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

Plain-language summary

This observational study provides long-term follow-up of people living with HIV-1 who received the gene therapy product anti-HIV-1 ribozyme (OZ1) in an earlier Phase 2 trial. Participants are seen twice a year until 5 years after the initial infusion and yearly thereafter. The aim is to record any ill effects of the gene therapy product and provide long-term safety information; only participants who received the final cell product in the base study (NCT00074997) were invited.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Completed

Sponsor

Janssen-Cilag Pty Ltd

Intervention

OZ1 transduced cells

Start date

12/6/2004

Estimated completion

11/30/2017

Countries

United States, Australia

Related genes

Locations

• Los Angeles, United States
• San Francisco, United States
• New York, United States
• Darlinghurst, Australia
• Surry Hills, Australia
• Sydney, Australia

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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 After unblinding of the OTH/OZ1-INT-1 study, any patients in the placebo arm will be withdrawn from this protocol