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An Open Study of Foscarnet Treatment First Episode CMV-Retinitis in AIDS Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00002039
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service

Study Description
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Brief Summary:
To evaluate the safety and efficacy of foscarnet induction therapy for treatment of AIDS patients experiencing their first episode of cytomegalovirus (CMV) retinitis. To evaluate the safety and efficacy of three different foscarnet maintenance therapy regimens. To determine the pharmacokinetics of intermittent administration of foscarnet with or without concomitant administration of zidovudine (AZT).

Condition or disease Intervention/treatment Phase
Cytomegalovirus Retinitis HIV Infections Drug: Foscarnet sodium Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: An Open Study of Foscarnet Treatment First Episode CMV-Retinitis in AIDS Patients

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

  • Any clinically significant pulmonary or neurologic impairment (e.g., patients who are intubated or comatose).
  • Corneal, lens, or vitreous opacification which precludes examination of the fundi, or evidence of tuberculotic, diabetic and/or hypertensive retinopathy.
  • Known allergy to foscarnet.
  • Recurrent episode of cytomegalovirus (CMV) retinitis.

Concurrent Medication:

Excluded:

  • Nephrotoxic drugs.

Patients with the following are excluded:

  • Recurrent episode of cytomegalovirus (CMV) retinitis.
  • Any clinically significant pulmonary or neurologic impairment (e.g., patients who are intubated or comatose).
  • Corneal, lens, or vitreous opacification which precludes examination of the fundi, or evidence of tuberculotic, diabetic, and/or hypertensive retinopathy.
  • Known allergy to foscarnet.

Prior Medication:

Excluded:

  • Ganciclovir for cytomegalovirus (CMV) retinitis.
  • Foscarnet for CMV retinitis.

Patients with AIDS as defined by the CDC with manifest first episode cytomegalovirus (CMV) retinitis, as identified by its characteristic ophthalmoscopic appearance and verified by fundus photography.

  • Patients must be able to give informed consent.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002039


Locations
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United States, Texas
Foscarnet Research Program / Park Plaza Hosp
Houston, Texas, United States, 77004
Sponsors and Collaborators
Astra USA
More Information
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Publications:
Ussery FM, Karol C, Conklin R, Gathe J, Stool E, Redding K. Preliminary results from an on-going prospective evaluation of foscarnet in the treatment of AIDS-associated cytomegalovirus retinitis. Int Conf AIDS. 1989 Jun 4-9;5:551 (abstract no MCP60)

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ClinicalTrials.gov Identifier: NCT00002039    
Other Study ID Numbers: 020A
88-FOS-01
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: March 1991
Keywords provided by NIH AIDS Clinical Trials Information Service:
Retinitis
AIDS-Related Opportunistic Infections
Drug Therapy, Combination
Foscarnet
 Cytomegalovirus Infections
Acquired Immunodeficiency Syndrome
Antiviral Agents
Zidovudine
Additional relevant MeSH terms:
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Infections
Cytomegalovirus Retinitis
Retinitis
Virus Diseases
Retinal Diseases
Eye Diseases
Eye Infections, Viral
Eye Infections
Cytomegalovirus Infections
Herpesviridae Infections
 DNA Virus Infections
Foscarnet
Phosphonoacetic Acid
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action