drugset / Trial / NCT01734850

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

NCT01734850

Phase 1/2 Completed 13 enrolled Calimmune, Inc.
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

EvaluationDrugModalityDoseRoute
Subject Cal-1 modified CD4+ T lymphocytes Unknown
Subject Cal-1 modified HSPC Unknown
Background Busulfan Small molecule 4 mg/kg Intravenous