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
2 other identifiers
interventional
N/A
1 country
2
Brief Summary
To determine the safety, tolerance, and potential in vivo antiviral effects of five dosage levels and a dose to be determined of human anti-cytomegalovirus (CMV) monoclonal antibody (SDZ MSL-109; formerly SDZ 89-109) when administered once every 2 weeks for a total of 12 doses to patients with either AIDS or eligible AIDS-related complex (ARC) and with culture proven evidence of CMV viremia and/or viruria. Sandoglobulin will be employed as a comparative control.
Trial Health
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2 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
December 1, 1991
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- +7 more criteria
You may not qualify if:
- 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:
- Previous history of or evidence of idiopathic thrombocytopenia purpura, agammaglobulinemia, or hypogammaglobulinemia.
- Any other severe concomitant clinical condition.
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sandozlead
Study Sites (2)
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Univ TX Galveston Med Branch
Galveston, Texas, 77550, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1991-12