Clinical trial NCT00135356: Study of Reyataz in HIV-infected Patients With Lipodystrophy Syndrome
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 Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV-Associated Lipodystrophy Syndrome
Keywords: HIV infections
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2005-08-26
Enrollment: 219
Sex: ALL
Minimum age (years): 18
Standard ages: 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 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.


Eligibility criteria: Inclusion Criteria:

* HIV-1 infected on HAART regimen containing 2 NRTI and boosted PI for at least 12 weeks prior to screening. Subjects may not have experienced virological failure to more than one prior PI-containing regimen. Must be able to swallow tablets
* Viral load \<400 c/mL at screening and stable for at least 6 months
* Signs of fat redistribution and lipohypertrophy (abdominal) Waist to Hip Ratio \>0.90 and Waist Circumference \>88.2 cm for men and Waist Circumference \>75.3 for women

Exclusion Criteria:

* Pregnant or breastfeeding women
* New HIV-related opportunistic infections
* Active alcohol or substance use
* Grade 4 lab toxicity
* History of taking atazanavir (ATV)
* Prohibited therapies, including non-nucleoside reverse transcriptase inhibitors (NNRTI)

Primary outcomes:
measure: Change From Baseline in Trunk-to-limb Fat Ratio as Measured by Dual Energy X-Ray Absortiometry (DEXA) at Week 48
timeFrame: Baseline, Week 48
Secondary outcomes:
measure: Change From Baseline in Trunk-to-limb Fat Ratio as Measured by DEXA at Week 96
timeFrame: Baseline, Week 96
measure: Mean Percent Change From Baseline in Visceral Adipose Tissue (VAT) Area by Computed Tomography (CT) Scans and in Trunk Fat by DEXA.
timeFrame: Baseline, Week 48, Week 96
measure: 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
timeFrame: Baseline, Week 48, Week 96
measure: Mean Percent Change From Baseline in Total Body Fat by DEXA and in Total Adipose Tissue (TAT) Area by CT Scans
timeFrame: Baseline, Week 48, Week 96
measure: Mean Percent Changes From Baseline in Fasting Lipids
timeFrame: Baseline, Week 48, Week 96
measure: Mean Changes From Baseline in Fasting Glucose at Week 48 and Week 96
timeFrame: Baseline, Week 48, Week 96
measure: Mean Changes From Baseline in Fasting Insulin at Week 48 and Week 96
timeFrame: Baseline, Week 48, Week 96
measure: Mean Changes From Baseline in Fasting Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
timeFrame: Baseline, Week 48, Week 96
measure: Mean Changes From Baseline in Body Weight at Week 48 and Week 96
timeFrame: Baseline, Week 48, Week 96
measure: Mean Changes From Baseline in Waist Circumference at Week 48 and Week 96
timeFrame: Baseline, Week 48, Week 96
measure: Mean Changes From Baseline in Body Mass Index at Week 48 and Week 96
timeFrame: Baseline, Week 48, Week 96
measure: Mean Changes From Baseline in Waist-to-Hip Ratio at Week 48 and Week 96
timeFrame: Baseline, Week 48, Week 96
measure: Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation
timeFrame: Through Week 96 of study therapy
measure: Percentage of Participants With Abnormal Liver Function Tests
timeFrame: Week 48, Week 96
measure: Percentage of Participants With Adverse Events (AEs) Leading to Discontinuation
timeFrame: Through Week 96
measure: Kaplan-Meier Cumulative Proportion of Participants Without Virologic Rebound (HIV RNA ≥400 c/mL) at Timepoints up to Week 96 in Treated Participants With HIV RNA <400 c/mL at Baseline
timeFrame: Weeks 8-12, Weeks 20-24, Weeks 32-36, Weeks 44-48, Weeks 56-60, Weeks 68-72, Weeks 80-84, Weeks 92-96
measure: Mean Change From Baseline in CD4 Count
timeFrame: Baseline, Week 48, Week 96
Other outcomes:
Locations:
city: Ft. Lauderdale
country: United States
facility: Local Institution
state: Florida
city: Honolulu
country: United States
facility: Local Institution
state: Hawaii
city: Huntersville
country: United States
facility: Local Institution
state: North Carolina
city: Houston
country: United States
facility: Local Institution
state: Texas
city: Ottawa
country: Canada
facility: Local Institution
state: Ontario
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Bondy Cedex
country: France
facility: Local Institution
city: Lagny-sur-Marne
country: France
facility: Local Institution
city: Lyon Cedex 02
country: France
facility: Local Institution
city: Lyon Cedex 03
country: France
facility: Local Institution
city: Nice Cedex
country: France
facility: Local Institution
city: Paris Cedex 12
country: France
facility: Local Institution
city: Frankfurt/ Main
country: Germany
facility: Local Institution
city: Muenchen
country: Germany
facility: Local Institution
city: Brescia
country: Italy
facility: Local Institution
city: Milano
country: Italy
facility: Local Institution
city: Modena
country: Italy
facility: Local Institution
city: Roma
country: Italy
facility: Local Institution
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Zapopan
country: Mexico
facility: Local Institution
state: Jalisco
city: Puebla
country: Mexico
facility: Local Institution
city: Szczecin
country: Poland
facility: Local Institution
city: Wroclaw
country: Poland
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Elche (Alicante)
country: Spain
facility: Local Institution
city: Guipuzcoa
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Malaga
country: Spain
facility: Local Institution
city: Valencia
country: Spain
facility: Local Institution
city: Brighton
country: United Kingdom
facility: Local Institution
state: East Sussex
city: London
country: United Kingdom
facility: Local Institution
state: Greater London
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: