Completed

Topotecan HCl for AIDS-Related Progressive Multifocal Leukoencephalopathy

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What is being tested

Topotecan

Drug
Who is being recruted

Infectious Encephalitis+28

+ Blood-Borne Infections

+ Neuroinflammatory Diseases

Over 18 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
See protocol details

Summary

Principal SponsorSmithKline Beecham
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

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.

NCT00002395
Principal SponsorSmithKline Beecham
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

54 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Infectious EncephalitisBlood-Borne InfectionsNeuroinflammatory DiseasesUrogenital DiseasesGenital DiseasesBrain DiseasesCentral Nervous System DiseasesCentral Nervous System InfectionsCommunicable DiseasesDemyelinating DiseasesDNA Virus InfectionsEncephalitisImmunologic Deficiency SyndromesImmune System DiseasesInfectionsNervous System DiseasesOpportunistic InfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsEncephalitis, ViralCentral Nervous System Viral DiseasesPolyomavirus InfectionsLeukoencephalopathiesLeukoencephalopathy, Progressive MultifocalHIV InfectionsAIDS-Related Opportunistic Infections

Criteria

7 inclusion criteria required to participate
Agree to have a catheter inserted in a vein
Agree to use effective methods of birth control
Are HIV-positive
Are able to complete the study
Show More Criteria
8 exclusion criteria prevent from participating
Are pregnant or breast-feeding
Are taking certain medications, including any other investigational drugs
Have a history of certain central nervous system (CNS) diseases
Have a history of certain psychiatric disorders, such as bipolar disorder or schizophrenia
Show More Criteria

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 5 locations

Veteran's Administration Hosp / West LA

Los Angeles, United StatesOpen Veteran's Administration Hosp / West LA in Google Maps

HIV Institute / Davies Med Ctr

San Francisco, United States

Univ of Miami

Miami, United States

Johns Hopkins Univ

Baltimore, United States
Completed5 Study Centers