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
  Purpose

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

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 54
Detailed Description:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002395

Locations
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
Sponsors and Collaborators
SmithKline Beecham
  More Information

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 July 26, 2014