Effects of IGF-I in HIV Metabolic Disease (NCT01329744) | Clinical Trial Compass
TerminatedPhase 1
Effects of IGF-I in HIV Metabolic Disease
United States16 participantsStarted 2011-06
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
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What they're measuring
1
Body composition
Timeframe: 24 weeks
Trial details
NCT IDNCT01329744
SponsorUniversity of Texas Southwestern Medical Center