Overview

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

Status:
Completed
Trial end date:
2010-08-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Weill Medical College of Cornell University
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Treatments:
Hormones
Rosiglitazone
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)