NCT00002251

Brief Summary

This study is designed to determine the influence of food on the absorption and relative bioavailability of oral ganciclovir by comparing the absorption of oral ganciclovir in a fed and fasting state at steady state plasma levels.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

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

May 1, 1991

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

Cytomegalovirus InfectionsHIV Infections

Keywords

AIDS-Related Opportunistic InfectionsGanciclovirCytomegalovirus InfectionsAcquired Immunodeficiency SyndromeBiological Availability

Interventions

GanciclovirDRUG

Eligibility Criteria

Age13 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients must have the following:
  • Confirmation of HIV infection by HIV antibody testing, p24 antigen, or culture of HIV.
  • Documented confirmation of present or past CMV infection.
  • Must understand the nature of the study, agree to tests required in the protocol, and must understand and sign an informed Consent form approved by the appropriate Institutional Review Board and by Syntex.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following conditions or symptoms are excluded:
  • Uncontrolled diarrhea or clinically significant gastrointestinal symptoms including persistent nausea or abdominal pain.
  • Concurrent Medication:
  • Excluded:
  • Antimetabolites. Interferons. Other nucleoside analogs. Zidovudine (AZT). Any investigational drug.
  • Patients with the following are excluded:
  • Karnofsky score \< 70.
  • Hypersensitivity to acyclovir.
  • Displaying signs of dementia or decreased mentation which would interfere with the ability of the subject to follow protocol schedule.
  • Prior Medication:
  • Excluded:
  • Anti-cytomegalovirus therapy including ganciclovir therapy for treatment of CMV disease.
  • Excluded within 4 days of study entry:
  • Antimetabolites.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Davies Med Ctr

San Francisco, California, 94114, United States

Location

Georgetown Univ Med Ctr

Washington D.C., District of Columbia, 20007, United States

Location

Related Publications (1)

  • Lavelle J, Follansbee S, Trapnell CB, Buhles WC, Griffy KG, Jung D, Dorr A, Connor J. Effect of food on the relative bioavailability of oral ganciclovir. J Clin Pharmacol. 1996 Mar;36(3):238-41. doi: 10.1002/j.1552-4604.1996.tb04193.x.

    PMID: 8690817BACKGROUND

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: 1991-05

Locations

US(2)