Completed

Safety and Tolerance of Anti-CMV Monoclonal Antibody in AIDS Patients with CMV Retinitis

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What is being tested

Sevirumab

Drug
Who is being recruted

Blood-Borne Infections+30

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
See protocol details

Summary

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

This study focuses on evaluating the safety and tolerance of a human anti-cytomegalovirus (CMV) monoclonal antibody, SDZ MSL-109, in patients diagnosed with Acquired Immunodeficiency Syndrome (AIDS) and CMV retinitis, an eye infection caused by the CMV virus. The trial aims to find the right dosage of SDZ MSL-109 that can be given alongside another medication, ganciclovir (DHPG), during the maintenance phase of the treatment. This research is important as it could potentially help improve the treatment options for AIDS patients suffering from CMV retinitis. During the trial, participants will receive one of three dosage levels of SDZ MSL-109 every two weeks for a total of 8 doses, while continuing their ganciclovir (DHPG) therapy. The study will monitor the safety and tolerance of these doses. For patients who have positive CMV cultures at the start of the trial, the study will also preliminarily assess the potential antiviral effects of using SDZ MSL-109 and ganciclovir (DHPG) together.

NCT00002016
Principal SponsorSandoz
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 18 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

Inclusion Criteria Concurrent Medication: Allowed: Zidovudine (AZT) < 600 mg/day. Experimental maintenance or prophylactic therapy with an approved therapeutic agent for a non-viral opportunistic infection. Trimethoprim / sulfamethoxazole (TMP / SMX). Pyrimethamine / sulfadoxine. Aerosolized pentamidine. Ketoconazole. Flucytosine (5-FC). Antituberculosis therapy. Concurrent Treatment: Allowed: Maintenance phase of ganciclovir (DHPG) therapy. Patients must have: AIDS with documented ophthalmologic findings consistent with cytomegalovirus (CMV) retinitis whose retinal lesions are less than 750 microns from the fovea and who have visual symptoms of CMV retinitis. Completed the treatment induction phase with ganciclovir (DHPG) and be about to participate in the maintenance phase DHPG therapy. Expected survival of = or > 6 months. Willingness and ability to give written informed consent. A copy of the signed and witnessed consent form must be maintained with the investigator's study files. Seropositive for the presence of circulating anti-CMV immunoglobulin. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Significant pulmonary dysfunction. Uncontrolled or unstable diabetes. Significant cardiovascular disease including uncontrolled hypertension, congestive heart failure, cardiac arrhythmia, angina pectoris, or a history of myocardial infarction within one year of entry into the study. Coagulation or hemorrhagic disorders. Any active severe opportunistic infection. Concurrent Medication: Excluded: Therapy with amphotericin B or fluconazole. Any other investigational drug. Biologicals including immunoglobulin therapy, granulocyte-macrophage-colony-stimulating-factor (GM-CSF), erythropoietin alpha, or any interleukin. Patients with the following are excluded: Any significant organ system dysfunction as described in Exclusion Co-existing Conditions. Any other severe concomitant clinical condition. Prior Medication: Excluded within 2 weeks of study entry: Therapy with amphotericin B or fluconazole. Any other investigational drug. Biologicals including immunoglobulin therapy, granulocyte-macrophage-colony-stimulating factor (GM-CSF), erythropoietin alpha, or any interleukin. Excluded: Prior treatment with monoclonal antibodies derived from any animal species. Prior Treatment: Excluded within 2 weeks of study entry: Major surgery.

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

Harvard (Massachusetts Gen Hosp)

Boston, United StatesOpen Harvard (Massachusetts Gen Hosp) in Google Maps

Univ TX Galveston Med Branch

Galveston, United States
Completed2 Study Centers