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
2 other identifiers
interventional
77
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2005
Longer than P75 for phase_1
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 12, 2005
CompletedFirst Posted
Study publicly available on registry
August 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedResults Posted
Study results publicly available
February 13, 2014
CompletedFebruary 13, 2014
February 1, 2014
5.4 years
August 12, 2005
December 16, 2013
February 10, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
12 weeks
Secondary Outcomes (2)
Change in Visceral Adipose Tissue Volume
12 weeks
Change in Subcutaneous Adipose Tissue Volume
12 weeks
Study Arms (4)
rhGH + rosi
EXPERIMENTALRecombinant human growth hormone + rosiglitazone
rhGH placebo + rosi
EXPERIMENTALPlacebo for recombinant human growth hormone + rosiglitazone
rhGH + rosi placebo
EXPERIMENTALRecombinant human growth hormone + placebo for rosiglitazone
Double placebo
PLACEBO COMPARATORPlacebo for recombinant human growth hormone + placebo for rosiglitazone
Interventions
4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
AIDS Community Research Initiative of America (ACRIA)
New York, New York, 10018, United States
Cornell HIV Clinical Trials Unit, Weill Medical College of Cornell University
New York, New York, 10021, United States
St. Luke's-Roosevelt Hospital Center
New York, New York, 10025, United States
Columbia University College of Physicians and Surgeons
New York, New York, 10032, United States
Related Publications (2)
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.
PMID: 23593417RESULTKotler 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.
PMID: 25536669DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Marshall J. Glesby
- Organization
- Weill Cornell Medical College
Study Officials
- PRINCIPAL INVESTIGATOR
Marshall J Glesby, MD, PhD
Weill Medical College of Cornell University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine and Public Health
Study Record Dates
First Submitted
August 12, 2005
First Posted
August 15, 2005
Study Start
March 1, 2005
Primary Completion
August 1, 2010
Study Completion
August 1, 2010
Last Updated
February 13, 2014
Results First Posted
February 13, 2014
Record last verified: 2014-02