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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SmithKline Beecham
• Treatments: Topotecan

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.