Effects of IGF-I in HIV Metabolic Disease

Stopped early · Phase 1 · Has a placebo group

Conditions studied: HIV Lipodystrophy

In brief

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.

Key facts

Study ID

NCT01329744

Run by

University of Texas Southwestern Medical Center

People needed

16

Starts

2011-06-01

Expected to finish

2013-06-01

Last updated by the study team

2016-03-23

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Texas Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.