NCT00002024

Brief Summary

To provide ganciclovir on a compassionate use basis to immunocompromised patients with serious cytomegalovirus (CMV) infections and to study safety and efficacy in this patient population.

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

September 1, 1989

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

Cytomegalovirus InfectionsHIV Infections

Keywords

AIDS-Related Opportunistic InfectionsImmune ToleranceGanciclovirDrugs, InvestigationalCytomegalovirus InfectionsAcquired Immunodeficiency Syndrome

Interventions

GanciclovirDRUG

Eligibility Criteria

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

You may qualify if:

  • Concurrent Medication:
  • Allowed:
  • Topical acyclovir.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following are excluded:
  • Mild to moderate cytomegalovirus (CMV) infections that fail to satisfy the clinical severity criteria.
  • Transplant where a trial reduction of immunosuppressive drug treatment is not feasible.
  • Congenital or neonatal CMV infections where there is not documented congenital or acquired immunodeficiency.
  • Neutropenia unless it is pre-existing.
  • Thrombocytopenia unless it is pre-existing.
  • Concurrent Medication:
  • Excluded:
  • Other myelosuppressive drugs such as cancer chemotherapy agents, interferon, foscarnet, or nucleoside analogs.
  • Patients with the following are excluded:
  • Mild to moderate cytomegalovirus (CMV) infections that fail to satisfy the clinical severity criteria.
  • Transplant where a trial reduction of immunosuppressive drug treatment is not feasible.
  • Congenital or neonatal CMV infections where there is not documented congenital or acquired immunodeficiency.
  • Neutropenia unless it is pre-existing.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Roche Global Development - Palo Alto

Palo Alto, California, 94303, United States

Location

Related Publications (1)

  • Spector SA, McKinley GF, Lalezari JP, Samo T, Andruczk R, Follansbee S, Sparti PD, Havlir DV, Simpson G, Buhles W, Wong R, Stempien M. Oral ganciclovir for the prevention of cytomegalovirus disease in persons with AIDS. Roche Cooperative Oral Ganciclovir Study Group. N Engl J Med. 1996 Jun 6;334(23):1491-7. doi: 10.1056/NEJM199606063342302.

    PMID: 8618603BACKGROUND

MeSH Terms

Conditions

Cytomegalovirus InfectionsHIV InfectionsAIDS-Related Opportunistic InfectionsMultiple Acyl Coenzyme A Dehydrogenase DeficiencyAcquired Immunodeficiency Syndrome

Interventions

Ganciclovir

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsBlood-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)

AcyclovirGuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic 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: 1989-09

Locations

US(1)