drugset / Trial / NCT01177059

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

NCT01177059 ↗

Phase 2 Completed 68 enrolled Janssen-Cilag Pty Ltd
NaSingle-groupOpen-labelOther

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 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.

Timeline

Start
2004-12-06
Primary completion
2017-11-30
Completion
2017-11-30

Drugs

EvaluationDrugModalityDoseRoute
Subject OZ1 Oligonucleotide (other) — —

Indications

No indication recorded.