An Open Study of Foscarnet Treatment First Episode CMV-Retinitis in AIDS Patients
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
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: Treatment, Dose Comparison
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
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