Clinical trial NCT01329744: Effects of IGF-I in HIV Metabolic Disease
Official title: Effects of Recombinant IGF-I in HIV Associated Metabolic Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: HIV Lipodystrophy
Keywords: HIV lipodystrophy
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2011-04-06
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Body composition
timeFrame: 24 weeks
Secondary outcomes:
measure: Glucose Homeostasis
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Roy J Kim, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: