A Randomized, Phase I/II Trial to Assess the Safety and Antiviral Effects of Escalating Doses of A Human Anti-Cytomegalovirus Monoclonal Antibody (SDZ MSL-109) in Patients With the Acquired Immunodeficiency Syndrome and CMV Viremia and/or Viruria

Launched by SANDOZ · Aug 30, 2001

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

• • 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:
• • Major surgery.