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NCT01153646 · ClinicalTrials.gov registry record · Early Phase 1

Gene Transfer for HIV Using Autologous T Cells

A Early Phase 1 study, sponsored by City of Hope Medical Center.

Terminated
Registry status
Early Phase 1
Development phase
5
Enrollment target

NCT01153646: Clinical Trial Early Phase 1 study, sponsored by City of Hope Medical Center.

NCT01153646 is a Early Phase 1 study that was terminated before completion, run by City of Hope Medical Center. The registered enrollment target is 5 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01153646, a Early Phase 1 study, was terminated before completion, sponsored by City of Hope Medical Center.

TERMINATED
Registry status
Early Phase 1
Development phase
5 participants
Enrollment target

Study Summary

This is a pilot study to determine the safety and feasibility of lentivirus-transduced T-cell immunotherapy in patients who have failed highly active anti-retrovirus therapy (HAART).

Primary Outcome

Patient safety will be determined by clinical and laboratory observation and grading of adverse events using the CTCAE v.3. Assays: analysis of T cell repertoire clonality, and evaluation of HIV isolates for evidence of vector recombination.

Interventions

  • GENETIC pHIV7-shI-TAR-CCR5RZ treated CD4 cells

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2010-04
Est. Completion 2011-01
Phase Early Phase 1
City of Hope Medical Center

582 total trials

Why NCT01153646 stopped before completion

NCT01153646 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (91% lower).

The record links to 0 conditions, and to 1 intervention - of which pHIV7-shI-TAR-CCR5RZ treated CD4 cells is the first listed.

NCT01153646 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01153646 about?

NCT01153646 is a clinical study titled "Gene Transfer for HIV Using Autologous T Cells". This is a pilot study to determine the safety and feasibility of lentivirus-transduced T-cell immunotherapy in patients who have failed highly active anti-retrovirus therapy (HAART).

What is the current status of trial NCT01153646?

This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 5 participants. The study started on 2010-04. Estimated completion is 2011-01.

What interventions are being tested in trial NCT01153646?

The interventions under investigation include: pHIV7-shI-TAR-CCR5RZ treated CD4 cells (GENETIC).

Who is sponsoring clinical trial NCT01153646?

This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01153646's enrollment target sits among peer trials

5 1887th of 2000 higher than 80 of 2,000 other Early Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01153646, the US trial registry maintained by the National Library of Medicine. NCT01153646 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.