Long-term Observational Study in HIV Subjects Exposed to EGRIFTA®
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®
1 other identifier
observational
391
1 country
31
Brief Summary
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®.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2013
Longer than P75 for all trials
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2012
CompletedFirst Posted
Study publicly available on registry
April 18, 2012
CompletedStudy Start
First participant enrolled
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedSeptember 11, 2018
September 1, 2018
5.2 years
April 12, 2012
September 10, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to development of malignancies in HIV-infected subjects with abdominal lipohypertrophy exposed to EGRIFTA® vs. concurrent, comparable control group not exposed to EGRIFTA®
10 years
Secondary Outcomes (1)
Time to development or worsening of Type 2 Diabetes Mellitus, diabetic retinopathy, hypersensitivity reactions, hepatic and renal function, adverse events and major adverse cardiovascular events
10 years
Study Arms (2)
Exposed Group will receive Tesamorelin
Control Group will not receive Tesamorelin
Interventions
Daily 2 mg subcutaneous injections of Tesamorelin
Eligibility Criteria
Study population will be representative of the HIV-injected population affected by abdominal lipohypertrophy
You may qualify if:
- 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:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Franco Felizarta, MD
Bakersfield, California, 93301, United States
Pacific Coast Medical Group
Fountain Valley, California, 92708, United States
University of California CARE Clinic, Los Angeles
Los Angeles, California, 90035, United States
Tower Infectious Diseases Medical Associates
Los Angeles, California, 90048, United States
Oasis Clinic
Los Angeles, California, 90095, United States
VAMC, Infectious Disease Section 111W
San Francisco, California, 94121, United States
Dupont Circle Physician's Group
Washington D.C., District of Columbia, 20009, United States
Capital Medical Associates, PC
Washington D.C., District of Columbia, 20036, United States
Gary J. Richmond, M.D., PA
Fort Lauderdale, Florida, 33316, United States
The Kinder Medical Group-AHF
Miami, Florida, 33133, United States
Orange County Health Department
Orlando, Florida, 32805, United States
Orange County Health Department
Orlando, Florida, 32809, United States
Rowan Tree Medical, P.A.
Wilton Manors, Florida, 33305, United States
Absolute Care Medical Center
Atlanta, Georgia, 30309, United States
Northstar Medical Center
Chicago, Illinois, 60657, United States
Southern Illnois University School of Medicine
Springfield, Illinois, 62702, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
The Researth Institute
Springfield, Massachusetts, 01105, United States
Be Well Medical Center, P.C
Berkley, Michigan, 48072-3436, United States
Southhampton Clinical Research, Inc. d.b.a. Central West Clinical Research
St Louis, Missouri, 63108, United States
Southampton Healthcare, Inc.
St Louis, Missouri, 63139, United States
South Jersey Unfectious Disease
Somers Point, New Jersey, 08244, United States
University at Buffalo, State University of NY, Erie County Medical Center
Buffalo, New York, 14215, United States
Ricky K. Hsu, MD, PC
New York, New York, 10011, United States
Summa Health Care System
Akron, Ohio, 44304, United States
Virginia Mason Medical Center
Tulsa, Oklahoma, 74127, United States
Reading Hospital and Medical Center
West Reading, Pennsylvania, 19611, United States
St. Hope Foundation, Inc.
Bellaire, Texas, 77401, United States
Dallas VA Medical Center
Dallas, Texas, 75216, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75235, United States
Virginia Mason Medical Center
Seattle, Washington, 98112, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
Jean-Claude Mamputu, PhD
Theratechnologies Inc.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2012
First Posted
April 18, 2012
Study Start
February 1, 2013
Primary Completion
May 1, 2018
Study Completion
August 1, 2018
Last Updated
September 11, 2018
Record last verified: 2018-09