Long-term Observational Study in HIV Subjects Exposed to EGRIFTA®



Status:Terminated
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:9/13/2018
Start Date:February 2013
End Date:August 2018

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A Phase 4, Observational, Multicenter, 10-year Prospective Cohort Safety Study Comparing Subjects With HIV-associated Abdominal Lipohypertrophy Exposed to EGRIFTA® (Tesamorelin for Injection) to a Similar Group of Subjects Not Exposed to EGRIFTA®

The purpose of this observational, 10-year, prospective cohort study is to assess the
potential safety concerns of long-term exposure to EGRIFTA® in HIV-infected subjects with
abdominal lipohypertrophy compared with a similar group of subjects not exposed to EGRIFTA®.


Inclusion Criteria:

All of the following inclusion criteria must be fulfilled:

1. Subject has given written informed consent;

2. Subject is an adult man or woman ≥ 18 years old;

3. Subject has HIV infection;

4. Subject has physical evidence of excess abdominal fat, as determined by the examining
study physician.

5. Subject has completed standard of care assessments (mammography, cervical PAP smear,
colonoscopy and blood work for HIV-1 RNA, CD4 cell count, renal, hepatic, and
hematology, PSA test, fasting blood glucose, lipid panel ) prior to being enrolled
onto the study.

Exclusion Criteria:

Exclusion criteria 1 through 4 are based on the contraindications for EGRIFTA®.

1. Disruption of the hypothalamic-pituitary axis, including conditions such as
hypophysectomy, hypopituitarism, pituitary tumor/surgery, head irradiation, or head
trauma;

2. Active malignancy (newly diagnosed or recurrent)

3. Known hypersensitivity to tesamorelin and/or mannitol

4. Pregnancy or lactation

5. Use of EGRIFTA® within 6 months prior to baseline

6. Failure to complete any standard of care assessments listed in Section 5.2.1
We found this trial at
30
sites
Seattle, Washington 98101
(888) 862-2737
Principal Investigator: David Aboulafia, M.D.
Phone: 206-625-6926
Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Steven Grinspoon, M.D.
Phone: 617-724-9109
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5323 Harry Hines Blvd
Dallas, Texas 75235
(214) 648-3111
Principal Investigator: Mamta Jain, M.D.
Phone: 214-590-0611
Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
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Akron, Ohio 44304
Principal Investigator: Amy Hite, M.D.
Phone: 330-375-3519
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Atlanta, Georgia 30309
Principal Investigator: Joel Rosenstock, M.D.
Phone: 404-231-4431
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Bakersfield, California 93301
Principal Investigator: Franco Felizarta, M.D.
Phone: 661-324-3128
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Bellaire, Texas 77401
Principal Investigator: Stanley Lewis, M.D.
Phone: 713-844-8035
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Berkley, Michigan 48072
Principal Investigator: Paul Benson, D.O.
Phone: 248-544-9300
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Buffalo, New York 14215
Principal Investigator: Alyssa Shon, M.D.
Phone: 716-898-3055
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Chicago, Illinois 60657
Principal Investigator: Ronald Gonzales, M.D.
Phone: 773-296-2400
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4500 S. Lancaster Rd.
Dallas, Texas 75216
800-849-3597
Principal Investigator: Roger Bedimo, M.S., M.D.
Phone: 214-857-1606
Dallas VA Medical Center VA North Texas Health Care System (VANTHCS) is a progressive health...
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Fort Lauderdale, Florida 33316
Principal Investigator: Gary J. Richmond, M.D.
Phone: 954-524-2250
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Fountain Valley, California 92708
Principal Investigator: Sujata Lalla-Reddy, M.D.
Phone: 714-698-0300
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Los Angeles, California 90035
Principal Investigator: Jordan Lake, M.D.
Phone: 310-557-9640
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Los Angeles, California 90048
Principal Investigator: Cyril R. Gaultier, M.D.
Phone: 310-358-2300
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Los Angeles, California 90059
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Miami, Florida 33133
Principal Investigator: Clifford A. Kinder, M.D.
Phone: 786-497-4000
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New York, New York 10013
Principal Investigator: Ricky K. Hsu, M.D.
Phone: 212-627-7560
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Orlando, Florida 32805
Principal Investigator: Richard Solero, M.D.
Phone: 407-858-1436
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Saint Louis, Missouri 63139
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San Francisco, California 94121
Principal Investigator: Phyllis Tien, M.D.
Phone: 415-379-5518
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Somers Point, New Jersey 08244
Principal Investigator: Christopher Lucasti, D.O., FACOI
Phone: 609-927-6662
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Springfield, Illinois 62702
Principal Investigator: Janak Koirala, M.D.
Phone: 217-545-9591
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Springfield, Massachusetts 01105
Principal Investigator: Claudia Martorell, M.D., MPH
Phone: 413-747-5566
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Tulsa, Oklahoma 74127
Principal Investigator: Damon Baker, D.O.
Phone: 918-382-3591
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Washington, District of Columbia 20009
Principal Investigator: Douglas J. Ward, M.D.
Phone: 202-745-0201
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Washington, District of Columbia 20036
Principal Investigator: Theo Hodge, Jr., M.D.
Phone: 202-822-6311
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West Reading, Pennsylvania 19612
Principal Investigator: Robert Jones, D.O.
Phone: 484-628-4317
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Wilton Manors, Florida 33305
Principal Investigator: Jennifer Bartczak, M.D.
Phone: 954-533-5382
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