Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Massachusetts General Hospital
With
National Institute of Allergy and Infectious Diseases (NIAID)
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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
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
