A Phase I/II Trial to Assess the Safety and Tolerance of Escalating Doses of a Human Anti-Cytomegalovirus Monoclonal Antibody (SDZ MSL-109) in Patients With the Acquired Immunodeficiency Syndrome and CMV Retinitis

Launched by SANDOZ · Aug 30, 2001

Keywords

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Gender

ALL

Eligibility 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.