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.
Condition | Intervention | Phase |
---|---|---|
HIV Infections Cytomegalovirus Retinitis |
Drug: Foscarnet Drug: Ganciclovir |
Phase 3 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Primary Purpose: Treatment |
Study Start Date: | March 1990 |
Study Completion Date: | October 1991 |
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.
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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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![](https://webarchive.library.unt.edu/web/20130312224802im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Additional Information:
Publications:
ClinicalTrials.gov 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:
HIV Infections Acquired Immunodeficiency Syndrome Retinitis Cytomegalovirus Retinitis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Retinal Diseases Eye Diseases |
Cytomegalovirus Infections Herpesviridae Infections DNA Virus Infections Eye Infections, Viral Eye Infections Foscarnet Phosphonoacetic Acid Ganciclovir Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on March 10, 2013