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

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

Clinical Details

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

Study design: Primary Purpose: Treatment

Eligibility

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

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.

Locations and Contacts

Davies Med Ctr, San Francisco, California 94114, United States
Additional Information

Related publications:

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)


Last updated: June 23, 2005

Page last updated: August 20, 2015

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