Completed

Long-Term Ganciclovir Therapy Safety for CMV Retinitis in AIDS Patients

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What is being tested

Zidovudine

+ Ganciclovir

Drug
Who is being recruted

Blood-Borne Infections+32

+ Urogenital Diseases

+ Genital Diseases

Over 13 Years
+20 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 the safety and tolerance of long-term therapy with a drug called Cytovene (Ganciclovir Sodium) for treating a specific eye condition, Cytomegalovirus (CMV) retinitis, in individuals diagnosed with AIDS. The goal is to understand how well this treatment works for newly diagnosed cases of this eye condition that threaten the macula, a crucial part of the eye. The study also aims to evaluate the safety and tolerance of this therapy when used alongside another drug, zidovudine (AZT), for an extended period. The importance of this study lies in its potential to improve treatment options for AIDS patients with CMV retinitis and enhance their overall care and survival.

NCT00002034
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

100 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 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

6 inclusion criteria required to participate
AIDS and newly diagnosed Cytomegalovirus (CMV) retinitis
An understanding of the nature of the study, agreement to its provisions, and willingness to sign the informed consent approved by the appropriate institutions review board, and Syntex
Other anti-retrovirals after consultation with the Syntex study monitor
Selected cytokines
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14 exclusion criteria prevent from participating
Concomitant conditions or diseases described in Exclusion Co-Existing Conditions
Dementia, decreased mentation or other encephalopathic signs and symptoms which would interfere with the ability of the patient to comply with the protocol
Demonstrated hypersensitivity to acyclovir or ganciclovir
Previous treatment with anti-cytomegalovirus therapy (e.g., ganciclovir, foscarnet or CMV hyperimmune globulin) within 1 month of study entry
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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 9 locations

Univ of Alabama at Birmingham

Birmingham, United StatesOpen Univ of Alabama at Birmingham in Google Maps

Summitt Med Ctr / San Francisco Gen Hosp

Oakland, United States

Stanford at Kaiser / Kaiser Permanente Med Ctr

San Francisco, United States

Miami Veterans Administration Med Ctr

Miami, United States
Completed9 Study Centers