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Sponsors and Collaborators: |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Tibotec Pharmaceutical Limited |
Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00074997 |
Phase II trial to determine safety and efficacy of an anti-HIV-1 gene transfer product.
Condition | Intervention | Phase |
HIV Infections |
Genetic: OZ1 (anti-HIV-1 gene) |
Phase II |
MedlinePlus related topics: | AIDS |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Phase II, Double-Blind, Controlled Trial to Evaluate the Safety and Efficacy of Autologous CD34+ Hematopoietic Progenitor Cells Transduced With Placebo or an Anti-HIV-1 Ribozyme (OZ1) in Patients With HIV-1 Infection |
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
Abnormal laboratory results at screening:
United States, California | |||||
University of California Los Angeles (UCLA) CARE Center | |||||
Los Angeles, California, United States, 90095-1793 | |||||
Stanford University, Department of Medicine, Division of Infectious Disease | |||||
Stanford, California, United States, 94305-5107 | |||||
AIDS Healthcare Foundation Research Centre | |||||
Los Angeles, California, United States, 90015 | |||||
Quest Clinical Research | |||||
San Francisco, California, United States, 94115 | |||||
Pacific Horizon Medical Group | |||||
San Francisco, California, United States, 94115 | |||||
United States, New York | |||||
Health Innovations Research | |||||
New York, New York, United States, 10011 | |||||
Australia, New South Wales | |||||
407 Doctors | |||||
Surry Hills, New South Wales, Australia, 2010 | |||||
Albion Street Centre | |||||
Surry Hills, New South Wales, Australia, 2010 | |||||
AIDS Research Initiative | |||||
Darlinghurst, New South Wales, Australia, 2010 | |||||
Holdsworth House General Practice | |||||
Darlinghurst, New South Wales, Australia, 2010 | |||||
Taylor Square Private Clinic | |||||
Darlinghurst, New South Wales, Australia, 2010 | |||||
St Vincent's Hospital; HIV, Immunology & Infectious Diseases Clinical Services Unit | |||||
Darlinghurst, New South Wales, Australia, 2010 |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Tibotec Pharmaceutical Limited |
Study Director: | Susan Pond | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Responsible Party: | Johnson & Johnson Research ( Susan Pond ) |
Study ID Numbers: | OTH/OZ1-INT-1, NIH/OBA Protocol 0107-486 |
First Received: | December 28, 2003 |
Last Updated: | January 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00074997 |
Health Authority: | United States: Food and Drug Administration; Australia: Department of Health and Ageing Therapeutic Goods Administration |
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