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NCT01734850 · ClinicalTrials.gov registry record · Phase 1

Safety Study of a Dual Anti-HIV Gene Transfer Construct to Treat HIV-1 Infection

A Phase 1 study, sponsored by Calimmune.

Completed
Registry status
Phase 1
Development phase
13
Enrollment target

NCT01734850: Completed Phase 1 study, sponsored by Calimmune.

NCT01734850 is a Phase 1 study that has completed, run by Calimmune. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01734850, a Phase 1 study, has completed, sponsored by Calimmune.

COMPLETED
Registry status
Phase 1
Development phase
13 participants
Enrollment target

Study Summary

This is an early phase research study looking at whether an experimental gene transfer, LVsh5/C46 (also known as Cal-1), is safe and if it can protect the immune system from the effects of HIV without the use of antiretroviral drugs. Cal-1 is an experimental gene transfer agent designed to inhibit HIV infection through 2 active parts: 1. Removing a protein named CCR5 from bone marrow and white blood cells 2. Producing a protein named C46 on bone marrow and white blood cells

Interventions

  • DRUG Busulfan
  • BIOLOGICAL Cal-1 modified HSPC
  • BIOLOGICAL Cal-1 modified CD4+ T lymphocytes

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 2013-04
Est. Completion 2017-11
Phase Phase 1
Calimmune

2 total trials

What the finished NCT01734850 record still lists

NCT01734850 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).

The record links to 0 conditions, and to 3 interventions - of which Busulfan is the first listed.

NCT01734850 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01734850 about?

NCT01734850 is a clinical study titled "Safety Study of a Dual Anti-HIV Gene Transfer Construct to Treat HIV-1 Infection". This is an early phase research study looking at whether an experimental gene transfer, LVsh5/C46 (also known as Cal-1), is safe and if it can protect the immune system from the effects of HIV without the use of antiretroviral drugs. Cal-1 is an experimental gene transfer agent designed to inhibit ...

What is the current status of trial NCT01734850?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2013-04. Estimated completion is 2017-11.

What interventions are being tested in trial NCT01734850?

The interventions under investigation include: Busulfan (DRUG), Cal-1 modified HSPC (BIOLOGICAL), Cal-1 modified CD4+ T lymphocytes (BIOLOGICAL).

Who is sponsoring clinical trial NCT01734850?

This trial is sponsored by Calimmune, which has 2 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01734850's enrollment target sits among peer trials

13 1847th of 2000 higher than 149 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 NCT01734850, the US trial registry maintained by the National Library of Medicine. NCT01734850 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.