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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®.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exposed Group will receive Tesamorelin |
| ||
| Control Group will not receive Tesamorelin |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tesamorelin for injection | Drug | Daily 2 mg subcutaneous injections of Tesamorelin |
|
| 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 |
| 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 |
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Inclusion Criteria:
All of the following inclusion criteria must be fulfilled:
Exclusion Criteria:
Exclusion criteria 1 through 4 are based on the contraindications for EGRIFTA®.
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Study population will be representative of the HIV-injected population affected by abdominal lipohypertrophy
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Claude Mamputu, PhD | Theratechnologies Inc. |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Franco Felizarta, MD | Bakersfield | California | 93301 | United States | ||
| Pacific Coast Medical Group |
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| Fountain Valley |
| California |
| 92708 |
| United States |
| University of California CARE Clinic, Los Angeles | Los Angeles | California | 90035 | United States |
| Tower Infectious Diseases Medical Associates | Los Angeles | California | 90048 | United States |
| Oasis Clinic | Los Angeles | California | 90095 | United States |
| VAMC, Infectious Disease Section 111W | San Francisco | California | 94121 | United States |
| Dupont Circle Physician's Group | Washington D.C. | District of Columbia | 20009 | United States |
| Capital Medical Associates, PC | Washington D.C. | District of Columbia | 20036 | United States |
| Gary J. Richmond, M.D., PA | Fort Lauderdale | Florida | 33316 | United States |
| The Kinder Medical Group-AHF | Miami | Florida | 33133 | United States |
| Orange County Health Department | Orlando | Florida | 32805 | United States |
| Orange County Health Department | Orlando | Florida | 32809 | United States |
| Rowan Tree Medical, P.A. | Wilton Manors | Florida | 33305 | United States |
| Absolute Care Medical Center | Atlanta | Georgia | 30309 | United States |
| Northstar Medical Center | Chicago | Illinois | 60657 | United States |
| Southern Illnois University School of Medicine | Springfield | Illinois | 62702 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| The Researth Institute | Springfield | Massachusetts | 01105 | United States |
| Be Well Medical Center, P.C | Berkley | Michigan | 48072-3436 | United States |
| Southhampton Clinical Research, Inc. d.b.a. Central West Clinical Research | St Louis | Missouri | 63108 | United States |
| Southampton Healthcare, Inc. | St Louis | Missouri | 63139 | United States |
| South Jersey Unfectious Disease | Somers Point | New Jersey | 08244 | United States |
| University at Buffalo, State University of NY, Erie County Medical Center | Buffalo | New York | 14215 | United States |
| Ricky K. Hsu, MD, PC | New York | New York | 10011 | United States |
| Summa Health Care System | Akron | Ohio | 44304 | United States |
| Virginia Mason Medical Center | Tulsa | Oklahoma | 74127 | United States |
| Reading Hospital and Medical Center | West Reading | Pennsylvania | 19611 | United States |
| St. Hope Foundation, Inc. | Bellaire | Texas | 77401 | United States |
| Dallas VA Medical Center | Dallas | Texas | 75216 | United States |
| University of Texas Southwestern Medical Center at Dallas | Dallas | Texas | 75235 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98112 | United States |
| ID | Term |
|---|---|
| C479538 | tesamorelin |
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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