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
  Purpose

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 Intervention Phase
HIV Lipodystrophy
Drug: mecasermin
Drug: Placebo control
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Recombinant IGF-I in HIV Associated Metabolic Disease

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 16
Study Start Date: June 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01329744

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

No publications provided

Responsible Party: Roy Kim, Assistant Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01329744     History of Changes
Other Study ID Numbers: 1K23DK080644-01A1
Study First Received: April 4, 2011
Last Updated: May 23, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Lipodystrophy
Metabolic Diseases
Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on August 01, 2014