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Effects of IGF-I in HIV Metabolic Disease

Primary Purpose

HIV Lipodystrophy

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
mecasermin
Placebo control
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Lipodystrophy focused on measuring HIV lipodystrophy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Texas Southwestern Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment

Placebo

Arm Description

Recombinant IGF-I

Outcomes

Primary Outcome Measures

Body composition
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
Fasting glucose and insulin will be measured. A subset of patients will undergo a hyperinsulinemic clamp.

Full Information

First Posted
April 4, 2011
Last Updated
March 22, 2016
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01329744
Brief Title
Effects of IGF-I in HIV Metabolic Disease
Official Title
Effects of Recombinant IGF-I in HIV Associated Metabolic Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Terminated
Study Start Date
June 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Lipodystrophy
Keywords
HIV lipodystrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Recombinant IGF-I
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
mecasermin
Other Intervention Name(s)
Increlex
Intervention Description
a subcutaneous injection twice a day
Intervention Type
Drug
Intervention Name(s)
Placebo control
Intervention Description
Subcutaneous injection given twice per day of placebo compound, for 24 weeks
Primary Outcome Measure Information:
Title
Body composition
Description
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.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Glucose Homeostasis
Description
Fasting glucose and insulin will be measured. A subset of patients will undergo a hyperinsulinemic clamp.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roy J Kim, MD, MPH
Organizational Affiliation
UT Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

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Effects of IGF-I in HIV Metabolic Disease

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