Search / Trial NCT00000665

Studies of the Ocular Complications of AIDS (SOCA) CMV Retinitis Trial: Foscarnet-Ganciclovir Component

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

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Trial Information

Current as of May 23, 2024

Completed

Keywords

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

Description

CMV retinitis is a common opportunistic infection in patients with AIDS. Ganciclovir is currently the only drug approved for treatment of CMV retinitis in immunocompromised patients. Ganciclovir suppresses CMV infections, and relapse occurs in virtually all AIDS patients when ganciclovir is discontinued. Because of their similar hematologic (blood) toxicities, the simultaneous use of ganciclovir and zidovudine (AZT) is not recommended. More recently the drug foscarnet has become available for investigational use. Studies so far indicate that remission of CMV retinitis occurs in 36 to 77 per...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Topical anti-Herpesvirus agents.
  • Zidovudine (AZT) for patients in deferral or foscarnet treatment groups:
  • 100 mg every 4 hours. For patients on ganciclovir:
  • 100 mg every 8 hours.
  • Dideoxyinosine (ddI) and other antiretroviral available via expanded access programs, investigational triazoles, granulocyte-macrophage colony-stimulating factor, and erythropoietin to treat marrow toxicity. The use of other investigational drugs will be considered on a drug by drug basis.
  • It is not recommended that patients receiving ganciclovir take AZT simultaneously. If AZT is prescribed for patients taking ganciclovir, it should be prescribed at reduced doses and discontinued if hematologic toxicity develops.
  • Patients must have:
  • Diagnosis of AIDS by CDC criteria or a documented HIV infection.
  • Cytomegalovirus (CMV) retinitis that does not require surgical intervention diagnosed in one or both eyes by a SOCA-certified ophthalmologist.
  • The means available for compliance with follow-up visits (including a caregiver if necessary).
  • Must consent to study or consent of parent or guardian if less than 18 years of age.
  • Willingness to take reduced dose of zidovudine (AZT) if dictated by treatment assignment.
  • Willingness to discontinue other systemic treatments for Herpesvirus infections while receiving foscarnet or ganciclovir.
  • Prior Medication:
  • Allowed:
  • Zidovudine (AZT).
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following conditions or symptoms are excluded:
  • Sufficient media opacities to preclude fundus photographs in both eyes.
  • Concurrent Medication:
  • Excluded:
  • Other systemic treatments for Herpesvirus infections.
  • Other anti-cytomegalovirus therapy.
  • Excluded with foscarnet:
  • Parenteral pentamidine, amphotericin B, or aminoglycosides.
  • Use of marrow toxic agents with ganciclovir and nephrotoxic agents with foscarnet is discouraged, and alternative treatment should be used whenever possible.
  • Patients with the following are excluded:
  • Sufficient media opacities to preclude fundus photographs in both eyes.
  • Known or suspected allergy to one of the study medications.
  • Prior Medication:
  • Excluded:
  • Foscarnet or ganciclovir used previously to treat cytomegalovirus (CMV) retinitis.
  • Excluded within 14 days of study entry:
  • CMV hyperimmunoglobulin or other anti-CMV agents.
  • Excluded within the past 28 days:
  • Anti-CMV therapy.
  • Active intravenous drug or alcohol abuse, sufficient in the investigator's opinion to prevent adequate compliance with study therapy and follow-up.

Attachments

readout_NCT00000665_2024-05-23.pdf

4.5 MB

NCT00000665_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

San Francisco, California, United States

New Orleans, Louisiana, United States

La Jolla, California, United States

Los Angeles, California, United States

Chicago, Illinois, United States

Baltimore, Maryland, United States

New York, New York, United States

New York, New York, United States

New York, New York, 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

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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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