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

Sponsor:	Astra USA
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002039

Purpose

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).

Condition	Intervention
Cytomegalovirus Retinitis HIV Infections	Drug: Foscarnet sodium

Study Type:	Interventional
Study Design:	Treatment, Dose Comparison
Official Title:	An Open Study of Foscarnet Treatment First Episode CMV-Retinitis in AIDS Patients

Resource links provided by NLM:

MedlinePlus related topics: AIDS Cytomegalovirus Infections

Drug Information available for: Fosfonet sodium Foscarnet sodium Phosphonoacetic acid Foscarnet

U.S. FDA Resources

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002039

Locations

United States, Texas
Foscarnet Research Program / Park Plaza Hosp
Houston, Texas, United States, 77004

Sponsors and Collaborators

Astra USA

More Information

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)

Study ID Numbers:	020A, 88-FOS-01
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002039 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Retinitis
AIDS-Related Opportunistic Infections
Drug Therapy, Combination
Foscarnet

Cytomegalovirus Infections
Acquired Immunodeficiency Syndrome
Antiviral Agents
Zidovudine

Additional relevant MeSH terms:

Anti-Infective Agents
Communicable Diseases
Sexually Transmitted Diseases, Viral
Phosphonoacetic Acid
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Retinitis
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Cytomegalovirus Infections
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
Retinal Diseases

RNA Virus Infections
Immune System Diseases
Eye Infections, Viral
Eye Diseases
Cytomegalovirus Retinitis
Acquired Immunodeficiency Syndrome
Eye Infections
Enzyme Inhibitors
Antiviral Agents
Pharmacologic Actions
Immunologic Deficiency Syndromes
Herpesviridae Infections
Virus Diseases
HIV Infections
Sexually Transmitted Diseases

ClinicalTrials.gov processed this record on November 09, 2009