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

History of Changes

Tracking Information

First Received Date ^ICMJE

April 4, 2011

Last Updated Date

May 23, 2013

Start Date ^ICMJE

June 2011

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01329744 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Effects of IGF-I in HIV Metabolic Disease

Official Title ^ICMJE

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:

Determine the effect of recombinant human insulin like growth factor-I (rhIGF-I) (generic: mecasermin) on subcutaneous adiposity in patients with HIV lipodystrophy syndrome.
Determine the effects of rhIGF-I on glucose homeostasis and lipids in patients with HIV lipodystrophy.
Determine the effects of rhIGF-I on apoptosis, mitochondria, and inflammation, in adipose tissue obtained from patients with HIV lipodystrophy.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

HIV Lipodystrophy

Intervention ^ICMJE

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

Study Arm (s)

Experimental: Treatment
Recombinant IGF-I

Intervention: Drug: mecasermin
Placebo Comparator: Placebo
Intervention: Drug: Placebo control

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Estimated Completion Date

June 2013

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01329744

Other Study ID Numbers ^ICMJE

1K23DK080644-01A1

Has Data Monitoring Committee

Yes

Responsible Party

Roy Kim, University of Texas Southwestern Medical Center

Study Sponsor ^ICMJE

University of Texas Southwestern Medical Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Roy J Kim, MD, MPH

UT Southwestern Medical Center

Information Provided By

University of Texas Southwestern Medical Center

Verification Date

May 2013

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

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