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

HIV Infections Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00067782
• Other study ID #: AI424-067
• Status: Completed
• Phase: Phase 3
• First received: August 27, 2003
• Last updated: April 7, 2011
• Start date: December 2002
• Est. completion date: March 2005

Study information

• Verified date: January 2010
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: March 2005
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Atazanavir (immediate switch)
Capsules, Oral, 400mg, Once daily, 48 weeks.
• Atazanavir (Week 24 switch)
Capsules, Oral, 400mg, Once daily, 48 weeks.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm