Safety and Effectiveness of Topotecan HCl to Treat HIV-Infected Patients With AIDS-Related Progressive Multifocal Leukoencephalopathy (PML)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00002395 |
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Recruitment Status :
Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Infections Leukoencephalopathy, Progressive Multifocal | Drug: Topotecan | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 54 participants |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | An Open, Comparative Phase II Study of Immediate Versus Delayed Treatment With Topotecan HCl Given as a Continuous 21-Day Infusion Every 28 Days to Patients With AIDS-Related Progressive Multifocal Leukoencephalopathy |
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002395
| United States, California | |
| Veteran's Administration Hosp / West LA | |
| Los Angeles, California, United States, 90073 | |
| HIV Institute / Davies Med Ctr | |
| San Francisco, California, United States, 94114 | |
| United States, Florida | |
| Univ of Miami | |
| Miami, Florida, United States, 33136 | |
| United States, Maryland | |
| Johns Hopkins Univ | |
| Baltimore, Maryland, United States, 21287 | |
| United States, New York | |
| Albany Med College / Div of HIV Medicine | |
| Albany, New York, United States, 12208 | |
| ClinicalTrials.gov Identifier: | NCT00002395 History of Changes |
| Other Study ID Numbers: |
284A Protocol 111 SK&F 104864-A |
| First Posted: | August 31, 2001 Key Record Dates |
| Last Update Posted: | June 24, 2005 |
| Last Verified: | July 2000 |
Keywords provided by NIH AIDS Clinical Trials Information Service:
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AIDS-Related Opportunistic Infections Leukoencephalopathy, Progressive Multifocal Infusions, Intravenous Drug Administration Schedule Topotecan |
Additional relevant MeSH terms:
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HIV Infections Leukoencephalopathies Leukoencephalopathy, Progressive Multifocal Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Encephalitis, Viral |
Central Nervous System Viral Diseases Polyomavirus Infections DNA Virus Infections Slow Virus Diseases Infectious Encephalitis Encephalitis Central Nervous System Infections Demyelinating Diseases Topotecan Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |