DRUG
Tesamorelin for injection
Daily 2 mg subcutaneous injections of Tesamorelin
Long-term Observational Study in HIV Subjects Exposed to EGRIFTA®
Status
Terminated
Phase
Not applicable
Enrollment
391
Locations
31
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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®.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Apr 18, 2012
Study start
Feb 2013
Primary completion
May 2018
Study completion
Aug 2018
Results posted
Not reported
Registry updated
Sep 11, 2018
Outcomes
What the study measures.
Primary outcomes
Time to development of malignancies in HIV-infected subjects with abdominal lipohypertrophy exposed to EGRIFTA® vs. concurrent, comparable control group not exposed to EGRIFTA®
Time frame · 10 years
Secondary outcomes
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
Time frame · 10 years
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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
Study locations
31 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
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
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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More studies on Tesamorelin.
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Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.