Clinical Trials

MainTitle

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

This study has been completed
Sponsor
SmithKline Beecham


Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier
NCT00002395

First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: July 2000
History of Changes
Purpose

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: 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

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

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

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
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

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

More Information


Responsible Party: SmithKline Beecham  
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  

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
Leukoencephalopathies
Leukoencephalopathy, Progressive Multifocal
Topotecan

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.