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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 96

Mean 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

Page last updated: August 23, 2015

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