Growth Hormone and/or Rosiglitazone for HIV-Associated Increased Abdominal Fat and Insulin Resist… (NCT00130286) | Clinical Trial Compass
CompletedPhase 1/2
Growth Hormone and/or Rosiglitazone for HIV-Associated Increased Abdominal Fat and Insulin Resistance
United States77 participantsStarted 2005-03
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 (Marino…
What they're measuring
1
Change in Insulin Sensitivity
Timeframe: 12 weeks
Trial details
NCT IDNCT00130286
SponsorWeill Medical College of Cornell University