An Open Study of Foscarnet Treatment First Episode CMV-Re... | NCT00002039

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

NCT00002039

Sponsor

Astra USA

Status

Completed

Last Update Posted

Jun 24, 2005Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Cytomegalovirus Retinitis
HIV Infections

Interventions

Foscarnet sodium

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
88-FOS-01

Status Module

Record Verification Date

Mar 1991

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Nov 2, 1999

First Submission Date that Met QC Criteria

Aug 30, 2001

First Posted Date

Aug 31, 2001Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2005

Last Update Posted Date

Jun 24, 2005Estimated

Description Module

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Foscarnet sodium	Drug

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Foscarnet Research Program / Park Plaza Hosp		Houston	Texas	77004	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Background	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)

ID	Term
D017726	Cytomegalovirus Retinitis
D015658	HIV Infections
D012173	Retinitis
D017088	AIDS-Related Opportunistic Infections
D003586	Cytomegalovirus Infections
D000163	Acquired Immunodeficiency Syndrome

ID	Term
D015828	Eye Infections, Viral
D015817	Eye Infections
D007239	Infections
D006566	Herpesviridae Infections

ID	Term
D010746	Phosphonoacetic Acid
D000085	Acetates
D000144	Acids, Acyclic
D002264	Carboxylic Acids