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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: Not specified

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

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Atazanavir (immediate switch)	-
2	Atazanavir (Week 24 switch)	-

Primary Outcome Measures

Name	Time	Method
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