Back to resultsSafety and Effectiveness of Topotecan HCl to Treat HIV-Infected Patients With AIDS-Related Progressive Multifocal Leukoencephalopathy (PML)
Primary Purpose
HIV Infections, Leukoencephalopathy, Progressive Multifocal
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Topotecan
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring AIDS-Related Opportunistic Infections, Leukoencephalopathy, Progressive Multifocal, Infusions, Intravenous, Drug Administration Schedule, Topotecan
Eligibility 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.
Sites / Locations
- Veteran's Administration Hosp / West LA
- HIV Institute / Davies Med Ctr
- Univ of Miami
- Johns Hopkins Univ
- Albany Med College / Div of HIV Medicine
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00002395
Brief Title
Safety and Effectiveness of Topotecan HCl to Treat HIV-Infected Patients With AIDS-Related Progressive Multifocal Leukoencephalopathy (PML)
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2000
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
SmithKline Beecham
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Leukoencephalopathy, Progressive Multifocal
Keywords
AIDS-Related Opportunistic Infections, Leukoencephalopathy, Progressive Multifocal, Infusions, Intravenous, Drug Administration Schedule, Topotecan
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
54 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Topotecan
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Veteran's Administration Hosp / West LA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
HIV Institute / Davies Med Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94114
Country
United States
Facility Name
Univ of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Johns Hopkins Univ
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Albany Med College / Div of HIV Medicine
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Effectiveness of Topotecan HCl to Treat HIV-Infected Patients With AIDS-Related Progressive Multifocal Leukoencephalopathy (PML)
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