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

This study has been completed.
Information provided by:
National Eye Institute (NEI) Identifier:
First received: September 23, 1999
Last updated: September 16, 2009
Last verified: September 2009

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

Condition Intervention Phase
HIV Infections
Cytomegalovirus Retinitis
Drug: Foscarnet
Drug: Ganciclovir
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by National Eye Institute (NEI):

Study Start Date: March 1990
Study Completion Date: October 1991
Detailed 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: an initial 2-week course of high-dose therapy (induction) to control the infection followed by long-term lower dose therapy to prevent relapse (maintenance). The FGCRT compared foscarnet and ganciclovir as initial therapy for CMV retinitis.

The FGCRT was a multicenter, randomized, controlled clinical trial comparing foscarnet and ganciclovir as initial therapy for CMV retinitis. Patients with previously untreated CMV retinitis were randomized to therapy with either intravenous ganciclovir or intravenous foscarnet. The outcome measures of this trial were survival, retinitis progression, loss of visual function (visual acuity and visual field), and morbidity.


Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both

Males and females eligible for the FGCRT must have been 13 years or older and have had AIDS (CDC definition) or laboratory confirmation of HIV infection and CMV retinitis. They could not have received previous treatment with an anti-CMV drug for their CMV retinitis. Furthermore, they must have had an absolute neutrophil count (ANC) greater than or equal to 1,000 cells/mL and a serum creatinine less than or equal to 2.0 mg/dL in order to tolerate either drug.

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Additional Information:
Publications: Identifier: NCT00000136     History of Changes
Other Study ID Numbers: NEI-35
Study First Received: September 23, 1999
Last Updated: September 16, 2009
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cytomegalovirus Retinitis
Cytomegalovirus Infections
DNA Virus Infections
Eye Diseases
Eye Infections
Eye Infections, Viral
Herpesviridae Infections
Retinal Diseases
Virus Diseases
Phosphonoacetic Acid
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses processed this record on April 16, 2015