Safety and Efficacy of T Cell Genetic Immunotherapy for HIV
|ClinicalTrials.gov Identifier: NCT00131560|
Recruitment Status : Active, not recruiting
First Posted : August 18, 2005
Last Update Posted : June 8, 2011
Information provided by:
No Study Results Posted on ClinicalTrials.gov for this Study
|Recruitment Status :||Active, not recruiting|
|Actual Primary Completion Date :||November 2008|
|Estimated Study Completion Date :||June 2023|
Manilla P, Rebello T, Afable C, Lu X, Slepushkin V, Humeau LM, Schonely K, Ni Y, Binder GK, Levine BL, MacGregor RR, June CH, Dropulic B. Regulatory considerations for novel gene therapy products: a review of the process leading to the first clinical lentiviral vector. Hum Gene Ther. 2005 Jan;16(1):17-25. Review. Erratum in: Hum Gene Ther. 2006 Feb;17(2):252. Hum Gene Ther. 2005 Feb;16(2):279.
Ni Y, Sun S, Oparaocha I, Humeau L, Davis B, Cohen R, Binder G, Chang YN, Slepushkin V, Dropulic B. Generation of a packaging cell line for prolonged large-scale production of high-titer HIV-1-based lentiviral vector. J Gene Med. 2005 Jun;7(6):818-34. Erratum in: J Gene Med. 2005 Jun;7(6):835.
Lu X, Humeau L, Slepushkin V, Binder G, Yu Q, Slepushkina T, Chen Z, Merling R, Davis B, Chang YN, Dropulic B. Safe two-plasmid production for the first clinical lentivirus vector that achieves >99% transduction in primary cells using a one-step protocol. J Gene Med. 2004 Sep;6(9):963-73.
Lu X, Yu Q, Binder GK, Chen Z, Slepushkina T, Rossi J, Dropulic B. Antisense-mediated inhibition of human immunodeficiency virus (HIV) replication by use of an HIV type 1-based vector results in severely attenuated mutants incapable of developing resistance. J Virol. 2004 Jul;78(13):7079-88.
Humeau LM, Binder GK, Lu X, Slepushkin V, Merling R, Echeagaray P, Pereira M, Slepushkina T, Barnett S, Dropulic LK, Carroll R, Levine BL, June CH, Dropulic B. Efficient lentiviral vector-mediated control of HIV-1 replication in CD4 lymphocytes from diverse HIV+ infected patients grouped according to CD4 count and viral load. Mol Ther. 2004 Jun;9(6):902-13.