AzTrials
AzTrials

HIV InfectionsPhase 2NCT00001048

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

A Phase 2 study testing Filgrastim, Cytarabine and Zidovudine in people with HIV Infections and Leukoencephalopathy, Progressive Multifocal, run by National Institute of Allergy and Infectious Diseases (NIAID) at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To compare the safety and efficacy of antiretroviral therapy (zidovudine plus either didanosine or dideoxycytidine) versus antiretroviral therapy plus intravenous cytarabine (Ara-C) versus antiretroviral therapy plus intrathecal Ara-C in the maintenance or improvement of neurological function over 6 months in… Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Filgrastim, Cytarabine and Zidovudine
How many people
90 participants
Where
9 sitesUnited States
Study dates
Start not givento Apr 1997
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • University of Colorado Hospital CRS

    Aurora, Colorado, 80262

  • Johns Hopkins Adult AIDS CRS

    Baltimore, Maryland, 21287

  • Massachusetts General Hospital ACTG CRS

    Boston, Massachusetts, 02114

  • Unc Aids Crs

    Chapel Hill, North Carolina, 275997215

  • Northwestern University CRS

    Chicago, Illinois, 60611

  • Univ. of Miami AIDS CRS

    Miami, Florida, 331361013

  • Univ. of Rochester ACTG CRS

    Rochester, New York, 14642

  • University of Washington AIDS CRS

    Seattle, Washington, 981224304

  • Washington U CRS

    St Louis, Missouri

Other trials in United States

About this study

Official 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

To compare the safety and efficacy of antiretroviral therapy (zidovudine plus either didanosine or dideoxycytidine) versus antiretroviral therapy plus intravenous cytarabine (Ara-C) versus antiretroviral therapy plus intrathecal Ara-C in the maintenance or improvement of neurological function over 6 months in HIV-infected individuals who have developed progressive multifocal leukoencephalopathy (PML). To compare the effect of these three treatment regimens on Karnofsky score and MRI studies.

The effectiveness of Ara-C in the treatment of PML, caused by a human DNA papovavirus (designated JC virus) infection, has not been determined, although the most encouraging results have occurred with intrathecal administration of the drug.

Read the detailed description

The effectiveness of Ara-C in the treatment of PML, caused by a human DNA papovavirus (designated JC virus) infection, has not been determined, although the most encouraging results have occurred with intrathecal administration of the drug.

Patients are randomized to receive antiretroviral therapy alone (AZT plus ddI or ddC), antiretroviral therapy plus intravenous Ara-C, or antiretroviral therapy plus intrathecal Ara-C. All patients receive 24 weeks of antiretroviral therapy. Beginning at week 2, patients on the intravenous Ara-C arm receive daily infusions of Ara-C over 5 days, with cycles repeating every 21 days. Patients on the intrathecal Ara-C arm receive single administrations of Ara-C at weeks 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, and 24. A brain biopsy confirmation or in situ hybridization will be required within 7 days after study entry. Patients are followed every 4 weeks.

Being tested
Filgrastim, Cytarabine, Zidovudine, Zalcitabine, Didanosine
Keywords
Leukoencephalopathy, Progressive Multifocal, Infusions, Intravenous, Cytarabine, Zalcitabine, Didanosine, Drug Therapy, Combination, Granulocyte Colony-Stimulating Factor, Acquired Immunodeficiency Syndrome, Zidovudine, Injections, Spinal
Medical subject headings
HIV Infections, Leukoencephalopathy, Progressive Multifocal, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2001 (estimated)
  2. Study completionApr 1997

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Enrolment
90 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00001048
Sponsor's protocol ID
ACTG 243
Other IDs
11220
Status last verified
Oct 2021
First submitted
2 Nov 1999
Last updated
1 Nov 2021
Results posted
No

Publications

  • Cytarabine nixed for PML. GMHC Treat Issues. 1996 Nov;10(11):9.

    PubMed 11364014

  • Post MJ, Yiannoutsos C, Simpson D, Booss J, Clifford DB, Cohen B, McArthur JC, Hall CD. Progressive multifocal leukoencephalopathy in AIDS: are there any MR findings useful to patient management and predictive of patient survival? AIDS Clinical Trials Group, 243 Team. AJNR Am J Neuroradiol. 1999 Nov-Dec;20(10):1896-906.

    PubMed 10588116

  • Hall C, Timpone J, Dafni I, Antonijevic Z, Millar L, Booss J, Clifford D, Cohen B, McArthur J, Hollander H. ARA-C treatment of PML in AIDS patients. Conf Retroviruses Opportunistic Infect.1997 Jan 22-26;4th:66 (abstract no 8)PMID: 97926517

  • Yiannoutsos CT, Major EO, Curfman B, Jensen PN, Gravell M, Hou J, Clifford DB, Hall CD. Relation of JC virus DNA in the cerebrospinal fluid to survival in acquired immunodeficiency syndrome patients with biopsy-proven progressive multifocal leukoencephalopathy. Ann Neurol. 1999 Jun;45(6):816-21. doi: 10.1002/1531-8249(199906)45:63.0.co;2-w.

    PubMed 10360779

  • Hall CD, Dafni U, Simpson D, Clifford D, Wetherill PE, Cohen B, McArthur J, Hollander H, Yainnoutsos C, Major E, Millar L, Timpone J. Failure of cytarabine in progressive multifocal leukoencephalopathy associated with human immunodeficiency virus infection. AIDS Clinical Trials Group 243 Team. N Engl J Med. 1998 May 7;338(19):1345-51. doi: 10.1056/NEJM199805073381903.

    PubMed 9571254

  • Crit Path AIDS Proj 1994-95 Winer; (No 30): 28-29. A phase II Multicenter Study Comparing Antiretroviral Therapy Alone to Antiretroviral Therapy Plku Cytosine Arabinosine (Cytarabine; Ara-C) for the Treatment of Progressive Multifocal Leukoencephalopathy (PML) in Human Immunodeficiency Virus (HIV)-Infected Subjects. .

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Filgrastim, Cytarabine and Zidovudine in people with HIV Infections and Leukoencephalopathy, Progressive Multifocal, run by National Institute of Allergy and Infectious Diseases (NIAID) at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00001048, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021.

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