Status:
COMPLETED
Tesamorelin Effects on Liver Fat and Histology in HIV
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Human Immunodeficiency Virus (HIV)
Nonalcoholic Fatty Liver Disease (NAFLD)
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Liver disease is one of the leading co-morbidities of human immunodeficiency virus (HIV) infection, and nonalcoholic fatty liver disease (NAFLD) is present in approximately 30-40% of patients with HIV...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Men and women 18-70yo
- HIV-infection and treatment with a stable antiretroviral regimen for ≥ 6 months
- Hepatic steatosis as demonstrated by liver fat fraction ≥5% on 1H-MRS
- Hepatitis C antibody negative, or, if Hepatitis C antibody positive, either: a) known clinical disease, successful therapy ≥1 year prior to baseline and undetectable HCV RNA, or b) HCV resolved spontaneously and undetectable HCV RNA. Hepatitis B surface antigen negative at screen visit
- For females ≥50yo, negative mammogram within 1 year of baseline visit
- If use of Vitamin E ≥400 IU daily (in any formulation), stable dose for ≥6 months prior to study.
- Exclusion criteria:
- Heavy alcohol use defined as consumption of more than 20g daily for women or more than 30g daily for men for at least 3 consecutive months over the past 5 years
- Use of insulin or thiazoledinediones (TZDs), or HbA1c ≥7%. Individuals with mild diabetes that is well-controlled with diet and/or oral anti-diabetic agents besides TZDs will be included. Use of oral anti-diabetics must have been stable for ≥6 months prior to study entry.
- Known diabetic retinopathy.
- Known cirrhosis, or Child-Pugh score ≥7, stage 4 fibrosis on biopsy, or clinical evidence of cirrhosis or portal hypertension on imaging or exam.
- Chronic corticosteroid use except intermittent use of topical steroid creams and/or prior short-term physiologic corticosteroid use in the ≤ 6 months prior to baseline visit
- Chronic use of methotrexate, amiodarone, or tamoxifen
- Known diagnosis of Alpha-1 antitrypsin deficiency, Wilson's disease, hemochromatosis, or autoimmune hepatitis
- Use of GH or GHRH within the past 1 year
- Change in lipid lowering or anti-hypertensive regimen within 3 months of screening
- HgB \< 11.0 g/dL, CD4 \< 100 th/mm3, or HIV viral load \> 400 copies/mL
- Active malignancy
- For men, history of prostate cancer or evidence of prostate malignancy by PSA \> 5 ng/mL
- Severe chronic illness judged by the investigator to present a contraindication to participation
- History of hypopituitarism, head irradiation or any other condition known to affect the GH axis
- Use of physiologic testosterone (men) or estrogen or progesterone (women) unless stable use for a year or more prior to study entry
- Routine MRI exclusion criteria such as the presence of a pacemaker or cerebral aneurysm clip
- Previous weight loss surgery
- For women, positive pregnancy test performed in a CLIA certified laboratory using a test with a sensitivity of at least 25mIU/mL, or breastfeeding.
- Known hypersensitivity to tesamorelin or mannitol
- Unwillingness to abstain from the conception process during the study (i.e., must agree not to participate in an active attempt to become pregnant or impregnate, donate sperm, or participate in in vitro fertilization)
- Unwillingness to use one (for males) or two (for females) reliable methods of contraception while engaging in heterosexual intercourse during the study. Acceptable methods for women include hormonal contraception (estrogen/progesterone or progesterone-only formulations) if stable for a year or more prior to study entry, intrauterine device, or barrier methods (condom, or diaphragm with spermicide). Acceptable methods for males include condom use. This requirement does not apply to women who have been post-menopausal for at least 24 consecutive months or have undergone surgical sterilization, or to men who have undergone surgical sterilization or have documented azoospermia.
- Not willing or able to adhere to dose schedules and required procedures per protocol
Exclusion
Key Trial Info
Start Date :
July 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 24 2019
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT02196831
Start Date
July 1 2015
End Date
July 24 2019
Last Update
January 27 2020
Active Locations (2)
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1
National Institutes of Health
Bethesda, Maryland, United States, 20892
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114