Status:
COMPLETED
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
Lead Sponsor:
Janssen-Cilag Pty Ltd
Conditions:
HIV-1
Eligibility:
All Genders
Phase:
PHASE2
Brief 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 \[OZ1\]) a...
Detailed 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 ge...
Eligibility Criteria
Inclusion
- 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
- 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 After unblinding of the OTH/OZ1-INT-1 study, any patients in the placebo arm will be withdrawn from this protocol
Key Trial Info
Start Date :
December 6 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2017
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT01177059
Start Date
December 6 2004
End Date
November 30 2017
Last Update
December 12 2018
Active Locations (6)
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1
Los Angeles, California, United States
2
San Francisco, California, United States
3
New York, New York, United States
4
Darlinghurst, Australia