Food Effect on Oral Ganciclovir Absorption
Ganciclovir
Blood-Borne Infections+26
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.20 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
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
Georgetown Univ Med Ctr
Washington D.C., United States