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

• Adverse events, reportable events such as cancers and deaths [ 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. ] [ Designated as safety issue: Yes ]
  

• Clonal expansion of cells with a predominant OZ1 insertion site [ Time Frame: Lifelong follow-up ] [ Designated as safety issue: Yes ]
  
• Assess quantitative marking of the gene transfer product in peripheral blood mononuclear cells (PBMC) over time [ Time Frame: For a minimum of 15 years ] [ Designated as safety issue: Yes ]
  

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.