NCT00067782

Last Updated: 2011-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-12-31
• Study Completion Date: 2005-03-31

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.

Conditions

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: ACTIVE_COMPARATOR

Atazanavir (immediate switch)

Intervention Type: DRUG

Capsules, Oral, 400mg, Once daily, 48 weeks.

2

Group Type: ACTIVE_COMPARATOR

Atazanavir (Week 24 switch)

Intervention Type: DRUG

Capsules, Oral, 400mg, Once daily, 48 weeks.

Interventions

Atazanavir (immediate switch)

Capsules, Oral, 400mg, Once daily, 48 weeks.

Intervention Type: DRUG

Atazanavir (Week 24 switch)

Capsules, Oral, 400mg, Once daily, 48 weeks.

Intervention Type: DRUG

Other Intervention Names

Reyataz; Reyataz

Eligibility Criteria

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

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Local Institution

Phoenix, Arizona, United States

Local Institution

West Hollywood, California, United States

Local Institution

Washington D.C., District of Columbia, United States

Local Institution

Altamonte Springs, Florida, United States

Local Institution

Fort Lauderdale, Florida, United States

Local Institution

Miami, Florida, United States

Local Institution

Tampa, Florida, United States

Local Institution

Boston, Massachusetts, United States

Local Institution

Minneapolis, Minnesota, United States

Local Institution

St Louis, Missouri, United States

Local Institution

East Orange, New Jersey, United States

Local Institution

New York, New York, United States

Local Institution

Huntersville, North Carolina, United States

Local Institution

Cleveland, Ohio, United States

Local Institution

Oklahoma City, Oklahoma, United States

Local Institution

Philadelphia, Pennsylvania, United States

Local Institution

Columbia, South Carolina, United States

Local Institution

Fort Worth, Texas, United States

Local Institution

Houston, Texas, United States

Countries

United States

Other Identifiers

AI424-067

Identifier Type: -

Identifier Source: org_study_id