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
Trial Information
Current as of January 15, 2025
Completed
Keywords
ClinConnect Summary
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
Trial Officials
Curtis Meinert, PhD
Principal Investigator
Johns Hopkins University
About Johns Hopkins Bloomberg School Of Public Health
The Johns Hopkins Bloomberg School of Public Health is a leading institution dedicated to advancing public health research and education. Renowned for its rigorous academic programs and commitment to improving global health outcomes, the School conducts innovative clinical trials that address pressing health challenges. With a focus on evidence-based practices, multidisciplinary collaboration, and community engagement, the Bloomberg School leverages its extensive resources and expertise to contribute to the development of effective public health interventions and policies. Through its research endeavors, the School aims to enhance population health and inform health policy both locally and globally.
Contacts
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
Discussion 0
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