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

Study ID
EMR200147-501

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • Parkland Health & Hospital System

Contact


Principal Investigator

Official Title

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®

Brief Overview


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®.

Participant Eligibility


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