To study overall survival. To study complete response rate and duration. To study partial response rate and duration. To study cluster of differentiation CD 4 recovery at the conclusion of the trial. To study safety in terms of toxicities, infections, transfusions, and infusion-related reactions.
To study HIV-1 viral load over time. To study persistence of vector-transduced cells over time. To evaluate the presence and the magnitude of expansion of HIV-1 resistant immune cells in the peripheral blood and gut mucosa of transplanted participants, subsequent to withholding anti-retroviral therapy ART. Patients receive BEAM regimen administered as standard of care comprising carmustine on day -6, cytarabine twice daily BID on days -5 to -2, etoposide BID on days -5 to -2, and melphalan on day After completion of study treatment, patients are followed up at days 7, 14, 21, 28, 42, 60, 90, , , , , , , , , , , and , and then yearly for at least 15 years.
Other Names:. Secondary Outcome Measures : CD4 count recovery [ Time Frame: Up to 24 months post-treatment ] At six months post-transplant, or later, ART will be voluntarily withheld for a 12 week period only for participants who have a CD4 count of or higher with no detectable viral load.
Complete response rate [ Time Frame: Up to 15 years ] Summarized descriptively. Duration of gene modified HIV-1 resistant peripheral blood cells and gut mucosal immune cells [ Time Frame: Up to 24 months post-transplant ] Summarized descriptively. Continuous measures will be summarized by mean SD and median range , with log transformation if necessary for skewed measures, as would be typical for cell counts.
In the absence of evident disease progression, response will be assessed formally at 3, 6, 12 and 24 months post transplant per study calendar. Persistence of vector-transduced cells over time [ Time Frame: Up to 15 years ] Vector stability analysis will be performed via qPRC sequencing. Presence of gene modified HIV-1 resistant peripheral blood cells and gut mucosal immune cells [ Time Frame: Up to 24 months post-transplant ] Summarized descriptively.
Quantity of gene modified HIV-1 resistant peripheral blood cells and gut mucosal immune cells [ Time Frame: Up to 24 months post-transplant ] Summarized descriptively. Working at UC Davis Health. Other UC Jobs. Enter search words Research provides a roadmap to HIV eradication via stem cell therapy. Can stem cells counteract the gut damage caused by HIV?
MSC treatments MSC treatments require well defined cell quality controls and specific delivery mechanisms. Media Contact See our media contacts page. Share this. Related Articles. New potential treatment for graft-versus-host-disease and other inflammatory disorders. We believe this type of vaccine engineering can be applied more broadly, bringing about a new day in vaccinology.
Participants received either a placebo or two doses of the vaccine compound, eOD-GT8 60mer, along with an adjuvant developed by the pharmaceutical company GSK. For more information, contact press scripps. Most of the surface not covered in sugars in red and yellow is highly variable, making it difficult for the immune system to generate antibodies capable of neutralizing the virus.
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