Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00074997
Status:
COMPLETED
Last Update Posted:
2016-06-20
First Post:
2003-12-28
Brief Title:
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
Sponsor:
Janssen-Cilag Pty Ltd
Organization:
Janssen-Cilag Pty Ltd
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 persons blood or from having sex with an infected person
Detailed Description:
This is a randomized study drug assigned by chance double-blind neither the participant nor the physician know the study medication drug name placebo an inactive substance that is compared with a drug to test if the drug has a real effect in a clinical trial controlled study to investigate safety and efficacy of administration of autologous cluster of differentiation 34 CD34 cells transduced with placebo or an anti-HIV-ribozyme OZ1 in participants with HIV-1 infection The total study duration will be 100 weeks and will include following visits screening pre-infusion Days 1-7 Day 8 Week 1 4 8 12 16 20 24 25 26 27 28 30 32 34 36 38 40 41 42 43 44 45 46 47 48 52 56 60 64 68 72 76 80 84 88 92 96 and 100 Before the administration of CD34 final cell product a number of procedures will be performed including the injection of granulocyte colony-stimulating factor G-CSF to mobilize the CD34 cells apheresis and the transduction of the CD34 cells with either OZ1 or placebo Participants will be divided into two groups one group will receive OZ1-containing CD34 cells the other group will receive CD34 cells alone and will receive a single intravenous infusion a fluid or a medicine delivered into a vein by way of a needle of CD34 cells transduced with either placebo or OZ1 gene transfer product The final cell product contains approximately 2-20 x 107 cellskilogram autologous CD34 cell suspension transduced with either placebo or OZ1 gene transfer product Primary efficacy will be assessed primarily by the amount of HIV ribonucleic acid RNA viral load Participants safety will be monitored throughout the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OTHOZ1-INT-1 | None | None | None |
| OZ1-HV1-201 | None | None | None |