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

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
HIV Infections; Leukoencephalopathy, Progressive Multifocal	Drug: Topotecan	Phase 2

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.

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Enrollment :	54 participants
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

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00002395 History of Changes
Other Study ID Numbers:	284A; Protocol 111; SK&F 104864-A
First Posted:	August 31, 2001
Last Update Posted:	June 24, 2005
Last Verified:	July 2000

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; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Encephalitis, Viral	Central Nervous System Viral Diseases; Polyomavirus Infections; DNA Virus Infections; Slow Virus Diseases; Infectious Encephalitis; Encephalitis; Central Nervous System Infections; Demyelinating Diseases; Topotecan; Topoisomerase I Inhibitors; Topoisomerase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents