Effects of IGF-I in HIV Metabolic Disease

HIV Lipodystrophy Clinical Trial

Official title:

Effects of Recombinant IGF-I in HIV Associated Metabolic Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01329744
• Other study ID #: 1K23DK080644-01A1
• Status: Terminated
• Phase: Phase 1
• First received: April 4, 2011
• Last updated: March 22, 2016
• Start date: June 2011
• Est. completion date: June 2013

Study information

• Verified date: March 2016
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• HIV Lipodystrophy
• Lipodystrophy
• Metabolic Diseases

Intervention

Drug:
• mecasermin
a subcutaneous injection twice a day
• Placebo control
Subcutaneous injection given twice per day of placebo compound, for 24 weeks

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Glucose Homeostasis	Fasting glucose and insulin will be measured. A subset of patients will undergo a hyperinsulinemic clamp.	24 weeks	No