Search / Trial NCT00000766

CMV Retinitis Retreatment Trial

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

Trial Information

Current as of December 08, 2024

Completed

Keywords

Retinitis Ganciclovir Foscarnet Cytomegalovirus Infections Acquired Immunodeficiency Syndrome

ClinConnect Summary

Although therapy with foscarnet or ganciclovir halts retinitis progression in 90 percent of patients treated, relapses are common and may accelerate due to development of drug resistance, deteriorating immune function, or other factors. Treatment strategies currently being investigated include switching patients from one drug to the other or combining the two drugs.

Patients are randomized to receive foscarnet, ganciclovir, or a combination of the two drugs (administered sequentially). Initially, patients undergo single or multiple cycles of induction therapy for 14 days followed by mainte...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • Required:
  • At least 28 days of prior foscarnet or ganciclovir.
  • Concurrent Medication:
  • Allowed:
  • G-CSF.
  • Recommended:
  • Antiretroviral therapy.
  • Patients must have:
  • HIV infection or AIDS.
  • Active CMV retinitis after 28 or more days of either foscarnet or ganciclovir therapy.
  • At least one lesion with one-quarter disk area or more that can be photographed.
  • Visual acuity of 3 or more letters on ETDRS chart (5/200 Snellen) in an affected eye.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms and conditions are excluded:
  • Media opacity severe enough to preclude visualization of both fundi.
  • Retinal detachment not scheduled for surgical repair.
  • Patients with the following prior conditions are excluded:
  • History of intolerance to ganciclovir or foscarnet sufficient to contraindicate use.
  • History of combination foscarnet/ganciclovir therapy.
  • Active drug or alcohol abuse sufficient to prevent compliance.

About National Institute Of Allergy And Infectious Diseases (Niaid)

The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.

Locations

San Francisco, California, 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

Chapel Hill, North Carolina, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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