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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

August 12, 2005
February 10, 2014
March 2005
August 2010   (final data collection date for primary outcome measure)
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.

Change in insulin sensitivity
Complete list of historical versions of study NCT00130286 on ClinicalTrials.gov Archive Site
  • 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.

  • Change in body fat (total and regional; visceral and subcutaneous)
  • Other body composition and metabolic endpoints
Not Provided
Not Provided
 
Growth Hormone and/or Rosiglitazone for HIV-Associated Increased Abdominal Fat and Insulin Resistance
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

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.

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).
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • HIV-Associated Lipodystrophy Syndrome
  • Insulin Resistance
  • HIV Infections
  • Metabolic Syndrome X
  • Body Weight Changes
  • 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
    Recombinant human growth hormone + rosiglitazone
    Interventions:
    • Drug: Rosiglitazone
    • Drug: Recombinant human growth hormone + rosiglitazone
  • Experimental: rhGH placebo + rosi
    Placebo for recombinant human growth hormone + rosiglitazone
    Interventions:
    • Drug: Rosiglitazone
    • Drug: Recombinant human growth hormone + rosiglitazone
  • Experimental: rhGH + rosi placebo
    Recombinant human growth hormone + placebo for rosiglitazone
    Interventions:
    • Drug: Rosiglitazone
    • Drug: Recombinant human growth hormone + rosiglitazone
  • Placebo Comparator: Double placebo
    Placebo for recombinant human growth hormone + placebo for rosiglitazone
    Interventions:
    • Drug: Rosiglitazone
    • Drug: Recombinant human growth hormone + rosiglitazone
Glesby MJ, Albu J, Chiu YL, Ham K, Engelson E, He Q, Muthukrishnan V, Ginsberg HN, Donovan D, Ernst J, Lesser M, Kotler DP. Recombinant human growth hormone and rosiglitazone for abdominal fat accumulation in HIV-infected patients with insulin resistance: a randomized, double-blind, placebo-controlled, factorial trial. PLoS One. 2013 Apr 12;8(4):e61160. doi: 10.1371/journal.pone.0061160. Print 2013.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
77
August 2010
August 2010   (final data collection date for primary outcome measure)

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)
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00130286
65515, R01DK065515
Yes
Marshall Jay Glesby, MD, PhD, Weill Medical College of Cornell University
Weill Medical College of Cornell University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Marshall J Glesby, MD, PhD Weill Medical College of Cornell University
Weill Medical College of Cornell University
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP