An Open Study of Foscarnet Treatment First Episode CMV-Retinitis in AIDS Patients
Completed · Not applicable
Conditions studied: Cytomegalovirus Retinitis, HIV Infections
In brief
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).
Key facts
- Study ID
- NCT00002039
- Run by
- Astra USA
- Last updated by the study team
- 2005-06-24
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- 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.
Where it is running
- Foscarnet Research Program / Park Plaza Hosp — Houston, Texas, United States
Full record on ClinicalTrials.gov
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