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

Primary Purpose

HIV-Associated Lipodystrophy Syndrome, Insulin Resistance, HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Rosiglitazone
Recombinant human growth hormone + rosiglitazone
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV-Associated Lipodystrophy Syndrome focused on measuring Lipodystrophy, HIV, Growth hormone, Rosiglitazone, Visceral fat, Metabolic syndrome, Treatment Experienced, Visceral fat accumulation, fat accumulation, HIV-Associated Metabolic Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

rhGH + rosi

rhGH placebo + rosi

rhGH + rosi placebo

Double placebo

Arm Description

Recombinant human growth hormone + rosiglitazone

Placebo for recombinant human growth hormone + rosiglitazone

Recombinant human growth hormone + placebo for rosiglitazone

Placebo for recombinant human growth hormone + placebo for rosiglitazone

Outcomes

Primary Outcome Measures

Change in Insulin Sensitivity
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
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
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.

Full Information

First Posted
August 12, 2005
Last Updated
February 10, 2014
Sponsor
Weill Medical College of Cornell University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT00130286
Brief Title
Growth Hormone and/or Rosiglitazone for HIV-Associated Increased Abdominal Fat and Insulin Resistance
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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: Growth hormone (one injection, daily) PLUS rosiglitazone (one tablet, twice daily). Growth hormone PLUS rosiglitazone placebo ("sugar pill"). Growth hormone placebo (plain water injection) PLUS rosiglitazone. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV-Associated Lipodystrophy Syndrome, Insulin Resistance, HIV Infections, Metabolic Syndrome X, Body Weight Changes
Keywords
Lipodystrophy, HIV, Growth hormone, Rosiglitazone, Visceral fat, Metabolic syndrome, Treatment Experienced, Visceral fat accumulation, fat accumulation, HIV-Associated Metabolic Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rhGH + rosi
Arm Type
Experimental
Arm Description
Recombinant human growth hormone + rosiglitazone
Arm Title
rhGH placebo + rosi
Arm Type
Experimental
Arm Description
Placebo for recombinant human growth hormone + rosiglitazone
Arm Title
rhGH + rosi placebo
Arm Type
Experimental
Arm Description
Recombinant human growth hormone + placebo for rosiglitazone
Arm Title
Double placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for recombinant human growth hormone + placebo for rosiglitazone
Intervention Type
Drug
Intervention Name(s)
Rosiglitazone
Intervention Description
4 mg tablet twice a day x 12 weeks (double-blind phase)
Intervention Type
Drug
Intervention Name(s)
Recombinant human growth hormone + rosiglitazone
Intervention Description
Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)
Primary Outcome Measure Information:
Title
Change in Insulin Sensitivity
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in Visceral Adipose Tissue Volume
Description
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.
Time Frame
12 weeks
Title
Change in Subcutaneous Adipose Tissue Volume
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marshall J Glesby, MD, PhD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
AIDS Community Research Initiative of America (ACRIA)
City
New York
State/Province
New York
ZIP/Postal Code
10018
Country
United States
Facility Name
Cornell HIV Clinical Trials Unit, Weill Medical College of Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
St. Luke's-Roosevelt Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Facility Name
Columbia University College of Physicians and Surgeons
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23593417
Citation
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.
Results Reference
result
PubMed Identifier
25536669
Citation
Kotler DP, He Q, Engelson ES, Albu JB, Glesby MJ. The effect of recombinant human growth hormone with or without rosiglitazone on hepatic fat content in HIV-1-infected individuals: a randomized clinical trial. Antivir Ther. 2016;21(2):107-16. doi: 10.3851/IMP2927. Epub 2014 Dec 23.
Results Reference
derived

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

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