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Completed

Phase 3
Age: 13Years +
All Genders
ID00000136

Foscarnet-Ganciclovir CMV Retinitis Trial

Led by Johns Hopkins Bloomberg School of Public Health · Updated on 2015-10-22

234

Participants Needed

N/A

Research Sites

N/A

Total Duration

On this page

Sponsors

J

Johns Hopkins Bloomberg School of Public Health

Lead Sponsor

N

National Eye Institute (NEI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

To evaluate the relative safety and efficacy of ganciclovir and foscarnet as initial treatment of patients with cytomegalovirus (CMV) retinitis.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 13Years +
All Genders

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 Site Locations

Site Locations not provided

Location information for this trial is currently unavailable.

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