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

Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cytomegalovirus Retinitis; HIV Infections

Intervention: Foscarnet sodium (Drug)

Phase: N/A

Status: Completed

Sponsored by: Astra USA

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).

Clinical Details

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

Study design: Primary Purpose: Treatment

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Foscarnet Research Program / Park Plaza Hosp, Houston, Texas 77004, United States
Additional Information

Related publications:

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)


Last updated: June 23, 2005

Page last updated: August 20, 2015

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