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

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.