San Francisco, California 94114

  • HIV Infections

Purpose:

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.


Criteria:

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.


Study is Available At:


Original ID:

020E


NCT ID:

NCT00002432


Secondary ID:

89-FOS-06


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

NIH AIDS Clinical Trials Information Service


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Primary Purpose: Treatment


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Study Dates

Verification Date:July 1990
Last Changed Date:June 23, 2005
First Received Date:November 2, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Foscarnet sodium

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Astra USA

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation: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)

Data Source: ClinicalTrials.gov

Date Processed: August 05, 2021

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