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NCT00000756 · ClinicalTrials.gov registry record · Phase 1

Evaluation of the Safety and Tolerance of Immunotherapy With Autologous, Ex-Vivo Expanded, HIV-Specific Cytotoxic T-Cells in HIV-Infected Patients With CD4+ Counts Between 100-400/mm3

A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 1
Development phase
15
Enrollment target

NCT00000756: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT00000756 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00000756, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
15 participants
Enrollment target

Study Summary

To determine the safety, tolerance, and feasibility of adoptive immunotherapy with autologous cytotoxic T-lymphocytes (CTLs) in HIV-infected patients with CD4 counts between 100 and 400; to evaluate the immunologic, virologic, and clinical changes for up to 24 weeks following infusion of study therapy. Freshly isolated peripheral blood lymphocytes from HIV-1-seropositive individuals frequently lyse autologous HIV-1-expressing cells or autologous cells infected with vaccinia vectors encoding HIV-1-specific proteins. Administration of these cytotoxic T lymphocytes (CTLs) may help prevent HIV disease progression.

Interventions

  • DRUG Lymphocytes, Activated

Trial Details

FieldValue
Enrollment Target 15 participants
Est. Completion 2002-06
Phase Phase 1

What the finished NCT00000756 record still lists

NCT00000756 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).

The record links to 0 conditions, and to 1 intervention - of which Lymphocytes, Activated is the first listed.

NCT00000756 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00000756 about?

NCT00000756 is a clinical study titled "Evaluation of the Safety and Tolerance of Immunotherapy With Autologous, Ex-Vivo Expanded, HIV-Specific Cytotoxic T-Cells in HIV-Infected Patients With CD4+ Counts Between 100-400/mm3". To determine the safety, tolerance, and feasibility of adoptive immunotherapy with autologous cytotoxic T-lymphocytes (CTLs) in HIV-infected patients with CD4 counts between 100 and 400; to evaluate the immunologic, virologic, and clinical changes for up to 24 weeks following infusion of study thera...

What is the current status of trial NCT00000756?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. Estimated completion is 2002-06.

What interventions are being tested in trial NCT00000756?

The interventions under investigation include: Lymphocytes, Activated (DRUG).

Who is sponsoring clinical trial NCT00000756?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00000756's enrollment target sits among peer trials

15 1798th of 2000 higher than 157 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 NCT00000756, the US trial registry maintained by the National Library of Medicine. NCT00000756 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.