An Efficacy and Safety Study of Autologous Cluster of Differentiation 34 (CD34+) Hematopoietic Progenitor Cells Transduced With Placebo or an Anti- Human Immunodeficiency Virus Type 1 (HIV-1) Ribozyme (OZ1) in Participants With HIV-1 Infection
HIV-1
About this trial
This is an interventional treatment trial for HIV-1 focused on measuring Gene Therapy, Anti-HIV-1 Ribozyme, OZ1, HIV-1 Infections
Eligibility Criteria
Inclusion Criteria: An Human Immunodeficiency Virus 1 (HIV-1) infection for at least 6 months documented by positive HIV serology including confirmation by Western Blot Receiving either the first or second regimen of antiretroviral therapy (ART) defined as 3 or more antiretroviral drugs in combination A Viral load less than 400 copies per milliliter (copies/ml), as measured by Roche Amplicor HIV-1 Monitor assay, on 2 consecutive occasions, at least 7 days apart and within 45 days prior to granulocyte colony-stimulating factor (G-CSF) administration and the second measurement has to be within 14 days prior to G-CSF Cluster of Differentiation 4 (CD4+) cell count must be greater that 300 cells per cubic millimeter (cells/mm^3) Women and men (or their partners) had to agree to use a medically accepted form of contraception and safe sexual practices Exclusion Criteria: Any previous or current Acquired Immunodeficiency Syndrome (AIDS) defining illness by the Center for Disease Control (CDC) case definition, including AIDS-related dementia (mental decline), with the exception of Kaposi's sarcoma (purple or brown cancerous pimples on the skin, often associated with AIDS) Clinically significant clinical laboratory results Participants with veins unsuitable for study related procedures Current ART that included antiretroviral agents which exhibited antagonism when used together (example, zidovudine and stavudine ), or current or previous ART that included hydroxyurea Current pregnancy or breastfeeding
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
001
002
OZ1 Single intravenous infusion of 2-20 x 10 to the power of 7 OZ1 transduced autologous CD34+ cells per kilogram of body weight
Placebo Single intravenous infusion of placebo transduced autologous CD34+ cells per kilogram of body weight