Search / Trial NCT00000136

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

Launched by JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH · Sep 23, 1999

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Trial Information

Current as of September 11, 2024

Completed

Keywords

Description

CMV retinitis is the most common intraocular infection in patients with AIDS and is estimated to affect 35 to 40 percent of patients with AIDS. Untreated CMV retinitis is a progressive disorder, the end result of which is total retinal destruction and blindness. The first two drugs approved by the United States Food and Drug Administration (FDA) for the treatment of CMV retinitis were ganciclovir (Cytovene) and foscarnet (Foscavir). At the time of this trial, both ganciclovir and foscarnet were available only as intravenous formulations. Both drugs were given in a similar two-step fashion: ...

Gender

ALL

Eligibility criteria

  • Inclusion criteria:
  • * CMV retinitis in one or both eyes
  • * At least 1/4 disk are of one CMV lesion photographable
  • * Diagnosis of AIDS as defined by Center for Disease Control criteria or documented HIV infection
  • * Age 13 and greater
  • * Visual acuity ≥ 3/200 in at least one eye diagnosed with CMV retinitis
  • * Absolute neutrophil count ≥ 1,000 cells/µl
  • * Platelet ≥ 25,000 cells/µl
  • * Serum creatinine ≥ 2.0 mg/dl
  • * Karnofsky score ≥ 60
  • * Informed consent
  • Exclusion criteria:
  • * Previous treatment of CMV retinitis
  • * Treatment with anti-CMV therapy for an extra-ocular CMV infection currently or in the past 28 days
  • * Known or suspected allergy to study drugs
  • * Pregnant or Lactating

About Sponsor

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

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