Effects of IGF-I in HIV Metabolic Disease | NCT01329744

Studies
Effects of IGF-I in HIV Metabolic Disease

NCT01329744

Sponsor

University of Texas Southwestern Medical Center

Status

Terminated

Last Update Posted

Mar 23, 2016Estimated

Enrollment

16Actual

Phase

Phase 1

Conditions

HIV Lipodystrophy

Interventions

mecasermin
Placebo control

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2011

Primary Completion Date

Jun 2013Actual

Completion Date

Jun 2013Actual

First Submitted Date

Apr 4, 2011

First Submission Date that Met QC Criteria

Apr 5, 2011

First Posted Date

Apr 6, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 22, 2016

Last Update Posted Date

Mar 23, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Label	Type	Description	Intervention Names
Treatment	Experimental	Recombinant IGF-I	Drug: mecasermin
Placebo	Placebo Comparator		Drug: Placebo control

Name	Type	Description	Arm Group Labels	Other Names
mecasermin	Drug	a subcutaneous injection twice a day	Treatment	Increlex

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Glucose Homeostasis	Fasting glucose and insulin will be measured. A subset of patients will undergo a hyperinsulinemic clamp.	24 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided