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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2013-04 |
| Est. Completion | 2017-11 |
| Phase | Phase 1 |
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.
Learn More About Clinical Trials
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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