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

This study has been completed.

Sponsored by: National Eye Institute (NEI)
Information provided by: National Eye Institute (NEI)
ClinicalTrials.gov Identifier: NCT00000136
  Purpose

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 III

MedlinePlus related topics:   AIDS    Cytomegalovirus Infections   

Drug Information available for:   Ganciclovir    Ganciclovir sodium    Foscarnet    Foscarnet sodium    Fosfonet sodium    Phosphonoacetic acid   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized

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

Study Start Date:   March 1990

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.

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

Criteria

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.

  Contacts and Locations

No Contacts or Locations Provided
  More Information


http://www.nei.nih.gov/NEWS/clinicalalerts/alert-soca-fgcrt.asp  This link exits the ClinicalTrials.gov site
 
Other Studies of the Ocular Complications of AIDS (SOCA)  This link exits the ClinicalTrials.gov site
 
http://www.nei.nih.gov/news/pressreleases/fgcrtpressrelease.asp  This link exits the ClinicalTrials.gov site
 

Publications:
[No authors listed] Studies of ocular complications of AIDS Foscarnet-Ganciclovir Cytomegalovirus Retinitis Trial: 1. Rationale, design, and methods. AIDS Clinical Trials Group (ACTG). Control Clin Trials. 1992 Feb;13(1):22-39.
 
[No authors listed] Assessment of cytomegalovirus retinitis. Clinical evaluation vs centralized grading of fundus photographs. Studies of Ocular Complications of AIDS Research Group, AIDS Clinical Trials Group. Arch Ophthalmol. 1996 Jul;114(7):791-805.
 
[No authors listed] Clinical vs photographic assessment of treatment of cytomegalovirus retinitis. Foscarnet-Ganciclovir Cytomegalovirus Retinitis Trial Report 8. Studies of Ocular Complications of AIDS Research Group, AIDS Clinical Trials Group. Arch Ophthalmol. 1996 Jul;114(7):848-55.
 
Wu AW, Coleson LC, Holbrook J, Jabs DA. Measuring visual function and quality of life in patients with cytomegalovirus retinitis. Development of a questionnaire. Studies of Ocular Complication of AIDS Research Group. Arch Ophthalmol. 1996 Jul;114(7):841-7.
 
[No authors listed] Cytomegalovirus (CMV) culture results, drug resistance, and clinical outcome in patients with AIDS and CMV retinitis treated with foscarnet or ganciclovir. Studies of Ocular Complications of AIDS (SOCA) in collaboration with the AIDS Clinical Trial Group. J Infect Dis. 1997 Jul;176(1):50-8.
 
[No authors listed] Foscarnet-Ganciclovir Cytomegalovirus Retinitis Trial: 5. Clinical features of cytomegalovirus retinitis at diagnosis. Studies of ocular complications of AIDS Research Group in collaboration with the AIDS Clinical Trials Group. Am J Ophthalmol. 1997 Aug;124(2):141-57.
 
[No authors listed] Rhegmatogenous retinal detachment in patients with cytomegalovirus retinitis: the Foscarnet-Ganciclovir Cytomegalovirus Retinitis Trial. The Studies of Ocular Complications of AIDS (SOCA) Research Group in Collaboration with the AIDS Clinical Trials Group (ACTG). Am J Ophthalmol. 1997 Jul;124(1):61-70.
 
[No authors listed] Mortality in patients with the acquired immunodeficiency syndrome treated with either foscarnet or ganciclovir for cytomegalovirus retinitis. Studies of Ocular Complications of AIDS Research Group, in collaboration with the AIDS Clinical Trials Group. N Engl J Med. 1992 Jan 23;326(4):213-20.
 
[No authors listed] Foscarnet-Ganciclovir Cytomegalovirus Retinitis Trial. 4. Visual outcomes. Studies of Ocular Complications of AIDS Research Group in collaboration with the AIDS Clinical Trials Group. Ophthalmology. 1994 Jul;101(7):1250-61.
 
[No authors listed] Antiviral effects of foscarnet and ganciclovir therapy on human immunodeficiency virus p24 antigen in patients with AIDS and cytomegalovirus retinitis. Studies of Ocular Complications of AIDS Research Group in collaboration with AIDS Clinical Trials Group. J Infect Dis. 1995 Sep;172(3):613-21.
 
[No authors listed] Morbidity and toxic effects associated with ganciclovir or foscarnet therapy in a randomized cytomegalovirus retinitis trial. Studies of ocular complications of AIDS Research Group, in collaboration with the AIDS Clinical Trials Group. Arch Intern Med. 1995 Jan 9;155(1):65-74.
 

Study ID Numbers:   NEI-35
First Received:   September 23, 1999
Last Updated:   June 2, 2006
ClinicalTrials.gov Identifier:   NCT00000136
Health Authority:   United States: Federal Government

Study placed in the following topic categories:
Phosphonoacetic Acid
Sexually Transmitted Diseases, Viral
Eye Diseases
Eye Infections
Acquired Immunodeficiency Syndrome
Cytomegalovirus Retinitis
Retinitis
Ganciclovir
Cytomegalovirus
Immunologic Deficiency Syndromes
Herpesviridae Infections
Cytomegalovirus retinitis
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Cytomegalovirus Infections
DNA Virus Infections
Foscarnet
Cytomegalic inclusion disease
Retroviridae Infections
Retinal Diseases

Additional relevant MeSH terms:
Anti-Infective Agents
RNA Virus Infections
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Eye Infections, Viral
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on October 29, 2008




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