Last updated on September 2018

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

Thanes Vanig, M.D.

Spectrum Medical Group
Phoenix, AZ United States

Michael Dube, M.D.

5P21 Rand Schrader Clinic
Los Angeles, CA United States

Jordan Lake, M.D.

University of California CARE Clinic, Los Angeles
Los Angeles, CA United States

Richard Loftus, M.D.

Palmtree Clinical Research, Inc.
Palm Springs, CA United States

Daniel Lee, M.D.

UCSD Antiviral Research Center
San Diego, CA United States

Phyllis Tien, M.D.

VAMC, Infectious Disease Section 111W
San Francisco, CA United States

Theo Hodge, Jr., M.D.

Capital Medical Associates, PC
Washington, WA United States

Gary J. Richmond, M.D.

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

Ewa Szczypinska, MD

Orange County Health Department
Orlando, FL United States

Olayemi Osiyemi, M.D.

Triple O Research Institute
West Palm Beach, FL United States

Jennifer Bartczak, M.D.

Rowan Tree Medical , P.A.
Wilton Manors, FL United States

Paul Benson, D.O.

Be Well Medical Center, P.C.
Berkley, MI United States

David Parks, M.D.

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

David Prelutsky, M.D.

Southampton Healthcare, Inc.
St. Louis, MO United States

Christopher Lucasti, D.O., FACOI

South Jersey Infectious Disease
Somers Point, NJ United States

James Lane, MD

Harold Hamm Diabetes Center at the University of Oklahoma
Oklahoma City, OK United States

Gregg Coodley, M.D., FACP

Fanno Creek Clinic, LLC
Portland, OR United States

Cynthis Brinson, M.D.

Central Texas Clinical Research
Austin, TX United States

James Sims, MD

St. Hope Foundation, Inc.
Bellaire, TX United States

Roger Bedimo, M.S., M.D.

Dallas VA Medical Center
Dallas, TX United States

Mamta Jain, M.D.

UT Southwestern Medical Center, Atten: HIV Research Unit
Dallas, TX United States

Shannon R. Schrader, M.D.

Research Access Network
Houston, TX United States

David Aboulafia, M.D.

Virginia Mason Medical Center
Seattle, WA United States

Recruitment Status: Closed

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