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OZ1

Phase 2

HIV-1 | Gene therapy | Infectious Disease |Johnson & Johnson|Last Updated: Jun 20, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment1

FDA Designations

No designations recorded

Clinical trial landscape

OZ1 · 1 trial · 1 indication

Phase 2 1
NCT00074997An Efficacy and Safety Study of Autologous Cluster of Differentiation 34 (CD34+) Hematopoietic Progenitor Cells Transduced With Placebo or an Anti- Human Immunodeficiency Virus Type 1 (HIV-1) Ribozyme (OZ1) in Participants With HIV-1 InfectionHIV-1
COMPLETED1 Analytics
PHASE2COMPLETED
An Efficacy and Safety Study of Autologous Cluster of Differentiation 34 (CD34+) Hematopoietic Progenitor Cells Transduced With Placebo or an Anti- Human Immunodeficiency Virus Type 1 (HIV-1) Ribozyme (OZ1) in Participants With HIV-1 Infection
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Study Endpoints

Primary Endpoints

Difference in viral load between the placebo and OZ1 groups.
Week 47

Secondary Endpoints

CD4+ cell count
Weeks 41 - 48
HIV proviral DNA
Weeks 41 - 48
Thymic function
Weeks 41 - 48
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
001EXPERIMENTALOZ1 Single intravenous infusion of 2-20 x 10 to the power of 7 OZ1 transduced autologous CD34+ cells per kilogram of body weight
002PLACEBO_COMPARATORPlacebo Single intravenous infusion of placebo transduced autologous CD34+ cells per kilogram of body weight

Interventions

NameTypeDescription
PlaceboOTHERSingle intravenous infusion of placebo.
OZ1GENETICSingle intravenous infusion of OZ1.
CD34+ cellsGENETICAutologous CD34+ cells.
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * An Human Immunodeficiency Virus 1 (HIV-1) infection for at least 6 months documented by positive HIV serology including confirmation by Western Blot * Receiving either the first or second regimen of antiretroviral therapy (ART) defined as 3 or more antiretroviral drugs in comb...

Countries:Australia
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Frequently asked questions about OZ1

What is OZ1 used for in HIV-1?

OZ1 is an investigational gene therapy being studied for the treatment of HIV-1 infection. It is designed to be administered to patients with HIV-1, and it has been evaluated in a clinical trial for this condition. OZ1 is not approved and remains in clinical development.

What does OZ1 target?

OZ1 is a gene therapy that uses autologous CD34+ hematopoietic progenitor cells transduced with an anti-HIV-1 ribozyme. The ribozyme is designed to target HIV-1, with the goal of inhibiting viral replication. This mechanism is being studied in patients with HIV-1 infection.

Who makes OZ1?

OZ1 is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The therapy is currently in Phase 2 clinical development for the treatment of HIV-1 infection.

What phase is OZ1 in?

OZ1 is in Phase 2 clinical development. It is an investigational gene therapy for HIV-1 infection and has not been approved by regulatory authorities. One Phase 2 clinical trial of OZ1 has been completed.

What clinical trials is OZ1 in?

OZ1 has been studied in one completed Phase 2 clinical trial, identified as NCT00074997. This trial evaluated the efficacy and safety of autologous CD34+ hematopoietic progenitor cells transduced with OZ1 in participants with HIV-1 infection. The trial was conducted in Australia.

Is OZ1 the same as OZ1 gene therapy?

OZ1 is a gene therapy that involves transducing autologous CD34+ hematopoietic progenitor cells with an anti-HIV-1 ribozyme. It is being studied as a potential treatment for HIV-1 infection and is currently in Phase 2 clinical development by Johnson & Johnson.