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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01177059




Registration number
NCT01177059
Ethics application status
Date submitted
5/08/2010
Date registered
6/08/2010
Date last updated
12/12/2018

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 0 0
OZ1-HV1-202
Secondary ID [2] 0 0
CR016027
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV-1 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - OZ1 transduced cells

Other: Anti-HIV-1 Ribozyme (OZ1) transduced cells - OZ1 transduced cells Long term follow up of previously infused OZ1 transduced cells


Other interventions: OZ1 transduced cells
Long term follow up of previously infused OZ1 transduced cells
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Clonal Expansion of Cells With a Predominant OZ1 Insertion Site
Timepoint [1] 0 0
Approximately up to 15 years
Primary outcome [2] 0 0
Percentage of Participants With Insertional Oncogenesis
Timepoint [2] 0 0
Approximately up to 15 years
Primary outcome [3] 0 0
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
Timepoint [3] 0 0
Up to end of study (Approximately up to 15 years)

Eligibility
Key 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
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Other
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/12/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/11/2017
Sample size
Target
Accrual to date
Final
68
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Darlinghurst
Recruitment hospital [2] 0 0
- Surry Hills
Recruitment hospital [3] 0 0
- Sydney
Recruitment postcode(s) [1] 0 0
- Darlinghurst
Recruitment postcode(s) [2] 0 0
- Surry Hills
Recruitment postcode(s) [3] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
New York

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen-Cilag Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
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]) 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01177059
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen-Cilag Pty Ltd Clinical Trial
Address 0 0
Janssen-Cilag Pty Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries