Overview

This trial is active, not recruiting.

Condition hiv-1
Treatment oz1 transduced cells
Phase phase 2
Sponsor Janssen-Cilag Pty Ltd
Start date December 2004
End date December 2020
Trial size 37 participants
Trial identifier NCT01177059, CR016027, OZ1-HV1-202

Summary

The purpose of this Observational Study is long term follow-up of the Human Immunodeficiency Virus -1 (HIV-1) infected patients who have received a gene therapy product (anti-HIV-1 Ribozyme [OZ1]) as part of an earlier phase 2 trial. 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Arm
(Other)
OZ1 transduced cells Long term follow up of previously infused OZ1 transduced cells
oz1 transduced cells
Long term follow up of previously infused OZ1 transduced cells

Primary Outcomes

Measure
Adverse events, reportable events such as cancers and deaths
time frame: 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.

Secondary Outcomes

Measure
Clonal expansion of cells with a predominant OZ1 insertion site
time frame: Lifelong follow-up
Assess quantitative marking of the gene transfer product in peripheral blood mononuclear cells (PBMC) over time
time frame: For a minimum of 15 years

Eligibility Criteria

Male or female participants from 18 years up to 45 years old.

Inclusion Criteria: - Patients must have received the Final Cell Product infusion in base study - Have signed Informed Consent Form Exclusion Criteria: - Any patient from the base study that was assigned to the placebo arm

Additional Information

Official title 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
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Janssen-Cilag Pty Ltd.