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Safety and Effectiveness of Topotecan HCl to Treat HIV-Infected Patients with AIDS-Related Progressive Multifocal Leukoencephalopathy (PML) Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Safety and Effectiveness of Topotecan HCl to Treat HIV-Infected Patients with AIDS-Related Progressive Multifocal Leukoencephalopathy (PML) conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Safety and Effectiveness of Topotecan HCl to Treat HIV-Infected Patients with AIDS-Related Progressive Multifocal Leukoencephalopathy (PML) Clinical research trials and Safety and Effectiveness of Topotecan HCl to Treat HIV-Infected Patients with AIDS-Related Progressive Multifocal Leukoencephalopathy (PML) healthcare trials take place in many of cities 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 evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Safety and Effectiveness of Topotecan HCl to Treat HIV-Infected Patients with AIDS-Related Progressive Multifocal Leukoencephalopathy (PML). Safety and Effectiveness of Topotecan HCl to Treat HIV-Infected Patients with AIDS-Related Progressive Multifocal Leukoencephalopathy (PML) Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Safety and Effectiveness of Topotecan HCl to Treat HIV-Infected Patients with AIDS-Related Progressive Multifocal Leukoencephalopathy (PML) clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Safety and Effectiveness of Topotecan HCl to Treat HIV-Infected Patients with AIDS-Related Progressive Multifocal Leukoencephalopathy (PML) condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Safety and Effectiveness of Topotecan HCl to Treat HIV-Infected Patients with AIDS-Related Progressive Multifocal Leukoencephalopathy (PML)  Safety and Effectiveness of Topotecan HCl to Treat HIV-Infected Patients with AIDS-Related Progressive Multifocal Leukoencephalopathy (PML)
Safety and Effectiveness of Topotecan HCl to Treat HIV-Infected Patients with AIDS-Related Progressive Multifocal Leukoencephalopathy (PML)
For Condition: HIV Infections,Leukoencephalopathy, Progressive Multifocal
Status: Completed
Sponsor(s): SmithKline Beecham ,
Synopsis: The purpose of this study is to see if it is safe and effective to give topotecan through a vein to treat HIV-infected patients with PML, an opportunistic (AIDS-related) infection caused by a virus that infects brain tissue and causes damage to the brain and the spinal cord. Topotecan fights HIV and the JC virus (the virus that causes PML) in laboratory experiments.
Details: Topotecan, a cytotoxic DNA topoisomerase-I inhibitor that crosses the blood-brain barrier, inhibits the replication of JC virus (the virus that causes PML) in vitro, at concentrations that are not toxic to human cells. Topotecan also inhibits the replication of HIV-1 and the function of Tat (which upregulates the replication of JC virus). Patients are randomized to be treated immediately with topotecan or to have treatment delayed for 8 weeks. The dosing schedule for patients receiving immediate or delayed treatment is topotecan as a continuous 21-day intravenous infusion every 28 days. All patients must have received optimal, stable antiretroviral therapy for 3 weeks prior to entry and preferably will continue that therapy during the study.
Eligibility:
Study Type: Interventional, Treatment, Open Label, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible for this study if they: - Are HIV-positive. - Have PML, including symptoms of PML. - Are able to complete the study. - Agree to have a catheter inserted in a vein. - Have taken at least 3 weeks of a stable anti-HIV drug combination (unless they are unable to take anti-HIV drugs). - Are at least 18 years old. - Agree to use effective methods of birth control. Exclusion Criteria Patients will not be eligible for this study if they: - Have a history of certain central nervous system (CNS) diseases. - Have a history of certain psychiatric disorders, such as bipolar disorder or schizophrenia. - Have syphilis that has not been treated. - Have certain severe medical problems, including AIDS-related opportunistic infections (such as PCP) that require treatment. - Have received chemotherapy in the past 30 days. - Have ever received chemotherapy for PML. - Are pregnant or breast-feeding. - Are taking certain medications, including any other investigational drugs.
Total Enrollment: 54
Location and Contact Information:
Univ of Miami
Miami, Florida, 33136
United States
Johns Hopkins Univ
Baltimore, Maryland, 21287
United States
Albany Med College / Div of HIV Medicine
Albany, New York, 12208
United States
Veteran's Administration Hosp / West LA
Los Angeles, California, 90073
United States
HIV Institute / Davies Med Ctr
San Francisco, California, 94114
United States
Additional Information:
Study ID Numbers: 284A; Protocol 111,SK&F 104864-A
Study Start Date:
Record last reviewed: July 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002395
Other Hiv Infections Studies:
1. Alternative Dosing Strategy for Anti-HIV Drugs
2. Safety and Effectiveness of Emtricitabine Taken Once Daily with Efavirenz and Didanosine in HIV-Infected Children Who Have Taken Few or No Anti-HIV Drugs
3. A Pilot Study of Immunization With HIV-1 Antigen Pulsed Allogenic Dendritic Cells in HIV-Infected Asymptomatic Patients With CD4+ T Cells > 350 cells/mm3
4. 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
5. Safety and Effectiveness of Lamivudine When Given Once a Day versus Twice a Day in Combination with Other Anti-HIV Drugs in HIV-Infected Adults Who Have Never Received Anti-HIV Drugs
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Safety and Effectiveness of Topotecan HCl to Treat HIV-Infected Patients with AIDS-Related Progressive Multifocal Leukoencephalopathy (PML)
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