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NCT01013415 · ClinicalTrials.gov registry record · Phase 1

CD4-ZETA Gene Modified T Cells With and Without Exogenous Interleukin-2 (IL-2) In HIV Patients

A Phase 1 study, sponsored by University of Pennsylvania.

Completed
Registry status
Phase 1
Development phase
17
Enrollment target

NCT01013415: Completed Phase 1 study, sponsored by University of Pennsylvania.

NCT01013415 is a Phase 1 study that has completed, run by University of Pennsylvania. The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT01013415, a Phase 1 study, has completed, sponsored by University of Pennsylvania.

COMPLETED
Registry status
Phase 1
Development phase
17 participants
Enrollment target

Study Summary

The purpose of this study is to find out the safety and activity of an experimental anti-HIV treatment using autologous CD4-zeta gene-changed T cells and/or IL-2 (recombinant interleukin2).

Primary Outcome

To assess and compare the safety of each arm when comparing related adverse events reported of subjects on study through the end of study (week 54).

Interventions

  • DRUG HAART
  • BIOLOGICAL T cells

Trial Details

FieldValue
Enrollment Target 17 participants
Start Date 2001-09
Est. Completion 2021-08
Phase Phase 1
University of Pennsylvania

1,423 total trials

What the finished NCT01013415 record still lists

NCT01013415 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).

The record links to 0 conditions, and to 2 interventions - of which HAART is the first listed.

NCT01013415 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01013415 about?

NCT01013415 is a clinical study titled "CD4-ZETA Gene Modified T Cells With and Without Exogenous Interleukin-2 (IL-2) In HIV Patients". The purpose of this study is to find out the safety and activity of an experimental anti-HIV treatment using autologous CD4-zeta gene-changed T cells and/or IL-2 (recombinant interleukin2).

What is the current status of trial NCT01013415?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2001-09. Estimated completion is 2021-08.

What interventions are being tested in trial NCT01013415?

The interventions under investigation include: HAART (DRUG), T cells (BIOLOGICAL).

Who is sponsoring clinical trial NCT01013415?

This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01013415's enrollment target sits among peer trials

17 1785th of 2000 higher than 215 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other 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 NCT01013415, the US trial registry maintained by the National Library of Medicine. NCT01013415 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.