drugset / Trial / NCT00071240
Growth Hormone to Increase Immune Function in People With HIV
Phase 2
Completed
22 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
EMD Serono · collabNational Center for Research Resources (NCRR) · collabThe J. David Gladstone Institutes · collabUniversity of California, San Francisco · collab
RandomizedCrossoverOpen-labelTreatment
Summary
Growth hormone plays an important role in the development of the immune system. Studies suggest that growth hormone may promote growth of the thymus, a gland responsible for the production of important immune cells called T cells. Since these cells are lost during the course of HIV infection, it is possible that growth hormone treatment could help restore the immune system. This study will determine whether the administration of growth hormone can increase the size and function of the thymus and cause an increase in the number of new T cells in the blood of people infected with HIV. Study hypothesis: Growth hormone treatment will enhance T cell production in HIV infected adults.
Timeline
- Start
- 2002-10
- Primary completion
- 2007-09
- Completion
- 2007-09
Publications
- Background Napolitano LA, Lo JC, Gotway MB, Mulligan K, Barbour JD, Schmidt D, Grant RM, Halvorsen RA, Schambelan M, McCune JM. Increased thymic mass and circulating naive CD4 T cells in HIV-1-infected adults treated with growth hormone. AIDS. 2002 May 24;16(8):1103-11. doi: 10.1097/00002030-200205240-00003.
- Results Napolitano LA, Schmidt D, Gotway MB, Ameli N, Filbert EL, Ng MM, Clor JL, Epling L, Sinclair E, Baum PD, Li K, Killian ML, Bacchetti P, McCune JM. Growth hormone enhances thymic function in HIV-1-infected adults. J Clin Invest. 2008 Mar;118(3):1085-98. doi: 10.1172/JCI32830.
- Results Tesselaar K, Miedema F. Growth hormone resurrects adult human thymus during HIV-1 infection. J Clin Invest. 2008 Mar;118(3):844-7. doi: 10.1172/JCI35112.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Somatropin | Protein / enzyme biologic | 1.5 mg | Subcutaneous |