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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002432
• Other study ID #: 020E
• Secondary ID: 89-FOS-06
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: July 1990
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 foscarnet maintenance therapy for treatment of AIDS patients experiencing CMV retinitis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cytomegalovirus Retinitis
• HIV Infections
• Retinitis

Intervention

Drug:
• Foscarnet sodium

Locations

Country	Name	City	State
United States	Davies Med Ctr	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Astra USA

Country where clinical trial is conducted

United States, 

References & Publications (1)

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)