Study of Reyataz in HIV-infected Patients With Lipodystrophy Syndrome
Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV-Associated Lipodystrophy Syndrome
Intervention: Atazanavir (ATV) + ritonavir (RTV), continuation of backbone 2 nucleoside reverse transcriptase inhibitor (NRTIs) (Drug); continuation of current HAART (boosted protease inhibitor [PI] combination + 2 NRTIs) (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Bristol-Myers Squibb Official(s) and/or principal investigator(s): Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change From Baseline in Trunk-to-limb Fat Ratio as Measured by Dual Energy X-Ray Absortiometry (DEXA) at Week 48
Secondary outcome: Change From Baseline in Trunk-to-limb Fat Ratio as Measured by DEXA at Week 96Mean Percent Change From Baseline in Visceral Adipose Tissue (VAT) Area by Computed Tomography (CT) Scans and in Trunk Fat by DEXA. 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 Mean Percent Change From Baseline in Total Body Fat by DEXA and in Total Adipose Tissue (TAT) Area by CT Scans Mean Percent Changes From Baseline in Fasting Lipids Mean Changes From Baseline in Fasting Glucose at Week 48 and Week 96 Mean Changes From Baseline in Fasting Insulin at Week 48 and Week 96 Mean Changes From Baseline in Fasting Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) Mean Changes From Baseline in Body Weight at Week 48 and Week 96 Mean Changes From Baseline in Waist Circumference at Week 48 and Week 96 Mean Changes From Baseline in Body Mass Index at Week 48 and Week 96 Mean Changes From Baseline in Waist-to-Hip Ratio at Week 48 and Week 96 Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation Percentage of Participants With Abnormal Liver Function Tests Percentage of Participants With Adverse Events (AEs) Leading to Discontinuation 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 Mean Change From Baseline in CD4 Count
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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)
Locations and Contacts
Local Institution, Bondy Cedex, France
Local Institution, Lagny-sur-Marne, France
Local Institution, Lyon Cedex 02, France
Local Institution, Lyon Cedex 03, France
Local Institution, Nice Cedex, France
Local Institution, Paris Cedex 12, France
Local Institution, Frankfurt/ Main, Germany
Local Institution, Muenchen, Germany
Local Institution, Brescia, Italy
Local Institution, Milano, Italy
Local Institution, Modena, Italy
Local Institution, Roma, Italy
Local Institution, Puebla, 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, Malaga, Spain
Local Institution, Valencia, Spain
Local Institution, Brighton, East Sussex, United Kingdom
Local Institution, Ft. Lauderdale, Florida, United States
Local Institution, London, Greater London, United Kingdom
Local Institution, Honolulu, Hawaii, United States
Local Institution, Guadalajara, Jalisco, Mexico
Local Institution, Zapopan, Jalisco, Mexico
Local Institution, Huntersville, North Carolina, United States
Local Institution, Ottawa, Ontario, Canada
Local Institution, Toronto, Ontario, Canada
Local Institution, Houston, Texas, United States
Additional Information
BMS Clinical Trials Disclosure For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm
Starting date: July 2005
Last updated: April 20, 2010
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