Effects of IGF-I in HIV Metabolic Disease

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Brief Title

Effects of IGF-I in HIV Metabolic Disease

Official Title

Effects of Recombinant IGF-I in HIV Associated Metabolic Disease

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 Phase

Phase 1

Study Type

Interventional

Primary Outcome

Body composition

Secondary Outcome

 Glucose Homeostasis

Condition

HIV Lipodystrophy

Intervention

mecasermin

Study Arms / Comparison Groups

 Treatment
Description:  Recombinant IGF-I

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

16

Start Date

June 2011

Completion Date

June 2013

Primary Completion Date

June 2013

Eligibility 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

Gender

All

Ages

18 Years - 60 Years

Accepts Healthy Volunteers

No

Contacts

Roy J Kim, MD, MPH, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT01329744

Organization ID

1K23DK080644-01A1

Responsible Party

Principal Investigator

Study Sponsor

University of Texas Southwestern Medical Center

Study Sponsor

Roy J Kim, MD, MPH, Principal Investigator, UT Southwestern Medical Center

Verification Date

March 2016