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

HIV Clinical Trial

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®

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01579695
• Other study ID #: EMR200147-501
• Status: Terminated
• Start date: February 2013
• Est. completion date: August 2018

Study information

• Verified date: September 2018
• Source: Theratechnologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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®.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 391
• Est. completion date: August 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• HIV

Intervention

Drug:
• Tesamorelin for injection
Daily 2 mg subcutaneous injections of Tesamorelin

Locations

Country	Name	City	State
United States	Summa Health Care System	Akron	Ohio
United States	Absolute Care Medical Center	Atlanta	Georgia
United States	Franco Felizarta, MD	Bakersfield	California
United States	St. Hope Foundation, Inc.	Bellaire	Texas
United States	Be Well Medical Center, P.C	Berkley	Michigan
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University at Buffalo, State University of NY, Erie County Medical Center	Buffalo	New York
United States	Northstar Medical Center	Chicago	Illinois
United States	Dallas VA Medical Center	Dallas	Texas
United States	University of Texas Southwestern Medical Center at Dallas	Dallas	Texas
United States	Gary J. Richmond, M.D., PA	Fort Lauderdale	Florida
United States	Pacific Coast Medical Group	Fountain Valley	California
United States	Oasis Clinic	Los Angeles	California
United States	Tower Infectious Diseases Medical Associates	Los Angeles	California
United States	University of California CARE Clinic, Los Angeles	Los Angeles	California
United States	The Kinder Medical Group-AHF	Miami	Florida
United States	Ricky K. Hsu, MD, PC	New York	New York
United States	Orange County Health Department	Orlando	Florida
United States	Orange County Health Department	Orlando	Florida
United States	Southampton Healthcare, Inc.	Saint Louis	Missouri
United States	Southhampton Clinical Research, Inc. d.b.a. Central West Clinical Research	Saint Louis	Missouri
United States	VAMC, Infectious Disease Section 111W	San Francisco	California
United States	Virginia Mason Medical Center	Seattle	Washington
United States	South Jersey Unfectious Disease	Somers Point	New Jersey
United States	Southern Illnois University School of Medicine	Springfield	Illinois
United States	The Researth Institute	Springfield	Massachusetts
United States	Virginia Mason Medical Center	Tulsa	Oklahoma
United States	Capital Medical Associates, PC	Washington	District of Columbia
United States	Dupont Circle Physician's Group	Washington	District of Columbia
United States	Reading Hospital and Medical Center	West Reading	Pennsylvania
United States	Rowan Tree Medical, P.A.	Wilton Manors	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Theratechnologies

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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