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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002039
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: March 1991

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002039 on ClinicalTrials.gov Archive Site
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An Open Study of Foscarnet Treatment First Episode CMV-Retinitis in AIDS Patients
An Open Study of Foscarnet Treatment First Episode CMV-Retinitis in AIDS Patients

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).

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Interventional
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Primary Purpose: Treatment
  • Cytomegalovirus Retinitis
  • HIV Infections
Drug: Foscarnet sodium
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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)

*   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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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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002039
020A, 88-FOS-01
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Astra USA
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NIH AIDS Clinical Trials Information Service
March 1991

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