HIV Infection Clinical Trial
Official title:
Autologous Transplantation and Stem Cell-Based Gene Therapy With LVsh5/C46 (CAL-1), a Dual Anti-HIV Lentiviral Vector, for the Treatment of HIV-Associated Lymphoma
This clinical trial studies gene-modified, human immunodeficiency virus (HIV)-protected stem cell transplant in treating patients with HIV-associated lymphoma. Stem cells, or cells which help form blood, are collected from the patient and stored. They are treated in the laboratory to help protect the immune system from HIV. Chemotherapy is given before transplant to kill lymphoma cells and to make room for new stem cells to grow. Patients then receive the stem cells that were collected from them before chemotherapy and have been genetically modified to replace the stem cells killed by the chemotherapy.
PRIMARY OBJECTIVES:
I. To assess the safety and feasibility of infusing gene-modified, HIV-protected
hematopoietic stem/progenitor cells (HSPC) after high-dose chemotherapy for treatment of
acquired immune deficiency syndrome (AIDS)-related lymphoma.
II. To observe the change in gene-modified cell levels before and after antiviral treatment
interruption.
SECONDARY OBJECTIVES:
I. To evaluate the molecular and clonal composition of gene-modified cells after
hematopoietic cell transplant (HCT).
II. To describe time to disease progression, progression-free survival, treatment-related
mortality, time to neutrophil and platelet recovery, and incidence of infections.
TERTIARY OBJECTIVES:
I. To evaluate the effect of procedure on HIV-specific immune reconstitution.
II. To observe the effect of HIV infection on the presence of gene-marked cells as determined
by deoxyribonucleic (DNA) polymerase chain reaction (PCR).
OUTLINE:
CONDITIONING: Patients undergo high-dose chemotherapy or chemoradiotherapy according to
institutional guidelines.
STEM CELL INFUSION: Patients undergo hematopoietic stem cell transplant with LVsh5/C46
(Cal-1) transduced autologous CD34+ hematopoietic stem/progenitor cells (HSPC) on day 0.
Note: Patients continue to receive highly active antiretroviral therapy (HAART) throughout
treatment, with a 7-day break for apheresis. Patients may be eligible for a structured
treatment interruption of up to 12 weeks after autologous hematopoietic stem cell transplant
with gene-modified cells.
After completion of study treatment, patients are followed up periodically for 2 years, every
6 months for 3 years, and then annually for 15 years post-HCT.
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