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

NCT01734850 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2020-08-06

Study results available
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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

Conditions

  • Human Immunodeficiency Virus

Interventions

DRUG

Busulfan

Intravenous busulfan

BIOLOGICAL

Cal-1 modified HSPC

Hematopoietic progenitor/stem cells (HSPC) modified with LVsh5/C46 (Cal-1)

BIOLOGICAL

Cal-1 modified CD4+ T lymphocytes

CD4+ T lymphocytes modified with LVsh5/C46 (Cal-1)

Sponsors & Collaborators

  • Calimmune, Inc.

    lead INDUSTRY

Principal Investigators

  • Ronald Mitsuyasu, M.D. · University of California, Los Angeles

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2017-09-30
Completion
2017-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01734850 on ClinicalTrials.gov