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

Phase 2

Completed

• Conditions: HIV Infections; Leukoencephalopathy, Progressive Multifocal

• Registration Number: NCT00002395
• Lead Sponsor: SmithKline Beecham

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.

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 Timeline

• Study First Submitted: 1999-11-02
• Status Verified: 2000-07
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (5)

Veteran's Administration Hosp / West LA; 🇺🇸 Los Angeles, California, United States

Johns Hopkins Univ; 🇺🇸 Baltimore, Maryland, United States

HIV Institute / Davies Med Ctr; 🇺🇸 San Francisco, California, United States

Univ of Miami; 🇺🇸 Miami, Florida, United States

Albany Med College / Div of HIV Medicine; 🇺🇸 Albany, New York, United States