A Long Term Follow-up Protocol to Evaluate the Safety and Survival of Autologous CD34+ Hematopoietic Progenitor Cells Transduced With an Anti-HIV-1 Ribozyme (OZ1) in Patients With HIV-1 Infection
During an earlier phase 2 base trial (study # NCT00074997), HIV-1 infected patients received
a gene therapy product (anti-HIV-1 Ribozyme [OZ1]). Gene therapy is an investigational
treatment where genes are inserted into an individual's cells and tissues to treat a
disease. The gene therapy OZ1 is thought to have anti-HIV-1 actions. This is an
Observational Study to provide long term follow-up of those HIV-1 infected patients who
received the gene therapy product (anti-HIV-1 Ribozyme [OZ1]) as part of the earlier study.
Patients are seen twice yearly until 5 years from initial infusion of study drug has elapsed
and then yearly for the rest of their lives. The study will monitor for and record any ill
effects from the gene therapy product to provide long term safety information. Observational
study - no investigational drug administered.
Adverse events, reportable events such as cancers and deaths
Lifetime of the patient. Each patient will have visits every 6 months until 5 years post infusion, then annual visits for safety assessments, until their death.
Janssen-Cilag Pty Ltd Clinical Trial
Janssen-Cilag Pty Ltd
United States: Food and Drug Administration
|Fountain Valley, California 92708|
|Albany, New York 12208|