Effects of IGF-I in HIV Metabolic Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01329744
Recruitment Status : Terminated
First Posted : April 6, 2011
Last Update Posted : March 23, 2016
Information provided by (Responsible Party):
Roy Kim, University of Texas Southwestern Medical Center

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.

Condition or disease Intervention/treatment Phase
HIV Lipodystrophy Drug: mecasermin Drug: Placebo control Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Recombinant IGF-I in HIV Associated Metabolic Disease
Study Start Date : June 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Mecasermin

Arm Intervention/treatment
Experimental: Treatment
Recombinant IGF-I
Drug: mecasermin
a subcutaneous injection twice a day
Other Name: Increlex

Placebo Comparator: Placebo Drug: Placebo control
Subcutaneous injection given twice per day of placebo compound, for 24 weeks

Primary Outcome Measures :
  1. Body composition [ Time Frame: 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 Outcome Measures :
  1. Glucose Homeostasis [ Time Frame: 24 weeks ]
    Fasting glucose and insulin will be measured. A subset of patients will undergo a hyperinsulinemic clamp.

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01329744

United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Principal Investigator: Roy J Kim, MD, MPH UT Southwestern Medical Center

Responsible Party: Roy Kim, Assistant Professor, University of Texas Southwestern Medical Center Identifier: NCT01329744     History of Changes
Other Study ID Numbers: 1K23DK080644-01A1 ( U.S. NIH Grant/Contract )
First Posted: April 6, 2011    Key Record Dates
Last Update Posted: March 23, 2016
Last Verified: March 2016

Keywords provided by Roy Kim, University of Texas Southwestern Medical Center:
HIV lipodystrophy

Additional relevant MeSH terms:
Metabolic Diseases
Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders
Growth Substances
Physiological Effects of Drugs