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
NCT00074997 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1
Last updated 2016-06-20
Summary
The purpose of this study is to determine the safety and efficacy of administration of a cell-delivered ribozyme gene transfer product to participants with chronic (lasting a long time) Human Immunodeficiency Virus Type 1 (HIV-1) infection (a life-threatening infection which you can get from an infected person's blood or from having sex with an infected person).
Conditions
Interventions
- OTHER
-
Placebo
Single intravenous infusion of placebo.
- GENETIC
-
OZ1
Single intravenous infusion of OZ1.
- GENETIC
-
CD34+ cells
Autologous CD34+ cells.
Sponsors & Collaborators
-
Janssen-Cilag Pty Ltd
lead INDUSTRY
Principal Investigators
-
Janssen-Cilag Pty Ltd Clinical Trial · Janssen-Cilag Pty Ltd
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2002-12-31
- Primary Completion
- 2008-01-31
- Completion
- 2008-01-31
Countries
- Australia
Study Locations
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