Safety and Effectiveness of Topotecan HCl to Treat HIV-Infected Patients With AIDS-Related Progressive Multifocal Leukoencephalopathy (PML)
|ClinicalTrials.gov Identifier: NCT00002395|
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
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 or disease||Intervention/treatment||Phase|
|HIV Infections Leukoencephalopathy, Progressive Multifocal||Drug: Topotecan||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||54 participants|
|Masking:||None (Open Label)|
|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|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002395
|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|