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 range

18 Years – 65 Years

Sex

ALL

See this in plain English?

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Insulin Sensitivity

Timeframe: 12 weeks

Trial details

NCT IDNCT00130286

SponsorWeill Medical College of Cornell University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-08

Results submitted2013-12-16

View on ClinicalTrials.gov More HIV-Associated Lipodystrophy Syndrome trials