Official Title: “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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2010

A number of people with HIV infection who gain weight in the abdomen (sometimes called lipodystrophy) also have a high level of the sugar-controlling hormone called insulin. These people need to produce this extra insulin to help keep their blood sugar normal. This is called "insulin resistance."

Studies have shown that growth hormone (also called "Serostim") can decrease abdominal fat, but it can also worsen the insulin resistance.

Rosiglitazone (also called "Avandia") is used to treat insulin resistance in people who have diabetes, so we want to see if taking growth hormone and rosiglitazone together will be better for treating the fat accumulation part of lipodystrophy than either drug alone or no active therapy.

The study is 24 weeks long, divided into two 12-week parts.

The first part of the study is double-blind, meaning that neither participants nor the study staff will know which drugs participants are on.

Participants will be assigned randomly (like flipping a coin) to one of four groups:

1. Growth hormone (one injection, daily) PLUS rosiglitazone (one tablet, twice daily).

2. Growth hormone PLUS rosiglitazone placebo ("sugar pill").

3. Growth hormone placebo (plain water injection) PLUS rosiglitazone.

4. Growth hormone placebo PLUS rosiglitazone placebo.

Everyone in the study will need to be hospitalized overnight for special tests at the beginning of the study and at week 12.

The second part of the study is open-label, meaning that participants and the study staff will know which drugs participants are receiving. All volunteers will receive both active drugs: - Growth hormone (one 2 mg injection, every other day) PLUS rosiglitazone (one 4 mg tablet, twice daily).

Intervention(s) in this Clinical Trial

• Drug: Recombinant Human Growth Hormone
  • 3 mg subcutaneous injection daily for 12 weeks (double-blind phase)
• Drug: Rosiglitazone
  • 4 mg tablet twice a day x 12 weeks (double-blind phase)
• Drug: Recombinant Human Growth Hormone and Rosiglitazone
  • 3mg subcutaneous injection of the Human Growth Hormone daily plus 4 mg Rosiglitazone tablet twice daily x 12 weeks (double-blind phase)
• Drug: Placebo human growth hormone and placebo rosiglitazone
  • Placebo subcutaneous injections daily plus placebo pills twice daily for 12 weeks (double-blind phase)

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Experimental: 2
• Experimental: 3
• Placebo Comparator: 4

Primary Measures

• Change in insulin sensitivity
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• Change in body fat (total and regional; visceral and subcutaneous)
  • Time Frame: 12 weeks
    Safety Issue?: No
• Other body composition and metabolic endpoints
  • Time Frame: 12 weeks
    Safety Issue?: No

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)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Overall Clinical Trial Officials and Contacts

Marshall J Glesby, MD, PhD Principal Investigator Weill Medical College of Cornell University  

Overall Contact: Kirsis Ham, MSN, FNP 212-746-4166 kah2003@med.cornell.edu

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00130286

Study ID Number: 65515

ClinicalTrials.gov Identifier: NCT00130286

Health Authority: United States: Federal Government