Safety and Tolerance of Anti-CMV Monoclonal Antibody in AIDS Patients with CMV Retinitis
Sevirumab
Blood-Borne Infections+30
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
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 MapsUniv TX Galveston Med Branch
Galveston, United States