Long Term Follow-Up Study of Human Immunodeficiency Virus Type 1 (HIV-1) Positive Patients Who Have Received OZ1 Gene Therapy as Part of a Clinical Trial
| Status: | Completed |
|---|---|
| Conditions: | HIV / AIDS, HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 12/14/2018 |
| Start Date: | December 6, 2004 |
| End Date: | November 30, 2017 |
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
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 until withdrawal or
study completion. The study will monitor for and record any ill effects from the gene therapy
product to provide long term safety information.
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 until withdrawal or
study completion. The study will monitor for and record any ill effects from the gene therapy
product to provide long term safety information.
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 until
withdrawal or study completion. 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.
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 until
withdrawal or study completion. 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.
Inclusion Criteria:
- All patients who were enrolled (between 18 and 45 years of age) in the base study
"OTH/OZ1-INT-1" (NCT00074997) will be invited to participate in this long term
follow-up study
- Patients must have received the Final Cell Product infusion in base study
"OTH/OZ1-INT-1"
- Have signed Informed Consent Form
Exclusion Criteria:
- All patients who were enrolled in the OTH/OZ1-INT-1 study and received the final cell
product will be invited to participate in this long term follow-up study. After
unblinding of the OTH/OZ1-INT-1 study, any patients in the placebo arm will be
withdrawn from this protocol
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