Search / Trial NCT00000691

A Phase II Dose-Ranging, Open-Labelled Trial of Foscarnet Salvage Therapy for AIDS Patients With Sight-Threatening CMV Retinitis Who Cannot Be Treated With Ganciclovir Due To Myelosuppression or Treatment Failure

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

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Trial Information

Current as of May 26, 2024

Completed

Keywords

Retinitis Aids Related Opportunistic Infections Ganciclovir Drug Evaluation Foscarnet Cytomegalovirus Infections Acquired Immunodeficiency Syndrome Antiviral Agents

Description

Because of the seriousness of sight-threatening CMV retinitis in AIDS patients and a lack of other available treatments for those patients who cannot be treated with ganciclovir (DHPG) (because of its toxic effect on the body's blood-forming cells, because it did not control the disease, or because patient's blood cell or platelet counts are too low to begin with), it is worthwhile to try an immediate trial with foscarnet. AMENDED: ACTG 093 was originally designed as a randomized dose-ranging study of foscarnet maintenance therapy. Patients enrolled between March 17, 1989, and January 1, 19...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Aerosolized pentamidine for Pneumocystis carinii pneumonia (PCP) prophylaxis.
  • Oral antibiotics if patient is hematologically stable on that regimen for at least 30 days prior to study entry.
  • Therapy with vancomycin.
  • Drug therapy for Kaposi's sarcoma if patient is hematologically stable for at least 30 days prior to study entry.
  • Initiate or resume zidovudine (AZT) in 2nd week of foscarnet maintenance therapy at dose of 100 or 200 mg q4h at investigator's discretion.
  • Initiate or continue erythropoietin therapy via the treatment IND mechanism.
  • Initiate or continue therapy with investigational triazoles for disseminated fungal infections. Caution should be used in concurrent use of foscarnet and ciprofloxacin, as such use has appeared to exacerbate renal failure in one patient.
  • Prior Medication:
  • Allowed:
  • Oral antibiotics if patient is hematologically stable on that regimen for at least 30 days prior to study entry.
  • Drug therapy for Kaposi's sarcoma if patient is hematologically stable for at least 30 days prior to study entry.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following are excluded:
  • Corneal, lens, or vitreous opacification that precludes examination of the fundi.
  • Clinically significant pulmonary or neurologic impairment, including intubation or coma.
  • Karnofsky performance status = or < 50.
  • Concurrent Medication:
  • Excluded:
  • Immunomodulators.
  • Biologic response modifiers.
  • Investigational agents (other than erythropoietin and investigational triazoles).
  • Ganciclovir.
  • Didanosine (ddI).
  • Systemic acyclovir.
  • CMV hyperimmune serum / globulin.
  • Interferons.
  • Nephrotoxic agents including aminoglycosides, amphotericin B, parenteral pentamidine.
  • 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 with the following are excluded:
  • Corneal, lens, or vitreous opacification that precludes examination of the fundi.
  • Clinically significant pulmonary or neurologic impairment, including intubation or coma.
  • Unwilling or unable to suspend zidovudine treatment until 2nd week of foscarnet maintenance therapy.
  • Prior Medication:
  • Excluded:
  • Foscarnet for cytomegalovirus retinitis.
  • Systemic acyclovir.
  • Immunomodulators.
  • Biologic response modifiers.
  • Investigational agents (other than erythropoietin and investigational triazoles).
  • AIDS patients with active cytomegalovirus (CMV) retinitis who cannot be treated with ganciclovir. At least one pending CMV culture from both blood (buffy-coat) and urine must be obtained prior to study entry. Patients must be able to give informed consent. Patients with a history of a seizure disorder or central nervous system mass lesion will be included.

Attachments

readout_NCT00000691_2024-05-26.pdf

4.5 MB

NCT00000691_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

Los Angeles, California, United States

San Francisco, California, United States

Miami, Florida, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

Saint Louis, Missouri, United States

Buffalo, New York, United States

New York, New York, United States

New York, New York, United States

Rochester, New York, United States

Durham, North Carolina, United States

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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