drugset / Trial / NCT01734850
Safety Study of a Dual Anti-HIV Gene Transfer Construct to Treat HIV-1 Infection
Non-randomizedParallel-groupOpen-labelTreatment
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
Timeline
- Start
- 2013-04
- Primary completion
- 2017-09
- Completion
- 2017-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cal-1 modified CD4+ T lymphocytes | Unknown | — | — |
| Subject | Cal-1 modified HSPC | Unknown | — | — |
| Background | Busulfan | Small molecule | 4 mg/kg | Intravenous |