Clinical trial NCT01579695: Long-term Observational Study in HIV Subjects Exposed to EGRIFTA®
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®
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: HIV
Keywords: HIV with lipohypertrophy
Lead sponsor: Theratechnologies
Sponsor class: INDUSTRY
First posted: 2012-04-18
Enrollment: 391
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study population will be representative of the HIV-injected population affected by abdominal lipohypertrophy

Brief 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®.


Eligibility 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

Primary outcomes:
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®
timeFrame: 10 years
Secondary outcomes:
measure: 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
timeFrame: 10 years
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Franco Felizarta, MD
state: California
city: Fountain Valley
country: United States
facility: Pacific Coast Medical Group
state: California
city: Los Angeles
country: United States
facility: University of California CARE Clinic, Los Angeles
state: California
city: Los Angeles
country: United States
facility: Tower Infectious Diseases Medical Associates
state: California
city: Los Angeles
country: United States
facility: Oasis Clinic
state: California
city: San Francisco
country: United States
facility: VAMC, Infectious Disease Section 111W
state: California
city: Washington
country: United States
facility: Dupont Circle Physician's Group
state: District of Columbia
city: Washington
country: United States
facility: Capital Medical Associates, PC
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: Gary J. Richmond, M.D., PA
state: Florida
city: Miami
country: United States
facility: The Kinder Medical Group-AHF
state: Florida
city: Orlando
country: United States
facility: Orange County Health Department
state: Florida
city: Orlando
country: United States
facility: Orange County Health Department
state: Florida
city: Wilton Manors
country: United States
facility: Rowan Tree Medical, P.A.
state: Florida
city: Atlanta
country: United States
facility: Absolute Care Medical Center
state: Georgia
city: Chicago
country: United States
facility: Northstar Medical Center
state: Illinois
city: Springfield
country: United States
facility: Southern Illnois University School of Medicine
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Springfield
country: United States
facility: The Researth Institute
state: Massachusetts
city: Berkley
country: United States
facility: Be Well Medical Center, P.C
state: Michigan
city: Saint Louis
country: United States
facility: Southhampton Clinical Research, Inc. d.b.a. Central West Clinical Research
state: Missouri
city: Saint Louis
country: United States
facility: Southampton Healthcare, Inc.
state: Missouri
city: Somers Point
country: United States
facility: South Jersey Unfectious Disease
state: New Jersey
city: Buffalo
country: United States
facility: University at Buffalo, State University of NY, Erie County Medical Center
state: New York
city: New York
country: United States
facility: Ricky K. Hsu, MD, PC
state: New York
city: Akron
country: United States
facility: Summa Health Care System
state: Ohio
city: Tulsa
country: United States
facility: Virginia Mason Medical Center
state: Oklahoma
city: West Reading
country: United States
facility: Reading Hospital and Medical Center
state: Pennsylvania
city: Bellaire
country: United States
facility: St. Hope Foundation, Inc.
state: Texas
city: Dallas
country: United States
facility: Dallas VA Medical Center
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center at Dallas
state: Texas
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
Study officials:
affiliation: Theratechnologies Inc.
name: Jean-Claude Mamputu, PhD
References: