Inclusion Criteria
Concurrent Medication:
Allowed:
- Zidovudine (AZT).
- Acyclovir.
- Experimental maintenance or prophylactic therapy with an approved therapeutic agent for a non-viral opportunistic infection.
- Trimethoprim / sulfamethoxazole (TMP / SMX).
- Pyrimethamine / sulfadoxine.
- Inhaled pentamidine.
- Amphotericin B.
- Ketoconazole.
- Flucytosine (5-FC).
- Antituberculosis therapy.
- Recombinant human erythropoietin.
- Recombinant granulocyte-macrophage colony-stimulating factor (GM-CSF).
- Recombinant human interferon alfa 2 for AIDS-related Kaposi's sarcoma.
Patients must have:
- AIDS or be HIV positive with CD4 lymphocyte counts below 200 cells/mm3 and be receiving prophylaxis for Pneumocystis carinii pneumonia (PCP) (with or without prophylaxis for another opportunistic infection), but have no prior medical history of an opportunistic infection.
- 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.
- Positive culture results documenting the presence of cytomegalovirus (CMV) viremia and/or viruria.
- 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 ganciclovir (DHPG) or phosphonoformate (PFA) or other experimental anti-cytomegalovirus therapy except as stipulated in this protocol.
- Any other experimental antiviral therapy.
- Biologicals including immunoglobulin therapy (except those patients randomized to receive Sandoglobulin as specified in this protocol).
Patients with the following are excluded:
- Any significant organ system dysfunction as described in Exclusion co-existing conditions.
- Previous history of or evidence of idiopathic thrombocytopenia purpura, agammaglobulinemia, or hypogammaglobulinemia.
- Any other severe concomitant clinical condition.
- Documented, active cytomegalovirus (CMV) disease (tissue or organ invasion/dysfunction) at baseline. To this end, baseline indirect funduscopy (to detect and exclude patients with peripheral CMV retinitis) will be performed.
Prior Medication:
Excluded within 2 weeks of study entry:
- Therapy with ganciclovir (DHPG) or phosphonoformate (PFA) or other experimental anti-cytomegalovirus therapy except as stipulated in this protocol.
- Any other experimental antiviral therapy.
- Biologicals including immunoglobulin therapy (except those patients randomized to receive Sandoglobulin as specified in this protocol).
- Excluded:
- Prior treatment with monoclonal antibodies derived from any animal species.
Prior Treatment:
Excluded within 2 weeks of study entry: