Completed

Food Effect on Oral Ganciclovir Absorption

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Ganciclovir

Drug
Who is being recruted

Blood-Borne Infections+26

+ Urogenital Diseases

+ Genital Diseases

From 13 to 60 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
See protocol details

Summary

Principal SponsorHoffmann-La Roche
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

This study focuses on understanding how food affects the absorption of a medication called oral Ganciclovir. Ganciclovir is a drug used in the treatment of certain viral infections. The study aims to compare how well the body absorbs this drug when taken with food versus when taken without food, specifically looking at steady state plasma levels. This research is important as it can help determine the best way to take this medication for optimal effectiveness.

NCT00002251
Principal SponsorHoffmann-La Roche
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 13 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesAmino Acid Metabolism, Inborn ErrorsCommunicable DiseasesDNA Virus InfectionsHerpesviridae InfectionsImmunologic Deficiency SyndromesImmune System DiseasesInfectionsMetabolic DiseasesMetabolism, Inborn ErrorsCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNutritional and Metabolic DiseasesOpportunistic InfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsMitochondrial DiseasesGenetic Diseases, InbornAcquired Immunodeficiency SyndromeCytomegalovirus InfectionsHIV InfectionsAIDS-Related Opportunistic InfectionsMultiple Acyl Coenzyme A Dehydrogenase Deficiency

Criteria

Inclusion Criteria 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. Exclusion Criteria 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: Any concomitant conditions listed in Exclusion Co-Existing Conditions. 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. Interferons. Other nucleoside analogs. Zidovudine (AZT).

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Davies Med Ctr

San Francisco, United StatesOpen Davies Med Ctr in Google Maps

Georgetown Univ Med Ctr

Washington D.C., United States
Completed2 Study Centers