HIV
Conditions
Keywords
HIV with lipohypertrophy
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®.
Interventions
DRUGTesamorelin for injection
Daily 2 mg subcutaneous injections of Tesamorelin
Sponsors
Theratechnologies
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed