Search / Trial NCT00000697

A Study of Foscarnet in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS Who Cannot Use Ganciclovir

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of March 02, 2024

Withdrawn

Keywords

Retinitis Aids Related Opportunistic Infections Bone Marrow Ganciclovir Foscarnet Cytomegalovirus Infections Acquired Immunodeficiency Syndrome Antiviral Agents

Description

CMV is a common virus, which can cause blindness and death in AIDS patients. Previous studies demonstrate that foscarnet has been effective in both AIDS and non-AIDS patients with CMV infection. Although treatment with ganciclovir (DHPG) is also effective, a significant toxicity leading to dose-limiting neutropenia (low white blood cell count) in one third of treated patients has been associated with the drug. Based on the serious nature of CMV retinitis and the lack of alternative drug therapies for DHPG-sensitive patients, the present study will evaluate the safety and efficacy of intrave...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed if hematologically stable on that regimen for at least 30 days prior to study entry:
  • Oral antibiotics.
  • Chemotherapy for Kaposi's sarcoma.
  • Acyclovir for outbreaks of herpes simplex or shingles.
  • Zidovudine (AZT), either initiated or continued, by patients randomized to both treatment arms. AZT given concurrently with foscarnet may be administered at a dose of 100 or 200 mg every 4 hours (q4h) at the investigator's discretion. Patients randomized to the delayed treatment arm may initiate or continue AZT administration at a dose of 100 or 200 mg q4h at the investigator's discretion. AZT may not be administered during the first 3 weeks of foscarnet therapy. Patients randomized to immediate therapy may begin or resume AZT when they enter the 2nd week of maintenance therapy (week 4 of the 10-week study period), if their hemoglobin is = or > 8 g/dl and absolute neutrophil count is = or > 1000 cells/mm3 at that time. Caution should be used in the concurrent use of foscarnet and ciprofloxacin, as such use has appeared to exacerbate renal failure in one patient.
  • Patients must have active AIDS-related cytomegalovirus (CMV) retinitis as identified by its characteristic ophthalmoscopic appearance and verified by fundus photography. Patients must also demonstrate one of the following clinical and/or laboratory findings:
  • Treatment with ganciclovir (DHPG) resulting in dose-limiting toxicity (absolute neutrophil count (= polymorphonuclear leukocytes plus bands) < 500 cells/mm3 or platelets < 25000 platelets/mm3) occurring on = or > two documented occasions at least 7 days apart while receiving up to a maximum induction regimen of 10 mg/kg/day or a maintenance regimen of up to 5 mg/kg/day. Neutropenia should not be the result of zidovudine (AZT) treatment.
  • Ineligibility for DHPG therapy because of baseline neutropenia (absolute neutrophil count < 500 cells/mm3) or thrombocytopenia (platelets < 25000 platelets/mm3) documented on = or > 2 occasions at least 7 days apart. Baseline myelosuppression should not be the result of ongoing therapy with either prescription drugs, including AZT, or over-the-counter medications.
  • Prior Medication:
  • Allowed:
  • Zidovudine (AZT), according to protocol stipulations.
  • Prophylaxis therapy for Pneumocystis carinii pneumonia (PCP).
  • Chemotherapy for Kaposi's sarcoma.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with any of the following diseases or symptoms are excluded:
  • An immediately sight-threatening lesion in a salvageable eye (i.e., patients who have a cytomegalovirus (CMV) lesion that is within 1500 microns of the optic disc or fovea in an eye with correction vision of 20/100 or better).
  • Corneal, lens or vitreous opacification which precludes examination of the fundi of either eye.
  • Any clinically significant pulmonary or neurologic impairment (i.e., patients who are intubated or comatose), although patients with a history of a seizure disorder or a central nervous system (CNS) mass lesion may be enrolled.
  • Concurrent Medication:
  • Excluded:
  • Systemic acyclovir as preventive therapy for herpes infection.
  • Any nephrotoxic agent.
  • Specifically excluded are aminoglycosides, amphotericin B, and parenteral pentamidine. A patient who requires such therapy must be temporarily discontinued from study therapy; if nephrotoxic therapy is given for > 7 days, the patient will be permanently withdrawn from study therapy.
  • Other anti-cytomegalovirus (CMV) therapy, specifically ganciclovir, CMV hyperimmune serum/globulin, interferons, and immunomodulators.
  • Patients will be excluded from the study if they are unwilling or unable to suspend zidovudine (AZT) treatment during the first 3 weeks of the study period (1) if randomized to the immediate treatment arm, or (2) when crossed-over from the delayed treatment arm to foscarnet therapy because of retinitis progression.
  • Prior Medication:
  • Excluded:
  • Foscarnet for cytomegalovirus (CMV) retinitis.
  • Excluded within 7 days of study entry:
  • Immunomodulators.
  • Investigational agents other than ganciclovir.

Attachments

readout_NCT00000697_2024-03-02.pdf

4.5 MB

NCT00000697_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

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Michael Foster
20 September 2023

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Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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