At a glance
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A Phase I Study of Stem Cell Gene Therapy for HIV Mediated by Lentivector Transduced, Pre-Selected CD34+ Cells
In Brief
A Phase 2 clinical trial evaluating Autologous Hematopoietic Stem Cell Transplantation, Carmustine, and 6 other interventions for HIV Infection and 10 related conditions. Active but no longer recruiting, targeting 11 participants across 4 sites.
Detailed Summary
This phase I/II trial studies the side effects and best dose of gene therapy in treating patients with human immunodeficiency virus (HIV)-related lymphoma that did not respond to therapy or came back after an original response receiving stem cell transplant. In gene therapy, small stretches of deoxyribonucleic acid (DNA) called "anti-HIV genes" are introduced into the stem cells in the laboratory to make the gene therapy product used in this study. The type of anti-HIV genes and therapy in this study may make the patient's immune cells more resistant to HIV-1 and prevent new immune cells from getting infected with HIV-1.
Study Details
Timeline
Interventions
Undergo infusion of lentivirus vector CCR5 shRNA/TRIM5alpha/TAR decoy-transduced autologous CD34-positive hematopoietic progenitor cells
300 mg/m2 on Day -6, as part of BEAM and R-BEAM regimens.
100 mg/m2 BID on Days -5 through -2, as part of BEAM and R-BEAM regimens.
VP-16: 100 mg/m2 BID on Days -5 through -2, as part of BEAM and R-BEAM regimens.
Correlative studies
Undergo infusion of lentivirus vector CCR5 shRNA/TRIM5alpha/TAR decoy-transduced autologous CD34-positive hematopoietic progenitor cells
140 mg/m2 on Day -1, as part of BEAM and R-BEAM regimens.
Undergo infusion of lentivirus vector CCR5 shRNA/TRIM5alpha/TAR decoy-transduced autologous CD34-positive hematopoietic progenitor cells