HIV Lipodystrophy
Conditions
Keywords
HIV lipodystrophy
Brief summary
This study examines the effects of recombinant insulin like growth factor - I on body composition, glucose homeostasis, and lipids, in adults with HIV infection and signs of metabolic disease.
Detailed description
The main objectives of this study are the following: 1. Determine the effect of recombinant human insulin like growth factor-I (rhIGF-I) (generic: mecasermin) on subcutaneous adiposity in patients with HIV lipodystrophy syndrome. 2. Determine the effects of rhIGF-I on glucose homeostasis and lipids in patients with HIV lipodystrophy. 3. Determine the effects of rhIGF-I on apoptosis, mitochondria, and inflammation, in adipose tissue obtained from patients with HIV lipodystrophy.
Interventions
DRUGmecasermin
a subcutaneous injection twice a day
DRUGPlacebo control
Subcutaneous injection given twice per day of placebo compound, for 24 weeks
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* HIV positive with undetectable viral load * No change in antiretrovirals for 3 months * Evidence of lipoatrophy in the limbs, and face or gluteal area * Dyslipidemia defined as: * Fasting triglycerides \> 200 OR * HDL cholesterol \< 40 mg/dL * Abnormal glucose homeostasis defined as: * Fasting hyperinsulinemia \> 20 uU/mL OR * Fasting glucose 100-125 mg/dL, inclusive
Exclusion criteria
* Two consecutive viral \>75 or \> 50 copies/mL using the tests listed above * Presence of AIDS wasting * Change in antiretroviral medication (not dose) in the prior 3 months * Coronary artery disease, cerebrovascular, or peripheral arterial disease * Diabetes mellitus * Adrenal insufficiency, hypoglycemia, thyroid disease, or other endocrine disorder that is untreated * Malignancy * Eating disorder * Pregnancy (urine pregnancy test is required of all females) * Previous liposuction or bariatric surgery * Other systemic conditions or other disorders at the discretion of the investigators * Current use of systemic glucocorticoids, or other agent affecting body weight or glucose homeostasis or other drug at the discretion of the investigators * Use of interferon within the past six months * Use of insulin, insulin secretagogue, thiazolidinedione, or metformin in the prior 3 months * Initiation or dose adjustment, within the prior 3 months, of any of the following drugs or drug classes: fibrate, cholesterol binding resin, statin, niacin, or omega 3 fatty acid (fish oil). * Use of uridine, growth hormone, IGF-I, and growth hormone releasing factor analogues
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body composition | 24 weeks | Participants will have a body scan called a dual energy x-ray absorptiometry (DEXA) scan and a single slice abdominal CT scan and mid thigh scan to measure subcutaneous and internal fat. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glucose Homeostasis | 24 weeks | Fasting glucose and insulin will be measured. A subset of patients will undergo a hyperinsulinemic clamp. |
Countries
United States
Outcome results
None listed