Phase 3 Completed N=234 Randomized Single-blind Treatment

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

HIV · Cytomegalovirus retinitis

Source: ClinicalTrials.gov NCT00000136 ↗

Enrolled (actual)

234

Serious AEs

56.8%

Results posted

Oct 2015

Primary outcomePrimary: Mortality — 107; 127 participants

Summary

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Mortality	107; 127	—

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

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Data sourced from ClinicalTrials.gov (NCT00000136). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.