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

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00002039 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	An Open Study of Foscarnet Treatment First Episode CMV-Retinitis in AIDS Patients
Official Title ^ICMJE	An Open Study of Foscarnet Treatment First Episode CMV-Retinitis in AIDS Patients
Brief 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).
Detailed Description
Study Phase
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Dose Comparison
Condition ^ICMJE	Cytomegalovirus Retinitis HIV Infections
Intervention ^ICMJE	Drug: Foscarnet sodium
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00002039
Responsible Party
Study ID Numbers ^ICMJE	020A, 88-FOS-01
Study Sponsor ^ICMJE	Astra USA
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	March 1991
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP