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

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®

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®.

Study Overview

• Status: Terminated
• Conditions: HIV
• Intervention / Treatment: Drug: Tesamorelin for injection

• Study Type: Observational
• Enrollment (Actual): 391

Contacts and Locations

Study Locations

• United States
  • California
    • Bakersfield, California, United States, 93301
      • Franco Felizarta, MD
    • Fountain Valley, California, United States, 92708
      • Pacific Coast Medical Group
    • Los Angeles, California, United States, 90048
      • Tower Infectious Diseases Medical Associates
    • Los Angeles, California, United States, 90035
      • University of California CARE Clinic, Los Angeles
    • Los Angeles, California, United States, 90095
      • OASIS Clinic
    • San Francisco, California, United States, 94121
      • VAMC, Infectious Disease Section 111W
  • District of Columbia
    • Washington, District of Columbia, United States, 20009
      • Dupont Circle Physician's Group
    • Washington, District of Columbia, United States, 20036
      • Capital Medical Associates, PC
  • Florida
    • Fort Lauderdale, Florida, United States, 33316
      • Gary J. Richmond, M.D., PA
    • Miami, Florida, United States, 33133
      • The Kinder Medical Group-AHF
    • Orlando, Florida, United States, 32809
      • Orange County Health Department
    • Orlando, Florida, United States, 32805
      • Orange County Health Department
    • Wilton Manors, Florida, United States, 33305
      • Rowan Tree Medical, P.A.
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Absolute Care Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60657
      • Northstar Medical Center
    • Springfield, Illinois, United States, 62702
      • Southern Illnois University School of Medicine
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Springfield, Massachusetts, United States, 01105
      • The Researth Institute
  • Michigan
    • Berkley, Michigan, United States, 48072-3436
      • Be Well Medical Center, P.C
  • Missouri
    • Saint Louis, Missouri, United States, 63139
      • Southampton Healthcare, Inc.
    • Saint Louis, Missouri, United States, 63108
      • Southhampton Clinical Research, Inc. d.b.a. Central West Clinical Research
  • New Jersey
    • Somers Point, New Jersey, United States, 08244
      • South Jersey Unfectious Disease
  • New York
    • Buffalo, New York, United States, 14215
      • University at Buffalo, State University of NY, Erie County Medical Center
    • New York, New York, United States, 10011
      • Ricky K. Hsu, MD, PC
  • Ohio
    • Akron, Ohio, United States, 44304
      • Summa Health Care System
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74127
      • Virginia Mason Medical Center
  • Pennsylvania
    • West Reading, Pennsylvania, United States, 19611
      • Reading Hospital and Medical Center
  • Texas
    • Bellaire, Texas, United States, 77401
      • St. Hope Foundation, Inc.
    • Dallas, Texas, United States, 75216
      • Dallas VA Medical Center
    • Dallas, Texas, United States, 75235
      • University Of Texas Southwestern Medical Center At Dallas
  • Washington
    • Seattle, Washington, United States, 98112
      • Virginia Mason Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Study population will be representative of the HIV-injected population affected by abdominal lipohypertrophy

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Exposed Group will receive Tesamorelin	Drug: Tesamorelin for injection; Daily 2 mg subcutaneous injections of Tesamorelin
Control Group will not receive Tesamorelin

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Theratechnologies
• Investigators: Jean-Claude Mamputu, PhD, Theratechnologies Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2013
• Primary Completion (ACTUAL): May 1, 2018
• Study Completion (ACTUAL): August 1, 2018

Study Registration Dates

• First Submitted: April 12, 2012
• First Submitted That Met QC Criteria: April 16, 2012
• First Posted (ESTIMATE): April 18, 2012

Study Record Updates

• Last Update Posted (ACTUAL): September 11, 2018
• Last Update Submitted That Met QC Criteria: September 10, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: HIV with lipohypertrophy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Growth Substances; Tesamorelin
• Other Study ID Numbers: EMR200147-501