Clinical Trial: Study of Reyataz in HIV-infected Patients With Lipodystrophy Syndrome
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase IV, Open-Label, Randomized, Multicenter Trial Assessing a Reyataz-Based Substitution Approach in the Management of Lipodystrophy Syndrome. Research Into Atazanavir in Lipodystrophy (The REAL S
Brief Summary: The purpose of this clinical research study is to learn if human immunodeficiency virus (HIV)-infected subjects with abdominal fat accumulation on their highly active antiretroviral treatment (HAART) regimen have better changes in fat distribution after switching to atazanavir-ritonavir than those remaining on their current protease inhibitor boosted HAART regimen.
Detailed Summary:
Sponsor: Bristol-Myers Squibb
Current Primary Outcome: Change From Baseline in Trunk-to-limb Fat Ratio as Measured by Dual Energy X-Ray Absortiometry (DEXA) at Week 48 [ Time Frame: Baseline, Week 48 ]
Original Primary Outcome:
Current Secondary Outcome:
- Change From Baseline in Trunk-to-limb Fat Ratio as Measured by DEXA at Week 96 [ Time Frame: Baseline, Week 96 ]Mean changes from baseline in trunk-to-limb fat ratio as measured by DEXA, an x-ray scan used to measure bone mineral density. Clinical improvement is associated with a decrease in values.(Baseline trunk-to-limb fat ratio values can be found in the Baseline Characteristics section.)
- Mean Percent Change From Baseline in Visceral Adipose Tissue (VAT) Area by Computed Tomography (CT) Scans and in Trunk Fat by DEXA. [ Time Frame: Baseline, Week 48, Week 96 ]The mean percent change from baseline in physical signs of lipohypertrophy, as assessed objectively by changes in visceral adipose tissue (VAT) area (cm2) by computed tomography (CT) scans and by changes in trunk fat (kg) by DEXA. Clinical improvement is associated with a decrease in values. (Baseline values can be found in the Baseline Characteristics section.)
- Mean Percent Change From Baseline in Peripheral Adipose Tissue (Limb Fat) by DEXA and by Changes in Subcutaneous Adipose Tissue (SAT) Area by CT Scans [ Time Frame: Baseline, Week 48, Week 96 ]The mean percent change from baseline in physical signs of lipoatrophy, as assessed objectively by changes in peripheral adipose tissue (ie, limb fat (kg) by DEXA and in subcutaneous adipose tissue (SAT) area by CT scans. Clinical improvement is associated with stable values, or an increase in values. (Baseline values can be found in the Baseline Characteristics section.)
- Mean Percent Change From Baseline in Total Body Fat by DEXA and in Total Adipose Tissue (TAT) Area by CT Scans [ Time Frame: Baseline, Week 48, Week 96 ]The mean percent change from baseline in total body fat by DEXA and in total adipose tissue (TAT) area by CT scans. Total body fat and TAT are both associated many factors (trunk fat + limb fat + other [weight, etc]), and thus clinical improvement cannot be predicted based solely an increase or decrease of these values. (Baseline values can be found in the Baseline Characteristics section.)
- Mean Percent Changes From Baseline in Fasting Lipids [ Time Frame: Baseline, Week 48, Week 96 ]Mean percent changes from baseline in fasting total, low-density lipoprotein (LDL), high-density lipoprotein (HDL), and non-HDL cholesterol, triglycerides, and apolipoprotein B
- Mean Changes From Baseline in Fasting Glucose at Week 48 and Week 96 [ Time Frame: Baseline, Week 48, Week 96 ]
- Mean Changes From Baseline in Fasting Insulin at Week 48 and Week 96 [ Time Frame: Baseline, Week 48, Week 96 ]
- Mean Changes From Baseline in Fasting Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) [ Time Frame: Baseline, Week 48, Week 96 ]HOMA-IR is an index used in evaluation of obese patients at risk for type 2 diabetes which requires fasting glucose and insulin concentrations. It is a mathematical model based on the theory of a negative feedback loop between the liver and β-cells that regulates both fasting glucose and insulin concentrations and can be used to estimate pancreatic β-cell function and degree of insulin resistance. HOMA-IR normal values are between 2 and 2.5. HOMA-IR ≥ 2.5 indicates insulin-resistance.
- Mean Changes From Baseline in Body Weight at Week 48 and Week 96 [ Time Frame: Baseline, Week 48, Week 96 ]
- Mean Changes From Baseline in Waist Circumference at Week 48 and Week 96 [ Time Frame: Baseline, Week 48, Week 96 ]
- Mean Changes From Baseline in Body Mass Index at Week 48 and Week 96 [ Time Frame: Baseline, Week 48, Week 96 ]
- Mean Changes From Baseline in Waist-to-Hip Ratio at Week 48 and Week 96 [ Time Frame: Baseline, Week 48, Week 96 ]Mean changes from baseline in proportion of waist to hip measurements.
- Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation [ Time Frame: Through Week 96 of study therapy ]Percentage of Participants with AEs, Serious AEs (SAEs), Deaths, and AEs leading to discontinuation. An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.
- Percentage of Participants With Abnormal Liver Function Tests [ Time Frame: Week 48, Week 96 ]Percentage of participants with Abnormal Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Total Bilirubin (TBILI) measurements. Values for liver tests
Original Secondary Outcome:
Information By: Bristol-Myers Squibb
Dates:
Date Received: August 25, 2005
Date Started: July 2005
Date Completion:
Last Updated: April 20, 2010
Last Verified: April 2010
