HIV-1 Specific T -Cells (HST-NEETs) for HIV-Infected Individuals (NCT03485963) | Clinical Trial Compass
CompletedPhase 1
HIV-1 Specific T -Cells (HST-NEETs) for HIV-Infected Individuals
United States7 participantsStarted 2019-03-21
Plain-language summary
This is a phase I, multi-site, study of the safety, immunologic and virologic responses of ex vivo expanded HIV-1 multi-antigen specific T-cell therapy (HST-NEET) as a therapeutic strategy in HIV-infected individuals suppressed on antiretroviral therapy (ART).
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
Recipient Inclusion Criteria for cell procurement and cell infusion:
* ≥ 18 years and \< 65 years of age
* Confirmation of HIV-1 infection
\- any licensed ELISA test kit which is confirmed by Western blot or Multispot HIV-1/HIV-2 assay prior to screening. HIV culture, HIV antigen, plasma HIV RNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test.
* On potent antiretroviral therapy, defined as at least 2 nucleoside/nucleotide reverse transcriptase inhibitors plus a non-nucleoside reverse transcriptase inhibitor, integrase inhibitor, or a protease inhibitor without interruption (Interruption is defined as missing doses by self report for no more than two (2) consecutive days or more than four (4) cumulative days) in the 12 weeks prior to cell procurement for HST NEETs manufacturing. Other potent fully suppressive antiretroviral combinations will be considered on a case- by-case basis. Prior changes in or elimination of medications for easier dosing schedule, intolerance, toxicity, or other reasons are permitted if an alternative suppressive regimen was maintained under the compliance criteria above.
* Stable ART regimen for minimum of 12 weeks with no detectable HIV RNA concentrations as defined above. Participants may have had one or more changes in their ART regimen during the 12 week for tolerance, or dosing simplification.
* Ability and willingness of participant to continue and be compliant wit…
What they're measuring
1
Incidence of Product-Emergent Adverse Events
Timeframe: from the first day of study treatment until 28 days after the last infusion.