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A Randomized Phase II, Double-Blind, Controlled Trial to Evaluate the Safety and Efficacy of Autologous CD34+ Hematopoietic Progenitor Cells Transduced With Placebo or an Anti-HIV-1 Ribozyme (OZ1) in Patients With HIV-1 Infection
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).
Details
| Lead sponsor | Janssen-Cilag Pty Ltd |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 1 |
| Start date | 2002-12 |
| Completion | 2008-01 |
Conditions
- HIV-1
Interventions
- Placebo
- OZ1
- CD34+ cells
Primary outcomes
- Difference in viral load between the placebo and OZ1 groups. — Week 47
- Difference in viral load between the placebo and OZ1 groups. — Week 48
Countries
Australia