NCT00002432

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 foscarnet maintenance therapy for treatment of AIDS patients experiencing CMV retinitis.

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

July 1, 1990

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

Cytomegalovirus RetinitisHIV Infections

Keywords

RetinitisAIDS-Related Opportunistic InfectionsFoscarnetCytomegalovirus InfectionsAcquired Immunodeficiency Syndrome

Interventions

Foscarnet sodiumDRUG

Eligibility Criteria

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

You may qualify if:

  • Prior Medication:
  • Allowed:
  • Ganciclovir (DHPG).

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.
  • Concurrent Medication:
  • Excluded:
  • Nephrotoxic drugs.
  • Acyclovir.
  • 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.
  • Prior Medication:
  • Excluded within 7 days of study entry:
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Davies Med Ctr

San Francisco, California, 94114, United States

Location

Related Publications (1)

  • Leonard L, Lippe M, Follansbee S, Drennan D, Karol C. An open study of foscarnet treatment of cytomegalovirus (CMV) retinitis in AIDS patients. Int Conf AIDS. 1990 Jun 20-23;6(1):231 (abstract no ThB436)

    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: 1990-07

Locations

US(1)