Clinical trial NCT00067782: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: HIV
Treatment Experienced
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2003-08-28
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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:

  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

Primary outcomes:
measure: 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 outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Local Institution
state: Arizona
city: West Hollywood
country: United States
facility: Local Institution
state: California
city: Washington
country: United States
facility: Local Institution
state: District of Columbia
city: Altamonte Springs
country: United States
facility: Local Institution
state: Florida
city: Ft. Lauderdale
country: United States
facility: Local Institution
state: Florida
city: Miami
country: United States
facility: Local Institution
state: Florida
city: Tampa
country: United States
facility: Local Institution
state: Florida
city: Boston
country: United States
facility: Local Institution
state: Massachusetts
city: Minneapolis
country: United States
facility: Local Institution
state: Minnesota
city: St. Louis
country: United States
facility: Local Institution
state: Missouri
city: East Orange
country: United States
facility: Local Institution
state: New Jersey
city: New York
country: United States
facility: Local Institution
state: New York
city: Huntersville
country: United States
facility: Local Institution
state: North Carolina
city: Cleveland
country: United States
facility: Local Institution
state: Ohio
city: Oklahoma City
country: United States
facility: Local Institution
state: Oklahoma
city: Philadelphia
country: United States
facility: Local Institution
state: Pennsylvania
city: Columbia
country: United States
facility: Local Institution
state: South Carolina
city: Fort Worth
country: United States
facility: Local Institution
state: Texas
city: Houston
country: United States
facility: Local Institution
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: