Effects of IGF-I in HIV Metabolic Disease

NCT01329744 | Terminated Phase 1 DMC

• 1 other identifier: 1K23DK080644-01A1
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Lipodystrophy

Keywords

HIV lipodystrophy

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• Glucose Homeostasis

  24 weeks

Study Arms (2)

Treatment

EXPERIMENTAL

Recombinant IGF-I

Drug: mecasermin

Placebo

PLACEBO COMPARATOR

Drug: Placebo control

Interventions

mecasermin DRUG

a subcutaneous injection twice a day

Also known as: Increlex

Treatment

Placebo control DRUG

Subcutaneous injection given twice per day of placebo compound, for 24 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Interventions

mecasermin

Study Officials

• Roy J Kim, MD, MPH

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 4, 2011
• First Posted: April 6, 2011
• Study Start: June 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: March 23, 2016

Record last verified: 2016-03

Locations

US (1)