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A Study of Foscarnet in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002432
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: July 1990

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002432 on ClinicalTrials.gov Archive Site
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A Study of Foscarnet in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS
An Open Study of Foscarnet Treatment of 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 foscarnet maintenance therapy for treatment of AIDS patients experiencing CMV retinitis.

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Interventional
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Primary Purpose: Treatment
  • Cytomegalovirus Retinitis
  • HIV Infections
Drug: Foscarnet sodium
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Leonard L, Lippe M, Follansbee S, Drennan D, Karol C. An open study of foscarnet treatment of cytomegalovirus (CMV) retinitis in AIDS patients. Int Conf AIDS. 1990 Jun 20-23;6(1):231 (abstract no ThB436)

*   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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Inclusion Criteria

Prior Medication:

Allowed:

  • Ganciclovir (DHPG).

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.

Concurrent Medication:

Excluded:

  • Nephrotoxic drugs.
  • Acyclovir.

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.

Prior Medication:

Excluded within 7 days of study entry:

  • Immunomodulators.
  • Biologic response modifiers.
  • Investigational agents (other than ganciclovir).

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.
  • Patients who enter the study because of ganciclovir toxicity will have received ganciclovir therapy which resulted in either absolute neutrophil count falling to < 750 cells/mm3 or platelet count falling to < 50000 platelets/mm3 on two separate occasions during either:
  • A ganciclovir induction regimen of 7.5 mg (or more)/kg/day in divided doses.
  • A maintenance regimen of 5 mg (or more)/kg/day as a single daily dose.
  • Patients who enter the study because of ganciclovir treatment failure will meet one of the following criteria:
  • CMV retinitis progression has occurred either 1) at the end of a 10 - 21 day induction course of ganciclovir (7.5 - 10 mg/kg/day in divided doses) or 2) during the first 28 days of maintenance ganciclovir therapy (5 mg (or more)/kg/day, at least 5 days/week) where maintenance therapy began within 1 week of completing induction therapy.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002432
020E, 89-FOS-06
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Astra USA
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NIH AIDS Clinical Trials Information Service
July 1990

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