A pilot study of the safety and efficacy of thymosin<i>α</i>1 in augmenting immune reconstitution in HIV-infected patients with low CD4 counts taking highly active antiretroviral therapy
David Chadwick, Jeffrey Pido-Lopez, António Pires et al.
Research Article — Peer-Reviewed Source
Original research published by Chadwick et al. in Clinical & Experimental Immunology. Redistributed under Open Access — see publisher for license terms. MedTech Research Group provides these references for informational purposes. We do not conduct original research. All studies are the work of their respective authors and institutions.
To study the safety and efficacy of thymosin alpha1 in stimulating immune reconstitution in combination with highly active antiretroviral therapy (HAART), a phase II randomized, controlled open-label trial of subcutaneous thymosin alpha1 was undertaken for 12 weeks. Twenty clinically stable patients with viral loads <400 copies/ml and CD4 counts less than 200 cells/microl were randomized to receive 3.2 mg thymosin alpha 1 subcutaneous injections twice weekly or no injections for 12 weeks. CD4 and CD8 counts, CD45 RO+ and RA+ subsets and signal joint T cell receptor excision circles (sjTREC) in peripheral blood mononuclear cells (PBMCs) were measured every 2 weeks. Thirteen patients received thymosin alpha 1 and seven were controls. Thymosin alpha 1 was well tolerated and there were no serious adverse events. There was no significant difference between the thymosin alpha1 and control groups in CD4, CD8 and CD45 lymphocyte subset changes at week 12; however, PBMC sjTREC levels increased significantly in the thymosin alpha 1-treated patients compared to controls at week 12. In conclusion, the increase in PBMC sjTREC levels in patients taking thymosin alpha1 may represent enhanced immune reconstitution; however, the clinical benefits and long-term consequences remain to be determined.
Abstract
To study the safety and efficacy of thymosin α 1 in stimulating immune reconstitution in combination with highly active antiretroviral therarpy (HAART), a phase II randomized, controlled open-label trial of subcutaneous thymosin α 1 was undertaken for 12 weeks. Twenty clinically stable patients with viral loads <400 copies/ml and CD4 counts less than 200 cells/ µ l were randomized to receive 3·2 mg thymosin α 1 subcutaneous injections twice weekly or no injections for 12 weeks. CD4 and CD8 counts, CD45 RO + and RA + subsets and signal joint T cell receptor excision circles (sjTREC) in peripheral blood mononuclear cells (PBMCs) were measured every 2 weeks. Thirteen patients received thymosin α 1 and seven were controls. Thymosin α 1 was well tolerated and there were no serious adverse events. There was no significant difference between the thymosin α 1 and control groups in CD4, CD8 and CD45 lymphocyte subset changes at week 12; however, PBMC sjTREC levels increased significantly in the thymosin α 1 -treated patients compared to controls at week 12. In conclusion, the increase in PBMC sjTREC levels in patients taking thymosin α 1 may represent enhanced immune reconstitution; however, the clinical benefits and long-term consequences remain to be determined.
| DOI | 10.1111/j.1365-2249.2003.02331.x |
| PubMed ID | 14632754 |
| PMC ID | PMC1808897 |
| Journal | Clinical & Experimental Immunology |
| Year | 2003 |
| Authors | David Chadwick, Jeffrey Pido-Lopez, António Pires, Nesrina Imami, F Gotch, Jorge Villacian, S RAVINDRAN, N.I.J. Paton |
| License | Open Access — see publisher for license terms |
| Citations | 39 |