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

Stopped early

Conditions studied: HIV

In brief

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®.

Key facts

Study ID

NCT01579695

Run by

Theratechnologies

People needed

391

Starts

2013-02-01

Expected to finish

2018-08-01

Last updated by the study team

2018-09-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All of the following inclusion criteria must be fulfilled:
• Subject has given written informed consent;
• Subject is an adult man or woman ≥ 18 years old;
• Subject has HIV infection;
• Subject has physical evidence of excess abdominal fat, as determined by the examining study physician.
• 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.

You may not qualify if…

• Exclusion criteria 1 through 4 are based on the contraindications for EGRIFTA®.
• Disruption of the hypothalamic-pituitary axis, including conditions such as hypophysectomy, hypopituitarism, pituitary tumor/surgery, head irradiation, or head trauma;
• Active malignancy (newly diagnosed or recurrent)
• Known hypersensitivity to tesamorelin and/or mannitol
• Pregnancy or lactation
• Use of EGRIFTA® within 6 months prior to baseline
• Failure to complete any standard of care assessments listed in Section 5.2.1

Where it is running

• Franco Felizarta, MD — Bakersfield, California, United States
• Pacific Coast Medical Group — Fountain Valley, California, United States
• University of California CARE Clinic, Los Angeles — Los Angeles, California, United States
• Tower Infectious Diseases Medical Associates — Los Angeles, California, United States
• Oasis Clinic — Los Angeles, California, United States
• VAMC, Infectious Disease Section 111W — San Francisco, California, United States
• Dupont Circle Physician's Group — Washington D.C., District of Columbia, United States
• Capital Medical Associates, PC — Washington D.C., District of Columbia, United States
• Gary J. Richmond, M.D., PA — Fort Lauderdale, Florida, United States
• The Kinder Medical Group-AHF — Miami, Florida, United States
• Orange County Health Department — Orlando, Florida, United States
• Orange County Health Department — Orlando, Florida, United States
• Rowan Tree Medical, P.A. — Wilton Manors, Florida, United States
• Absolute Care Medical Center — Atlanta, Georgia, United States
• Northstar Medical Center — Chicago, Illinois, United States
• Southern Illnois University School of Medicine — Springfield, Illinois, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• The Researth Institute — Springfield, Massachusetts, United States
• Be Well Medical Center, P.C — Berkley, Michigan, United States
• Southhampton Clinical Research, Inc. d.b.a. Central West Clinical Research — St Louis, Missouri, United States
• Southampton Healthcare, Inc. — St Louis, Missouri, United States
• South Jersey Unfectious Disease — Somers Point, New Jersey, United States
• University at Buffalo, State University of NY, Erie County Medical Center — Buffalo, New York, United States
• Ricky K. Hsu, MD, PC — New York, New York, United States
• Summa Health Care System — Akron, Ohio, United States

Full record on ClinicalTrials.gov

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