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Phase II trial of an anti-HIV-1 gene transfer product Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Phase II trial of an anti-HIV-1 gene transfer product conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Phase II trial of an anti-HIV-1 gene transfer product Clinical research trials and Phase II trial of an anti-HIV-1 gene transfer product healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Phase II trial of an anti-HIV-1 gene transfer product. Phase II trial of an anti-HIV-1 gene transfer product Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Phase II trial of an anti-HIV-1 gene transfer product clinical trial. Human subjects often receive the most effective healthcare possible for their Phase II trial of an anti-HIV-1 gene transfer product condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Phase II trial of an anti-HIV-1 gene transfer product  Phase II trial of an anti-HIV-1 gene transfer product
Phase II trial of an anti-HIV-1 gene transfer product
For Condition: HIV Infections
Status: Recruiting
Sponsor(s): Johnson & Johnson Research Pty Limited ,
Synopsis: Phase II trial to determine safety and efficacy of an anti-HIV-1 gene transfer product.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/45 Years
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: - HIV-1 infection for at least 6 months documented by positive HIV antibody and confirmed by Western Blot. - Aged between 18 – 45 years. - Receiving either the first or second regimen of ART (3 or more antiretroviral drugs in combination) for more than 6 months consecutively prior to study entry and maintaining suppression of viral load (less than 400 copies/ml) during the same period. Substitution of drugs in the same drug class due to toxicity is not considered a change in ART regimen. - Viral load less than 400 copies/ml, on two consecutive occasions, at least seven days apart. The second measurement must be within 14 days prior to G-CSF. - CD4+ cell count greater than 300 cells/mm3 measured on two consecutive occasions, at least 7 days apart. The second measurement must be within 14 days prior to G-CSF. - Women and men participating in this study (or their partners) must agree to use a medically accepted barrier form of contraception (i.e. male or female condoms or diaphragm). Women must have a negative serum pregnancy at screening and again within 7 days prior to G-CSF. EXCLUSION CRITERIA: - Any previous or current AIDS-defining illness by the CDC case definition, including AIDS-related dementia, with the exception of Kaposi’s sarcoma. - Abnormal laboratory results at screening: ** Hemoglobin < 8.5 g/dl for males and < 8 g/dl for females ** Platelet count < 75,000 cells/mm3 ** SGOT (AST) > 5 x upper limit of normal. ** Serum creatinine > 1.5 x upper limit of normal. ** Total bilirubin > 1.5 x upper limit of normal unless due to elevated indirect bilirubin obtained in a patient receiving indinavir and in the absence of any significant liver disease. - Patients with antecubital veins unsuitable for apheresis and unable to consent to the insertion of a catheter into an alternate vein (i.e. femoral, subclavian, jugular). - Patients taking ART combinations that include hydroxyurea or antiretroviral agents that exhibit antagonism when used together (e.g. zidovudine [AZT] and stavudine [d4T]). - Participation in any study involving an experimental drug or an experimental medical device in the 30 days prior to study entry, with the exception of FDA approved Phase III IND antiretroviral therapeutics. - Previous participation at any time in any study involving a gene transfer product. - Inability to provide informed consent. - Current pregnancy or lactation. - Any concurrent disease or reason that, in the opinion of the Investigator, would constitute a hazard for participating in the study. In particular, this includes any serious or chronic illnesses potentially affecting the risks of administration of G-CSF and of apheresis, such as bleeding or thromboembolic disorders, CD34+ cell engraftment, hematopoiesis and/or interpretation of results. - Continued alcohol consumption, drug abuse or other condition which, in the judgment of the Investigator, raises significant doubt about the patient's ability to comply with protocol requirements. - Known hypersensitivity to E. coli -derived recombinant proteins e.g. G-CSF.
Total Enrollment: 74
Location and Contact Information:
407 Doctors *Recruiting*
Surry Hills, New South Wales, 2010
Australia
Recruiting Robyn Vale +61 2 9332 2531
The Alfred Hospital *Recruiting*
Melbourne, Victoria, 3004
Australia
Recruiting Sally Algar +61 3 9276 6908
Holdsworth House General Practice *Recruiting*
Darlinghurst, New South Wales, 2010
Australia
Recruiting Samantha Miller +61 2 9331 7822
Taylor Square Private Clinic *Recruiting*
Darlinghurst, New South Wales, 2010
Australia
Recruiting Robyn Richardson +61 2 9331 6151
St Vincent’s Hospital; HIV, Immunology & Infectious Diseases Clinical Services Unit *Recruiting*
Darlinghurst, New South Wales, 2010
Australia
Recruiting Geraldine Dolan +61 2 8382 3214
Albion Street Centre *Recruiting*
Surry Hills, New South Wales, 2010
Australia
Recruiting Jega Sarangapany +61 2 9332 9656
AIDS Research Initiative *Recruiting*
Darlinghurst, New South Wales, 2010
Australia
Recruiting Jacinta Perram +61 2 9360 7172
Stanford University, Department of Medicine, Division of Infectious Disease *Recruiting*
Stanford, California, 94305-5107
United States
Recruiting Deborah Slamowitz 650-723-2804
University of California Los Angeles (UCLA) CARE Center *Recruiting*
Los Angeles, California, 90095-1793
United States
Recruiting Maria Palmer 310-206-6414
Additional Information:
Study ID Numbers: OTH/OZ1-INT-1; NIH/OBA Protocol 0107-486
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00074997
Other Hiv Infections Studies:
1. A Pilot Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Multicenter Trial to Evaluate the Effect of Ranitidine on Immunologic Indicators in Asymptomatic HIV-1 Infected Subjects With a CD4 Cell Count Between 400-700 Cells/mm3
2. ALVAC-HIV vCP1452 Alone and Combined with MN rgp120
3. Safety and Effectiveness of Adding PMPA Prodrug to an Anti-HIV Drug Combination to Treat HIV-Infected Patients
4. A Study of Saquinavir and Zalcitabine, Used Alone and Together, in the Treatment of Advanced HIV Infection in Patients Who Stopped Taking or Who Cannot Take Zidovudine
5. Adding New Drugs for HIV Infected Patients Failing Current Therapy
Related Studies:
Other HIV Infections Clinical Trials
Other New South Wales Clinical Trials
Other Darlinghurst Clinical Trials
Phase II trial of an anti-HIV-1 gene transfer product
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