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

Completed · Phase 2

Conditions studied: HIV Infections, Leukoencephalopathy, Progressive Multifocal

In brief

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.

Key facts

Study ID

NCT00002395

Run by

SmithKline Beecham

People needed

54

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Veteran's Administration Hosp / West LA — Los Angeles, California, United States
• HIV Institute / Davies Med Ctr — San Francisco, California, United States
• Univ of Miami — Miami, Florida, United States
• Johns Hopkins Univ — Baltimore, Maryland, United States
• Albany Med College / Div of HIV Medicine — Albany, New York, United States

Full record on ClinicalTrials.gov

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