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| Sponsored by: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
|---|---|
| Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| ClinicalTrials.gov Identifier: | NCT00130286 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV-Associated Lipodystrophy Syndrome Insulin Resistance HIV Infections Metabolic Syndrome X Body Weight Changes |
Drug: Recombinant Human Growth Hormone Drug: Rosiglitazone Drug: Recombinant Human Growth Hormone and Rosiglitazone Drug: Placebo human growth hormone and placebo rosiglitazone |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 80 |
| Study Start Date: | March 2005 |
| Estimated Study Completion Date: | January 2010 |
| Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
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)
|
| 2: Experimental |
Drug: Recombinant Human Growth Hormone
3 mg subcutaneous injection daily for 12 weeks (double-blind phase)
|
| 3: Experimental |
Drug: Rosiglitazone
4 mg tablet twice a day x 12 weeks (double-blind phase)
|
| 4: Placebo Comparator |
Drug: Placebo human growth hormone and placebo rosiglitazone
Placebo subcutaneous injections daily plus placebo pills twice daily for 12 weeks (double-blind phase)
|
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:
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:
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Within 12 weeks of study entry, use of the following:
Contacts and Locations| Contact: Kirsis Ham, MSN, FNP | 212-746-4166 | kah2003@med.cornell.edu |
| Contact: Valery Hughes, FNP | 212-746-4393 | vah9001@med.cornell.edu |
| United States, New York | |
| Cornell HIV Clinical Trials Unit, Weill Medical College of Cornell University | Recruiting |
| New York, New York, United States, 10021 | |
| Contact: Kirsis Ham, MSN, CFNP 212-746-4166 kah9003@med.cornell.edu | |
| Contact: Valery Hughes, FNP 212-746-4393 vah9001@med.cornell.edu | |
| Principal Investigator: Marshall J Glesby, MD, PhD | |
| St. Luke's-Roosevelt Hospital Center | Recruiting |
| New York, New York, United States, 10025 | |
| Contact: Janet Sheikhan, RN 212-523-3671 | |
| Contact: Ellen Engelson, Ed.D. 212-523-3670 | |
| Principal Investigator: Donald Kotler, MD | |
| Columbia University College of Physicians and Surgeons | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Carlos Lopez, MD 212-305-2920 | |
| Principal Investigator: Daniel Donovan, MD, MSc | |
| Sub-Investigator: Michael Yin, MD, MSc | |
| AIDS Community Research Initiative of America (ACRIA) | Recruiting |
| New York, New York, United States, 10018 | |
| Contact: Yuriy Akulov, MD 212-924-3934 ext 124 yakulov@acria.org | |
| Contact: Liza Kelly-Rossini, NP 212-924-3934 ext 125 lkelly@acria.org | |
| Principal Investigator: | Marshall J Glesby, MD, PhD | Weill Medical College of Cornell University |
More Information
| Responsible Party: | Weill Cornell Medical College ( Marshall J Glesby, MD, PHD/Principal Investigator ) |
| Study ID Numbers: | 65515 |
| Study First Received: | August 12, 2005 |
| Last Updated: | April 7, 2009 |
| ClinicalTrials.gov Identifier: | NCT00130286 History of Changes |
| Health Authority: | United States: Federal Government |
|
Lipodystrophy HIV Growth hormone Rosiglitazone Visceral fat |
Metabolic syndrome Treatment Experienced Visceral fat accumulation fat accumulation HIV-Associated Metabolic Syndrome |
|
Sexually Transmitted Diseases, Viral Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Insulin Body Weight Signs and Symptoms Hyperinsulinism Hypoglycemic Agents Lipodystrophy Body Weight Changes Retroviridae Infections Metabolic Disorder Rosiglitazone |
Obesity Metabolic Syndrome X Metabolic Diseases Skin Diseases Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes Abdominal Obesity Metabolic Syndrome Virus Diseases HIV-Associated Lipodystrophy Syndrome HIV Infections Sexually Transmitted Diseases Insulin Resistance Glucose Metabolism Disorders Lipid Metabolism Disorders |
|
Sexually Transmitted Diseases, Viral Slow Virus Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Infection Hormones Body Weight Signs and Symptoms Hyperinsulinism Hypoglycemic Agents Pathologic Processes Syndrome Lipodystrophy Body Weight Changes Rosiglitazone |
Retroviridae Infections RNA Virus Infections Disease Metabolic Syndrome X Metabolic Diseases Immune System Diseases Skin Diseases Acquired Immunodeficiency Syndrome Pharmacologic Actions Immunologic Deficiency Syndromes Virus Diseases HIV-Associated Lipodystrophy Syndrome HIV Infections Skin Diseases, Metabolic Sexually Transmitted Diseases |
