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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


Phase 2
18 Years
45 Years
Open (Enrolling)
Both
HIV-1

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Trial Information

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


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 genes are inserted into an individual's cells and tissues to treat a
disease. The gene therapy OZ1 is thought to have anti-HIV-1 actions. This is an
Observational Study to provide long term follow-up of those HIV-1 infected patients who
received the gene therapy product (anti-HIV-1 Ribozyme [OZ1]) as part of the earlier study.
Patients are seen twice yearly until 5 years from initial infusion of study drug has elapsed
and then yearly for the rest of their lives. The study will monitor for and record any ill
effects from the gene therapy product to provide long term safety information. Observational
study - no investigational drug administered.


Inclusion Criteria:



- Patients must have received the Final Cell Product infusion in base study

- Have signed Informed Consent Form

Exclusion Criteria:

- Any patient from the base study that was assigned to the placebo arm

Type of Study:

Interventional

Study Design:

N/A

Outcome Measure:

Adverse events, reportable events such as cancers and deaths

Outcome Time Frame:

Lifetime of the patient. Each patient will have visits every 6 months until 5 years post infusion, then annual visits for safety assessments, until their death.

Safety Issue:

Yes

Principal Investigator

Janssen-Cilag Pty Ltd Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen-Cilag Pty Ltd

Authority:

United States: Food and Drug Administration

Study ID:

CR016027

NCT ID:

NCT01177059

Start Date:

December 2004

Completion Date:

December 2020

Related Keywords:

  • HIV-1
  • Gene Therapy
  • Anti-HIV-1 Ribozyme
  • OZ1
  • HIV-1 Infections
  • Acquired Immunodeficiency Syndrome
  • HIV Infections

Name

Location
Fountain Valley, California  92708
Albany, New York  12208