Effects of IGF-I in HIV Metabolic Disease

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Roy Kim, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01329744
First received: April 4, 2011
Last updated: May 23, 2013
Last verified: May 2013

April 4, 2011
May 23, 2013
June 2011
June 2013   (final data collection date for primary outcome measure)
Body composition [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01329744 on ClinicalTrials.gov Archive Site
Glucose Homeostasis [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Fasting glucose and insulin will be measured. A subset of patients will undergo a hyperinsulinemic clamp.
Same as current
Not Provided
Not Provided
 
Effects of IGF-I in HIV Metabolic Disease
Effects of Recombinant IGF-I in HIV Associated Metabolic Disease

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.

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.
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
HIV Lipodystrophy
  • Drug: mecasermin
    a subcutaneous injection twice a day
    Other Name: Increlex
  • Drug: Placebo control
    Subcutaneous injection given twice per day of placebo compound, for 24 weeks
  • Experimental: Treatment
    Recombinant IGF-I
    Intervention: Drug: mecasermin
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
16
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01329744
1K23DK080644-01A1
Yes
Roy Kim, University of Texas Southwestern Medical Center
University of Texas Southwestern Medical Center
Not Provided
Principal Investigator: Roy J Kim, MD, MPH UT Southwestern Medical Center
University of Texas Southwestern Medical Center
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP