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Clinical Trials/NCT01329744
NCT01329744TerminatedPhase 1

Effects of Recombinant IGF-I in HIV Associated Metabolic Disease

University of Texas Southwestern Medical Center1 site in 1 country16 target enrollmentStarted: June 2011Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Terminated
Enrollment
16
Locations
1
Primary Endpoint
Body composition
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
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

Arms & Interventions

Treatment

Experimental

Recombinant IGF-I

Intervention: mecasermin (Drug)

Placebo

Placebo Comparator

Intervention: Placebo control (Drug)

Outcomes

Primary Outcomes

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 Outcomes

  • Glucose Homeostasis(24 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Roy Kim

Assistant Professor

University of Texas Southwestern Medical Center

Study Sites (1)

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