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

Study Overview
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Brief Summary
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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®.

Official Title
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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®

Conditions
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HIV

Intervention / Treatment
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* Drug: Tesamorelin for injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All of the following inclusion criteria must be fulfilled: 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. Exclusion Criteria: Exclusion criteria 1 through 4 are based on the contraindications for EGRIFTA®. Disruption of the hypothalamic-pituitary axis, including conditions such as hypophysectomy, hypopituitarism, pituitary tumor/surgery, head irradiation, or head trauma; Active malignancy (newly diagnosed or recurrent) Known hypersensitivity to tesamorelin and/or mannitol Pregnancy or lactation Use of EGRIFTA® within 6 months prior to baseline Failure to complete any standard of care assessments listed in Section 5.2.1

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Exposed Group will receive Tesamorelin<br> | Drug: Tesamorelin for injection<br>* Daily 2 mg subcutaneous injections of Tesamorelin<br>|
| Control Group will not receive Tesamorelin<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV with lipohypertrophy