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

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Foscarnet sodium

About this trial

This is an interventional treatment trial for Cytomegalovirus Retinitis focused on measuring Retinitis, AIDS-Related Opportunistic Infections, Drug Therapy, Combination, Foscarnet, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome, Antiviral Agents, Zidovudine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Foscarnet Research Program / Park Plaza Hosp

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00002039

First Posted

November 2, 1999

Last Updated

June 23, 2005

Sponsor

Astra USA

1. Study Identification

Unique Protocol Identification Number

NCT00002039

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 1991

Overall Recruitment Status

Completed

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

Astra USA

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cytomegalovirus Retinitis, HIV Infections

Keywords

Retinitis, AIDS-Related Opportunistic Infections, Drug Therapy, Combination, Foscarnet, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome, Antiviral Agents, Zidovudine

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Foscarnet sodium

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

No

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.

Facility Information:

Facility Name

Foscarnet Research Program / Park Plaza Hosp

City

Houston

State/Province

Texas

ZIP/Postal Code

77004

Country

United States

12. IPD Sharing Statement

Citations:

Citation

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)

Results Reference

background

Cytomegalovirus Retinitis, HIV Infections

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial