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

• Status: Terminated
• Trial end date: 2018-08-01
• Target enrollment: 0
• Participant gender: All

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®.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Theratechnologies
• Treatments: Growth Hormone-Releasing Hormone; Tesamorelin

Criteria

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