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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002039
• Other study ID #: 020A
• Secondary ID: 88-FOS-01
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: March 1991
• 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 three different foscarnet maintenance therapy regimens. To determine the pharmacokinetics of intermittent administration of foscarnet with or without concomitant administration of zidovudine (AZT).

Recruitment information / eligibility

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

Eligibility

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.

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	Foscarnet Research Program / Park Plaza Hosp	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Astra USA

Country where clinical trial is conducted

United States, 

References & Publications (1)

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)