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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00130286 |
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Date of registration:
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12/08/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Growth Hormone and/or Rosiglitazone for HIV-Associated Increased Abdominal Fat and Insulin Resistance
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Scientific title:
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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 |
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Date of first enrolment:
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March 2005 |
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Target sample size:
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77 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00130286 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Marshall J Glesby, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Weill Medical College of Cornell University |
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Key inclusion & exclusion criteria
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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)
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Body Weight Changes
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HIV Infections
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HIV-Associated Lipodystrophy Syndrome
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Insulin Resistance
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Metabolic Syndrome X
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Intervention(s)
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Drug: Rosiglitazone
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Drug: Recombinant human growth hormone + rosiglitazone
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Primary Outcome(s)
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Change in Insulin Sensitivity
[Time Frame: 12 weeks]
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Secondary Outcome(s)
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Change in Subcutaneous Adipose Tissue Volume
[Time Frame: 12 weeks]
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Change in Visceral Adipose Tissue Volume
[Time Frame: 12 weeks]
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Secondary ID(s)
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65515
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R01DK065515
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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