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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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®.

Condition or disease	Intervention/treatment
HIV	Drug: Tesamorelin for injection

Study Design

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Study Type :	Observational
Estimated Enrollment :	3190 participants
Observational Model:	Cohort
Time Perspective:	Prospective
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 Start Date :	February 2013
Estimated Primary Completion Date :	December 2029
Estimated Study Completion Date :	March 2030

Groups and Cohorts

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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

Outcome Measures

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Primary Outcome Measures :

1. Time to development of malignancies in HIV-infected subjects with abdominal lipohypertrophy exposed to EGRIFTA® vs. concurrent, comparable control group not exposed to EGRIFTA® [ Time Frame: 10 years ]

Secondary Outcome Measures :

1. 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 [ Time Frame: 10 years ]

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

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

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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Theratechnologies Medical Information	1-844-347-4382

  Show 31 Study Locations

Sponsors and Collaborators

Theratechnologies

Investigators

OverallOfficial:	Jean-Claude Mamputu, PhD	Theratechnologies Inc.

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Theratechnologies
ClinicalTrials.gov Identifier:	NCT01579695 History of Changes
Other Study ID Numbers:	EMR200147-501
First Posted:	April 18, 2012
Last Update Posted:	August 15, 2016
Last Verified:	August 2016

Keywords provided by Theratechnologies:

HIV with lipohypertrophy

Additional relevant MeSH terms:

Growth Hormone-Releasing Hormone; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs