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

February 10, 2014 updated by: Marshall Jay Glesby, MD, PhD, Weill Medical College of Cornell University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10025
        • St. Luke's-Roosevelt Hospital Center
      • New York, New York, United States, 10032
        • Columbia University College of Physicians and Surgeons
      • New York, New York, United States, 10018
        • AIDS Community Research Initiative of America (ACRIA)
      • New York, New York, United States, 10021
        • Cornell HIV Clinical Trials Unit, Weill Medical College of Cornell University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Insulin Sensitivity
Time Frame: 12 weeks

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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Visceral Adipose Tissue Volume
Time Frame: 12 weeks

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.
12 weeks
Change in Subcutaneous Adipose Tissue Volume
Time Frame: 12 weeks

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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Marshall J Glesby, MD, PhD, Weill Medical College of Cornell University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

August 12, 2005

First Submitted That Met QC Criteria

August 12, 2005

First Posted (Estimate)

August 15, 2005

Study Record Updates

Last Update Posted (Estimate)

February 13, 2014

Last Update Submitted That Met QC Criteria

February 10, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 65515
  • R01DK065515 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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