Comparison of Anti HIV Drugs Used Alone or in Combination With Cytosine Arabinoside to Treat Progressive Multifocal Leukoencephalopathy (PML) in HIV-Infected Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 8 November 2021
• Main ID: NCT00001048
• Date of registration: 02/11/1999
• Prospective Registration: No
• Primary sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Public title: Comparison of Anti HIV Drugs Used Alone or in Combination With Cytosine Arabinoside to Treat Progressive Multifocal Leukoencephalopathy (PML) in HIV-Infected Patients
• Scientific title: A Phase II Multicenter Study Comparing Antiretroviral Therapy Alone to Antiretroviral Therapy Plus Cytosine Arabinoside (Cytarabine; Ara-C) for the Treatment of Progressive Multifocal Leukoencephalopathy (PML) in Human Immunodeficiency Virus (HIV)-Infected Subjects
• Date of first enrolment: February 1998
• Target sample size: 90
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00001048
• Study type: Interventional
• Study design: Primary purpose: Treatment.
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Hall C

• Name: Timpone J

Key inclusion & exclusion criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

- Local intralesional chemotherapy for mucocutaneous Kaposi's sarcoma.

- Topical antifungals, clotrimazole, ketoconazole, fluconazole, and amphotericin B for
treatment of mucosal and esophageal candidiasis.

- Foscarnet for newly developed CMV infection, only after discussion with the protocol
chair.

- Prophylactic and maintenance therapy for other opportunistic infections, provided
patients are considered clinically stable.

- No more than 1000 mg/day acyclovir for herpes simplex.

- Antibiotics for bacterial infections as clinically indicated.

- Antipyretics, analgesics, and antiemetics.

Concurrent Treatment:

Allowed:

- Local radiation therapy for mucocutaneous Kaposi's sarcoma.

Patients must have:

- HIV infection.

- Confirmed PML.

- No other current active opportunistic infections requiring systemic therapy.

- Life expectancy of at least 3 months.

NOTE:

- A durable power of attorney is recommended where severe neurologic or psychiatric
impairment can be foreseen while the patient is on study.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

- Current active cryptococcal meningitis, cytomegaloviral encephalitis, toxoplasmosis
encephalitis, CNS lymphoma, or neurosyphilis.

NOTE:

- Patients on maintenance therapy for cryptococcal meningitis or toxoplasmosis
encephalitis that has been stable for 4 months are permitted.

- Conditions that seriously increase risk of a surgical procedure (e.g., coagulopathy,
severe thrombocytopenia).

- Any other disease that would interfere with evaluation of the patient.

- Other life-threatening complications likely to cause death in < 3 months.

Concurrent Medication:

Excluded:

- Ganciclovir.

- Interferon.

- Systemic chemotherapy other than Ara-C (unless specifically allowed).

- Antiretroviral medications other than AZT, ddI, or ddC.

Patients with the following prior conditions are excluded:

History of allergy or intolerance to G-CSF.

Prior Medication:

Excluded:

- Any prior Ara-C.

Excluded within 14 days prior to study:

- Ganciclovir or foscarnet.

- Interferon.

- Antiretroviral medications other than AZT, ddI, or ddC.

- Experimental medications for treatment of PML.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

HIV Infections

Leukoencephalopathy, Progressive Multifocal

Intervention(s)

Drug: Cytarabine

Drug: Zalcitabine

Drug: Didanosine

Drug: Filgrastim

Drug: Zidovudine

Secondary ID(s)

11220

ACTG 243

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Upjohn

Bristol-Myers Squibb