NCT00002039

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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

March 1, 1991

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

Cytomegalovirus RetinitisHIV Infections

Keywords

RetinitisAIDS-Related Opportunistic InfectionsDrug Therapy, CombinationFoscarnetCytomegalovirus InfectionsAcquired Immunodeficiency SyndromeAntiviral AgentsZidovudine

Interventions

Foscarnet sodiumDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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:
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foscarnet Research Program / Park Plaza Hosp

Houston, Texas, 77004, United States

Location

Related Publications (1)

  • 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)

    BACKGROUND

MeSH Terms

Conditions

Cytomegalovirus RetinitisHIV InfectionsRetinitisAIDS-Related Opportunistic InfectionsCytomegalovirus InfectionsAcquired Immunodeficiency Syndrome

Interventions

Foscarnet

Condition Hierarchy (Ancestors)

Eye Infections, ViralEye InfectionsInfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesEye DiseasesRetinal DiseasesBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesOpportunistic InfectionsSlow Virus Diseases

Intervention Hierarchy (Ancestors)

Phosphonoacetic AcidAcetatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsOrganophosphonatesOrganophosphorus Compounds

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1991-03

Locations

US(1)