Safety and Effectiveness of Topotecan HCl to Treat HIV-Infected Patients With AIDS-Related Progressive Multifocal Leukoencephalopathy (PML)

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002395
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: July 2000

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002395 on ClinicalTrials.gov Archive Site
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Safety and Effectiveness of Topotecan HCl to Treat HIV-Infected Patients With AIDS-Related Progressive Multifocal Leukoencephalopathy (PML)
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

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Treatment
  • HIV Infections
  • Leukoencephalopathy, Progressive Multifocal
Drug: Topotecan
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002395
284A, Protocol 111, SK&F 104864-A
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SmithKline Beecham
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NIH AIDS Clinical Trials Information Service
July 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP