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
Completed · Phase 2
Conditions studied: HIV-1
In brief
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.
Key facts
- Study ID
- NCT01177059
- Run by
- Janssen-Cilag Pty Ltd
- People needed
- 68
- Starts
- 2004-12-06
- Expected to finish
- 2017-11-30
- Last updated by the study team
- 2018-12-12
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 After unblinding of the OTH/OZ1-INT-1 study, any patients in the placebo arm will be withdrawn from this protocol
Where it is running
- Study site — Los Angeles, California, United States
- Study site — San Francisco, California, United States
- Study site — New York, New York, United States
- Study site — Darlinghurst, Australia
- Study site — Surry Hills, Australia
- Study site — Sydney, Australia
Full record on ClinicalTrials.gov
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