NCT00002301

Brief Summary

To evaluate the safety and efficacy of foscarnet induction treatment of cytomegalovirus (CMV) retinitis in AIDS patients who have previously suffered severe dose-limiting ganciclovir-related myelosuppression, who are ineligible for ganciclovir treatment due to myelosuppression or who have clearly failed to have a therapeutic response to ganciclovir therapy. To assess the duration of clinical response. To evaluate the effect on quantitative CMV cultures of blood and urine. To determine the effect on recovery of HIV p24 antigen capture direct from plasma.

Trial Health

55
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Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
unknown

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 InfectionsGanciclovirFoscarnetCytomegalovirus InfectionsAcquired Immunodeficiency SyndromeAntiviral Agents

Interventions

Foscarnet sodiumDRUG

Eligibility Criteria

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

You may qualify if:

  • Concurrent Medication:
  • Allowed:
  • Ganciclovir.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following are excluded:
  • Known allergy to foscarnet.
  • 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 in patients with cytomegalovirus (CMV) retinitis.
  • Concurrent Medication:
  • Excluded:
  • Acyclovir.
  • Nephrotoxic agent.
  • Patients with the following are excluded:
  • Known allergy to foscarnet.
  • 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 in patients with CMV retinitis.
  • Prior Medication:
  • Excluded within 7 days of study entry:
  • +15 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 InfectionsMultiple Acyl Coenzyme A Dehydrogenase DeficiencyCytomegalovirus 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 InfectionsAmino Acid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic DiseasesMitochondrial DiseasesSlow 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)