Studies of the Ocular Complications of AIDS (SOCA)--Foscarnet-Ganciclovir CMV Retinitis Trial (FGCRT) (FGCRT)
HIV Infections, Cytomegalovirus Retinitis
About this trial
This is an interventional treatment trial for HIV Infections
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Foscarnet
Ganciclovir
The induction dose for foscarnet is 60 mg/kg every 8 hours. Full dose maintenance therapy for foscarnet is 90 mg/kg/day
The induction dose for ganciclovir is 5 mg/kg every 12 hours. Full dose maintenance therapy for ganciclovir is 5 mg/kg every 24 hours, 7 days a week.