Safety Study of a Dual Anti-HIV Gene Transfer Construct to Treat HIV-1 Infection
Completed · Phase 1, Phase 2 · NCT01734850
Conditions: Human Immunodeficiency Virus
At a glance
- Research payments reported, 2025
- $12,287
- U.S. investigators named
- 2
- Sites paid
- 2
- Planned or actual enrollment
- 13
About the trial
- Sponsor
- Calimmune, Inc.
- Tested
- Busulfan (drug), Cal-1 modified HSPC (biological), Cal-1 modified CD4+ T lymphocytes (biological)
- Dates
- Started 2013-04; completion 2017-11
- Results posted
- Yes
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
From ClinicalTrials.gov, last updated 2020-08-06. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Csl Behring reported $12,287 in research payments for this study in 2025 (12 payments).
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Jacob Lalezari, M.D. Internal Medicine · San Francisco, CA
- Raphael J. Landovitz, MD Infectious Disease · Los Angeles, CA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Quest Clinical Research $8,830
- Ronald Reagan UCLA Medical Center, CA $3,457
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.