Completed

Oral vs. Intravenous Ganciclovir for Cytomegalovirus Retinitis Maintenance in AIDS Patients

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+30

+ Urogenital Diseases

+ Genital Diseases

Over 13 Years
+31 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
See protocol details

Summary

Principal SponsorRoche Global Development
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Patients who have received anti-CMV therapy with intravenous ganciclovir for at least 4 weeks that resulted in stable retinitis are randomized to receive one of three doses of oral ganciclovir or intravenous ganciclovir for 26 weeks of maintenance.

NCT00002330
Principal SponsorRoche Global Development
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

280 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.

Over 13 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 InfectionsEye DiseasesHerpesviridae InfectionsImmunologic Deficiency SyndromesImmune System DiseasesInfectionsMetabolic DiseasesMetabolism, Inborn ErrorsCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNutritional and Metabolic DiseasesRetinal DiseasesRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralEye InfectionsEye Infections, ViralLentivirus InfectionsMitochondrial DiseasesGenetic Diseases, InbornAcquired Immunodeficiency SyndromeCytomegalovirus InfectionsRetinitisHIV InfectionsCytomegalovirus RetinitisMultiple Acyl Coenzyme A Dehydrogenase Deficiency

Criteria

5 inclusion criteria required to participate
Allowed: Foscarnet prior to the 4 weeks of intravenous induction therapy.
No more than two episodes of CMV retinitis progression (relapse resulting in reinduction with intravenous anti-CMV therapy) since the original retinitis diagnosis.
Currently stable retinitis.
Allowed: Topical and ophthalmic nucleoside analogues.
Show More Criteria
26 exclusion criteria prevent from participating
Active CMV disease of the GI tract (e.g., CMV colitis, CMV esophagitis).
Isoprinosine.
More than three induction regimens with intravenous anti-CMV therapy.
Vidarabine.
Show More Criteria

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 36 locations

Univ of Alabama at Birmingham / AIDS Outpatient Clinic

Birmingham, United StatesOpen Univ of Alabama at Birmingham / AIDS Outpatient Clinic in Google Maps

McDowell Clinic

Phoenix, United States

Dr Ken Fisher

Phoenix, United States

Univ of Arizona / Health Science Ctr

Tucson, United States
Completed36 Study Centers