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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®


N/A
18 Years
N/A
Open (Enrolling)
Both
HIV

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Trial Information

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®


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.

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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Time to development of malignancies in HIV-infected subjects with abdominal lipohypertrophy exposed to EGRIFTA® vs. concurrent, comparable control group not exposed to EGRIFTA®

Outcome Time Frame:

10 years

Safety Issue:

Yes

Principal Investigator

Alexandra Mangili, MD, MPH

Investigator Role:

Study Director

Investigator Affiliation:

EMD Serono, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

EMR200147-501

NCT ID:

NCT01579695

Start Date:

February 2013

Completion Date:

January 2025

Related Keywords:

  • HIV
  • HIV with lipohypertrophy

Name

Location

Call EMD Serono Medical Information for information on recruiting sites Rockland, Massachusetts  02370
Call EMD Serono Medical Information for Recruiting Sites Rockland, Massachusetts  02370