Status:
COMPLETED
Growth Hormone Dynamics and Cardiac Steatosis in HIV
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Human Immunodeficiency Virus
Lipodystrophy
Eligibility:
All Genders
40-70 years
Brief Summary
Cardiac steatosis is increased among individuals with HIV, and may predispose to cardiac mechanical dysfunction and subsequent heart failure. The pathogenesis and treatment of cardiac steatosis is not...
Eligibility Criteria
Inclusion
- Men and women, ages 40-70 years
- Documented HIV infection on stable antiretroviral therapy for ≥ 3 months
- Abdominal obesity with waist circumference ≥ 102 cm in men, ≥ 88 cm in women
- Indication for tesamorelin per clinical judgment
Exclusion
- CD4 \< 100 cells/mm3 or HIV viral load \> 400 copies/mL
- Current active AIDS-defining illness
- History or symptoms consistent with heart failure
- Standard contraindications to MRI including severe allergy to gadolinium
- Glomerular filtration rate (eGFR) \< 45 mL/min/1.73 m2 within one month of MRI study
- Use of growth hormone-releasing hormone (GHRH) or growth hormone (GH) within the past 6 months
- HbA1c \> 7%, chronic insulin use within the past 6 months, and/or change in anti-diabetic agents within the past 3 months
- Change in statin therapy within the past 3 months
- Chronic corticosteroid use except intermittent topic steroid creams or inhalers
- Pregnancy or breastfeeding
Key Trial Info
Start Date :
January 30 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 19 2022
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT03826160
Start Date
January 30 2019
End Date
April 19 2022
Last Update
July 19 2022
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114