Completed

Ganciclovir Therapy for Severe CMV Infection in Immunocompromised Patients

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What is being tested

Ganciclovir

Drug
Who is being recruted

Blood-Borne Infections+32

+ Urogenital Diseases

+ Genital Diseases

Over 3 Months
+14 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

This study focuses on providing a treatment called intravenous (IV) ganciclovir to patients with weakened immune systems who are battling serious or sight-threatening Cytomegalovirus (CMV) infection. The severity of their symptoms prevents them from participating in a controlled clinical study of ganciclovir therapy. The goal is to make this treatment accessible to those in critical need, aiming to improve their condition and address the challenges posed by this serious infection. During the study, patients receive an induction course of ganciclovir IV for 2 to 3 weeks, followed by a maintenance course of ganciclovir IV for an undefined duration. The study measures the safety and tolerance of this treatment regimen. It also keeps track of the patients' clinical responses to evaluate the effectiveness of ganciclovir in managing the CMV infection.

NCT00002025
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.

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 3 Months

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 DiseasesOpportunistic InfectionsRetinal DiseasesRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralEye InfectionsEye Infections, ViralLentivirus InfectionsMitochondrial DiseasesGenetic Diseases, InbornAcquired Immunodeficiency SyndromeCytomegalovirus InfectionsRetinitisHIV InfectionsAIDS-Related Opportunistic InfectionsCytomegalovirus RetinitisMultiple Acyl Coenzyme A Dehydrogenase Deficiency

Criteria

3 inclusion criteria required to participate
Patients must have a diagnosis of AIDS and life-threatening Cytomegalovirus (CMV) infection
Patients must have a diagnosis of other immunodeficiencies other than AIDS, with life-threatening or sight-threatening CMV disease
Patients must have been previously enrolled in compassionate use study (ICM 1257/1257A) or have terminated from another Syntex ganciclovir study
11 exclusion criteria prevent from participating
Children with congenital or neonatal CMV where there is not a documented primary or acquired immunodeficiency
Patients receiving alkylating agents
Patients receiving antimetabolite treatment that cannot be discontinued
Patients receiving cytokines
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 1 location

Roche Global Development - Palo Alto

Palo Alto, United StatesOpen Roche Global Development - Palo Alto in Google Maps
CompletedOne Study Center