Study of Reyataz in HIV-infected Patients With Lipodystrophy Syndrome
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)
1 other identifier
interventional
219
9 countries
30
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2005
Typical duration for phase_4
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 25, 2005
CompletedFirst Posted
Study publicly available on registry
August 26, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedResults Posted
Study results publicly available
May 7, 2010
CompletedMay 7, 2010
April 1, 2010
2 years
August 25, 2005
December 15, 2009
April 20, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Trunk-to-limb Fat Ratio as Measured by Dual Energy X-Ray Absortiometry (DEXA) at Week 48
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.)
Baseline, Week 48
Secondary Outcomes (17)
Change From Baseline in Trunk-to-limb Fat Ratio as Measured by DEXA at Week 96
Baseline, Week 96
Mean Percent Change From Baseline in Visceral Adipose Tissue (VAT) Area by Computed Tomography (CT) Scans and in Trunk Fat by DEXA.
Baseline, Week 48, Week 96
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
Baseline, Week 48, Week 96
Mean Percent Change From Baseline in Total Body Fat by DEXA and in Total Adipose Tissue (TAT) Area by CT Scans
Baseline, Week 48, Week 96
Mean Percent Changes From Baseline in Fasting Lipids
Baseline, Week 48, Week 96
- +12 more secondary outcomes
Study Arms (2)
Switch arm
ACTIVE COMPARATORControl Arm
ACTIVE COMPARATORInterventions
Capsules, Oral, ATV 300 mg + RTV 100 mg once daily up to 96 weeks
Protease inhibitor \[PI\] combination + 2 NRTIs
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Local Institution
Fort Lauderdale, Florida, United States
Local Institution
Honolulu, Hawaii, United States
Local Institution
Huntersville, North Carolina, United States
Local Institution
Houston, Texas, United States
Local Institution
Ottawa, Ontario, Canada
Local Institution
Toronto, Ontario, Canada
Local Institution
Bondy, France
Local Institution
Lagny-sur-Marne, France
Local Institution
Lyon, France
Local Institution
Nice, France
Local Institution
Paris, France
Local Institution
Frankfurt am Main, Germany
Local Institution
München, Germany
Local Institution
Brescia, Italy
Local Institution
Milan, Italy
Local Institution
Modena, Italy
Local Institution
Roma, Italy
Local Institution
Guadalajara, Jalisco, Mexico
Local Institution
Zapopan, Jalisco, Mexico
Local Institution
Puebla City, Mexico
Local Institution
Szczecin, Poland
Local Institution
Wroclaw, Poland
Local Institution
Barcelona, Spain
Local Institution
Elche (Alicante), Spain
Local Institution
Guipuzcoa, Spain
Local Institution
Madrid, Spain
Local Institution
Málaga, Spain
Local Institution
Valencia, Spain
Local Institution
Brighton, East Sussex, United Kingdom
Local Institution
London, Greater London, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- BMS Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 25, 2005
First Posted
August 26, 2005
Study Start
July 1, 2005
Primary Completion
July 1, 2007
Study Completion
June 1, 2008
Last Updated
May 7, 2010
Results First Posted
May 7, 2010
Record last verified: 2010-04