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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002395
• Other study ID #: 284A
• Secondary ID: Protocol 111SK&F
• Status: Completed
• Phase: Phase 2
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: July 2000
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• Leukoencephalopathies
• Leukoencephalopathy, Progressive Multifocal

Intervention

Drug:
• Topotecan

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
SmithKline Beecham

Country where clinical trial is conducted

United States,