Long-term Observational Study in HIV Subjects Exposed to EGRIFTA®
- Registration Number
- NCT01579695
- Lead Sponsor
- Theratechnologies
- 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®.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 391
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.
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Exposed Group will receive Tesamorelin Tesamorelin for injection -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (29)
Gary J. Richmond, M.D., PA
🇺🇸Fort Lauderdale, Florida, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
University of Texas Southwestern Medical Center at Dallas
🇺🇸Dallas, Texas, United States
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
The Kinder Medical Group-AHF
🇺🇸Miami, 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
Be Well Medical Center, P.C
🇺🇸Berkley, Michigan, United States
The Researth Institute
🇺🇸Springfield, Massachusetts, United States
Southhampton Clinical Research, Inc. d.b.a. Central West Clinical Research
🇺🇸Saint 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
Reading Hospital and Medical Center
🇺🇸West Reading, Pennsylvania, United States
Dallas VA Medical Center
🇺🇸Dallas, Texas, United States
St. Hope Foundation, Inc.
🇺🇸Bellaire, Texas, United States
Dupont Circle Physician's Group
🇺🇸Washington, District of Columbia, United States
Capital Medical Associates, PC
🇺🇸Washington, District of Columbia, United States
Southampton Healthcare, Inc.
🇺🇸Saint Louis, Missouri, United States