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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

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

Intervention: Atazanavir (immediate switch) (Drug); Atazanavir (Week 24 switch) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

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.

Clinical Details

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

Primary outcome: 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.

Eligibility

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Local Institution, Phoenix, Arizona, United States

Local Institution, West Hollywood, California, United States

Local Institution, Washington, District of Columbia, United States

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

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

Additional Information

BMS Clinical Trials Disclosure

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm

Starting date: December 2002
Last updated: April 7, 2011

Page last updated: August 23, 2015

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