Growth Hormone and/or Rosiglitazone for HIV-Associated Increased Abdominal Fat and Insulin Resistance

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Marshall Jay Glesby, MD, PhD, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00130286
First received: August 12, 2005
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

The purpose of the study is to determine if the combination of recombinant human growth hormone plus rosiglitazone (an insulin-sensitizing drug) is safe and more effective than either drug alone (or no active therapy) for the treatment of fat accumulation in people with HIV infection and insulin resistance.


Condition Intervention Phase
HIV-Associated Lipodystrophy Syndrome
Insulin Resistance
HIV Infections
Metabolic Syndrome X
Body Weight Changes
Drug: Rosiglitazone
Drug: Recombinant human growth hormone + rosiglitazone
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Recombinant Human Growth Hormone and/or Rosiglitazone in the Treatment of Human Immunodeficiency Virus-Associated Visceral Adiposity and Insulin Resistance

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Change in Insulin Sensitivity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    Change in insulin sensitivity value from baseline to week 12 by frequently sampled intravenous glucose tolerance test

    This assessment was only conducted at baseline and week 12; therefore the change reflects the difference between these two time points.



Secondary Outcome Measures:
  • Change in Visceral Adipose Tissue Volume [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    Change in visceral adipose tissue volume from baseline to week 12 measured by whole body MRI

    Data are presented only for subjects who had MRI scans done at both time points.


  • Change in Subcutaneous Adipose Tissue Volume [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    Change in subcutaneous adipose tissue volume from baseline to week 12 by whole body MRI

    Data are presented only for subjects who had MRI scans done at both time points.



Enrollment: 77
Study Start Date: March 2005
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rhGH + rosi
Recombinant human growth hormone + rosiglitazone
Drug: Rosiglitazone
4 mg tablet twice a day x 12 weeks (double-blind phase)
Drug: Recombinant human growth hormone + rosiglitazone
Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)
Experimental: rhGH placebo + rosi
Placebo for recombinant human growth hormone + rosiglitazone
Drug: Rosiglitazone
4 mg tablet twice a day x 12 weeks (double-blind phase)
Drug: Recombinant human growth hormone + rosiglitazone
Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)
Experimental: rhGH + rosi placebo
Recombinant human growth hormone + placebo for rosiglitazone
Drug: Rosiglitazone
4 mg tablet twice a day x 12 weeks (double-blind phase)
Drug: Recombinant human growth hormone + rosiglitazone
Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)
Placebo Comparator: Double placebo
Placebo for recombinant human growth hormone + placebo for rosiglitazone
Drug: Rosiglitazone
4 mg tablet twice a day x 12 weeks (double-blind phase)
Drug: Recombinant human growth hormone + rosiglitazone
Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)

Detailed Description:

A number of people with HIV infection who gain weight in the abdomen (sometimes called lipodystrophy) also have a high level of the sugar-controlling hormone called insulin. These people need to produce this extra insulin to help keep their blood sugar normal. This is called "insulin resistance."

Studies have shown that growth hormone (also called "Serostim") can decrease abdominal fat, but it can also worsen the insulin resistance. Rosiglitazone (also called "Avandia") is used to treat insulin resistance in people who have diabetes, so we want to see if taking growth hormone and rosiglitazone together will be better for treating the fat accumulation part of lipodystrophy than either drug alone or no active therapy.

The study is 24 weeks long, divided into two 12-week parts.

The first part of the study is double-blind, meaning that neither participants nor the study staff will know which drugs participants are on. Participants will be assigned randomly (like flipping a coin) to one of four groups:

  1. Growth hormone (one injection, daily) PLUS rosiglitazone (one tablet, twice daily).
  2. Growth hormone PLUS rosiglitazone placebo ("sugar pill").
  3. Growth hormone placebo (plain water injection) PLUS rosiglitazone.
  4. Growth hormone placebo PLUS rosiglitazone placebo.

Everyone in the study will need to be hospitalized overnight for special tests at the beginning of the study and at week 12.

The second part of the study is open-label, meaning that participants and the study staff will know which drugs participants are receiving. All volunteers will receive both active drugs:

  • Growth hormone (one 2 mg injection, every other day) PLUS rosiglitazone (one 4 mg tablet, twice daily).
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV-infected
  • On stable Food and Drug Administration (FDA)-approved antiretrovirals for at least 8 weeks
  • Excess abdominal fat based on waist and hip measurements done at the screening visit. [waist greater than 34.7 inches (men) or 29.6 inches (women) and waist to hip ratio greater than 0.95 (men) or 0.9 (women)]
  • Evidence of insulin resistance (based on fasting glucose and insulin levels done at screening)
  • Triglycerides less than 750 mg/dL

Exclusion Criteria:

  • Pregnancy
  • Active AIDS-defining infection or other acute illness, within 30 days of entry.
  • Active cancer (except for localized Kaposi's sarcoma) or active brain tumor
  • Any diagnosis of pancreatitis, carpal tunnel syndrome, diabetes, angina, coronary artery disease, or disorder associated with fluid retention (examples: cirrhosis, congestive heart failure)
  • Untreated or uncontrolled high blood pressure, within 30 days of entry.
  • Within 12 weeks of study entry, use of the following:

    • Obesity (fat-reducing) drugs.
    • Anti-diabetic or insulin-sensitizing drugs (examples: rosiglitazone, pioglitazone, or metformin).
    • Systemic glucocorticoids (example: prednisone).
    • Growth hormone or any medication for AIDS-associated wasting.
    • Systemic chemotherapy, interferon, or radiation therapy.
    • Androgenic agents [examples: nandrolone, oxandrolone (Oxandrin) (testosterone replacement therapy is permitted if started more than 30 days before entry)]
    • Appetite stimulants (Marinol, Megace, Periactin).
  • Use of cholesterol lowering drugs, unless started more than 12 weeks before entry
  • Inability to have a magnetic resonance imaging (MRI) scan performed (examples: cardiac pacemaker, intracranial aneurysm clips)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00130286

Locations
United States, New York
Cornell HIV Clinical Trials Unit, Weill Medical College of Cornell University
New York, New York, United States, 10021
St. Luke's-Roosevelt Hospital Center
New York, New York, United States, 10025
Columbia University College of Physicians and Surgeons
New York, New York, United States, 10032
AIDS Community Research Initiative of America (ACRIA)
New York, New York, United States, 10018
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Marshall J Glesby, MD, PhD Weill Medical College of Cornell University
  More Information

Publications:
Responsible Party: Marshall Jay Glesby, MD, PhD, Professor of Medicine and Public Health, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00130286     History of Changes
Other Study ID Numbers: 65515, R01DK065515
Study First Received: August 12, 2005
Results First Received: December 16, 2013
Last Updated: February 10, 2014
Health Authority: United States: Federal Government

Keywords provided by Weill Medical College of Cornell University:
Lipodystrophy
HIV
Growth hormone
Rosiglitazone
Visceral fat
Metabolic syndrome
Treatment Experienced
Visceral fat accumulation
fat accumulation
HIV-Associated Metabolic Syndrome

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Body Weight
Body Weight Changes
Insulin Resistance
Lipodystrophy
Metabolic Syndrome X
HIV-Associated Lipodystrophy Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Signs and Symptoms
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders
Hormones
Rosiglitazone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Hypoglycemic Agents

ClinicalTrials.gov processed this record on July 10, 2014