Safety and Effectiveness of Topotecan HCl to Treat HIV-Infected Patients With AIDS-Related Progressive Multifocal Leukoencephalopathy (PML)
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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 | Intervention | Phase |
---|---|---|
HIV Infections Leukoencephalopathy, Progressive Multifocal |
Drug: Topotecan |
Phase 2 |
Study Type: | Interventional |
Study Design: | Endpoint Classification: Safety Study Masking: 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 |
Estimated Enrollment: | 54 |
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.
![](https://webarchive.library.unt.edu/web/20130312000140im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
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.
![](https://webarchive.library.unt.edu/web/20130312000140im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
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 |
![](https://webarchive.library.unt.edu/web/20130312000140im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
No publications provided
ClinicalTrials.gov Identifier: | NCT00002395 History of Changes |
Other Study ID Numbers: | 284A, Protocol 111, SK&F 104864-A |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
AIDS-Related Opportunistic Infections Leukoencephalopathy, Progressive Multifocal Infusions, Intravenous Drug Administration Schedule Topotecan |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Leukoencephalopathy, Progressive Multifocal Leukoencephalopathies Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Encephalitis, Viral Encephalitis |
Central Nervous System Viral Diseases Polyomavirus Infections DNA Virus Infections Brain Diseases Central Nervous System Diseases Nervous System Diseases Central Nervous System Infections Demyelinating Diseases Topotecan Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents |
ClinicalTrials.gov processed this record on March 10, 2013