Autologous CD4 T-Cells in HIV (C34-CXCR4) (NCT03020524) | Clinical Trial Compass
CompletedEarly Phase 1
Autologous CD4 T-Cells in HIV (C34-CXCR4)
United States9 participantsStarted 2017-01
Plain-language summary
A single cohort, open-label pilot study of the safety and tolerability of a single infusion of autologous CD4+ T-cells genetically modified with an HR2, C34-peptide conjugated to the CXCR4 N-terminus using a lentiviral vector in HIV-infected subjects. This is a first in human study of C34-CXCR4 T cells
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to enrollment and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA VL.
* Ability and willingness of subject to provide informed consent.
* Men and women ages ≥18 years.
* Clinically stable on their first or second HAART regimen. Changes while the patient HIV viral load is undetectable does not count toward the number of ART regimens used, only changes made for virologic failure (for example an individual switching from an NNRTI-based regimen to an integrase inhibitor based regimen while the HIV viral load is undetectable will still be in their first regimen). Site investigator anticipates that a fully active alternative ART regimen could be constructed in the event of virologic failure on the current ART regimen.The current regimen should have no changes within 4 weeks of enrollment. Subjects must be willing to continue on current antiretroviral therapy for the duration of the study except for the duration of the 16 week analytical treatment interruption. (NOTE: changes to safely begin the treatment interruption are permitted).
* Screening HIV-1 RNA that is ≤50 copies/mL using a FDA-approved assay performed by any laboratory that has a CLIA certification or its equivalent within 30 days prior to enrollment…
What they're measuring
1
The Number of Subjects With Treatment Related Adverse Events