Completed

Comparative Evaluation of Oral and Intravenous Ganciclovir for Stable Cytomegalovirus Retinitis in AIDS Patients

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What is being tested

Ganciclovir

Drug
Who is being recruted

Blood-Borne Infections+30

+ Urogenital Diseases

+ Genital Diseases

Over 13 Years
+21 Eligibility Criteria
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

Two hundred twenty-five patients with AIDS and CMV retinitis are eligible for enrollment in Groups A, B, and C of the study, provided that each subject has received and tolerated a therapeutic course of intravenous (IV) ganciclovir of at least 4 weeks duration resulting in stable retinitis. An additional 100 subjects who have received and tolerated a course of IV or oral ganciclovir under any clinical trial of oral ganciclovir sponsored by Syntex Research and have stable retinitis may enter into Group D of this study and receive oral ganciclovir.

NCT00002247
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

225 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

7 inclusion criteria required to participate
Allowed: Zidovudine except during the first 2 weeks of any oral or IV ganciclovir maintenance therapy
Allowed: ddC
Allowed: ddI
CMV retinitis of no more than 4 months duration
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14 exclusion criteria prevent from participating
Dementia, decreased mentation, or other encephalopathic signs and symptoms that would interfere with the ability of the subject to give informed consent or comply with the protocol
Diagnosis of CMV retinitis more than 4 months prior to study entry
More than two induction treatment regimens with IV ganciclovir
More than two prior induction treatments of IV ganciclovir (initial induction and one re-induction are permitted)
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 20 locations

East Bay AIDS Ctr

Berkeley, United StatesOpen East Bay AIDS Ctr in Google Maps

AIDS Clinical Research Ctr / UCLA Med Ctr

Los Angeles, United States

UCSD Med Ctr / Pediatrics

San Diego, United States

San Francisco Gen Hosp

San Francisco, United States
Completed20 Study Centers