drugset / Trial / NCT00130286
Growth Hormone and/or Rosiglitazone for HIV-Associated Increased Abdominal Fat and Insulin Resistance
Phase 1/2
Completed
77 enrolled
Weill Medical College of Cornell University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collab
RandomizedFactorialQuadruple-blindTreatment
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.
Timeline
- Start
- 2005-03
- Primary completion
- 2010-08
- Completion
- 2010-08
Publications
- Results Glesby MJ, Albu J, Chiu YL, Ham K, Engelson E, He Q, Muthukrishnan V, Ginsberg HN, Donovan D, Ernst J, Lesser M, Kotler DP. Recombinant human growth hormone and rosiglitazone for abdominal fat accumulation in HIV-infected patients with insulin resistance: a randomized, double-blind, placebo-controlled, factorial trial. PLoS One. 2013 Apr 12;8(4):e61160. doi: 10.1371/journal.pone.0061160. Print 2013.
- Kotler DP, He Q, Engelson ES, Albu JB, Glesby MJ. The effect of recombinant human growth hormone with or without rosiglitazone on hepatic fat content in HIV-1-infected individuals: a randomized clinical trial. Antivir Ther. 2016;21(2):107-16. doi: 10.3851/IMP2927. Epub 2014 Dec 23.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rosiglitazone | Small molecule | 4 mg | Oral |
| Subject | Somatropin | Protein / enzyme biologic | 3 mg | Subcutaneous |