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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 is a Phase 1 study that has completed, run by Calimmune. The registered enrollment target is 13 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01734850
The ClinicalTrials.gov registry entry for NCT01734850 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Calimmune, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Busulfan is the first listed.
NCT01734850 reports 0 study locations.
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.
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