Last updated on August 2016

Diabetic Retinopathy in HIV Subjects Treated With EGRIFTA


Brief description of study

To show the non-inferiority of EGRIFTA® vs. placebo in the development or progression of Diabetic Retinopathy in HIV-infected subjects with concomitant abdominal lipohypertrophy and Type 2 diabetes mellitus (T2DM).

Detailed Study Description

To date, EGRIFTA® has not been studied for longer than 1 year in human subjects, nor has EGRIFTA® been studied in Type 2 diabetic HIV-infected subjects who are receiving oral hypoglycemic agents, GLP-1 analogues, or insulin. The present study will assess the potential of EGRIFTA® to induce or exacerbate DR in HIV-infected subjects on antiretroviral therapy who have concomitant abdominal lipohypertrophy and T2DM, and explore the long-term effects of EGRIFTA® on glycemic control and major adverse cardiovascular event (MACE) in this population.

Clinical Study Identifier: NCT01591902

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Timothy Kuberski, MD

Southwest Center for HIV/AIDS
Phoenix, AZ United States
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Thanes Vanig, M.D.

Spectrum Medical Group
Phoenix, AZ United States
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Michael Dube, M.D.

5P21 Rand Schrader Clinic
Los Angeles, CA United States
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Jordan Lake, M.D.

University of California CARE Clinic, Los Angeles
Los Angeles, CA United States
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Richard Loftus, M.D.

Palmtree Clinical Research, Inc.
Palm Springs, CA United States
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Daniel Lee, M.D.

UCSD Antiviral Research Center
San Diego, CA United States
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Phyllis Tien, M.D.

VAMC, Infectious Disease Section 111W
San Francisco, CA United States
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Theo Hodge, Jr., M.D.

Capital Medical Associates, PC
Washington, WA United States
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Gary J. Richmond, M.D.

Gary J. Richmond, M.D., PA
Fort Lauderdale, FL United States
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Ewa Szczypinska, MD

Orange County Health Department
Orlando, FL United States
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Olayemi Osiyemi, M.D.

Triple O Research Institute
West Palm Beach, FL United States
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Jennifer Bartczak, M.D.

Rowan Tree Medical , P.A.
Wilton Manors, FL United States
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Paul Benson, D.O.

Be Well Medical Center, P.C.
Berkley, MI United States
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David Parks, M.D.

Southampton Clinical Research, Inc d.b.a. Central West Clinical Research
St. Louis, MO United States
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David Prelutsky, M.D.

Southampton Healthcare, Inc.
St. Louis, MO United States
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Christopher Lucasti, D.O., FACOI

South Jersey Infectious Disease
Somers Point, NJ United States
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James Lane, MD

Harold Hamm Diabetes Center at the University of Oklahoma
Oklahoma City, OK United States
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Gregg Coodley, M.D., FACP

Fanno Creek Clinic, LLC
Portland, OR United States
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Cynthis Brinson, M.D.

Central Texas Clinical Research
Austin, TX United States
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James Sims, MD

St. Hope Foundation, Inc.
Bellaire, TX United States
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Roger Bedimo, M.S., M.D.

Dallas VA Medical Center
Dallas, TX United States
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Mamta Jain, M.D.

UT Southwestern Medical Center, Atten: HIV Research Unit
Dallas, TX United States
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Shannon R. Schrader, M.D.

Research Access Network
Houston, TX United States
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David Aboulafia, M.D.

Virginia Mason Medical Center
Seattle, WA United States
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