EMR200147-501 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®

  • STATUS
    Recruiting
  • sponsor
    Theratechnologies
Updated on 23 November 2020

Summary

EMR200147-501 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®

Description

The primary objective of the study is to evaluate the longterm effect of EGRIFTA®, 2 mg once daily subcutaneously (SC), on the development of malignancies in subjects with human immunodeficiency virus (HIV) infection and concomitant abdominal lipohypertrophy.

ClinicalTrials.gov Identifier: NCT01579695

Purpose: 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®.

Details
Clinical Study IdentifierTX139266
SponsorTheratechnologies
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Subject has given written informed consent
Subject is an adult man or woman ≥ 18 years old
Subject has HIV infection
Subject has physical evidence of excess abdominal fat, as determined by the examining study physician
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
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