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

This study has been completed.
Sponsor:
Information provided by:
National Eye Institute (NEI)
ClinicalTrials.gov Identifier:
NCT00000136
First received: September 23, 1999
Last updated: September 16, 2009
Last verified: September 2009

September 23, 1999
September 16, 2009
March 1990
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Complete list of historical versions of study NCT00000136 on ClinicalTrials.gov Archive Site
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Studies of the Ocular Complications of AIDS (SOCA)--Foscarnet-Ganciclovir CMV Retinitis Trial (FGCRT)
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To evaluate the relative safety and efficacy of ganciclovir and foscarnet as initial treatment of patients with cytomegalovirus (CMV) retinitis.

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.

Interventional
Phase 3
Allocation: Randomized
Primary Purpose: Treatment
  • HIV Infections
  • Cytomegalovirus Retinitis
  • Drug: Foscarnet
  • Drug: Ganciclovir
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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October 1991
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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.

Both
13 Years and older
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Contact information is only displayed when the study is recruiting subjects
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NCT00000136
NEI-35
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National Eye Institute (NEI)
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National Eye Institute (NEI)
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP