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.
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.
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)
