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
2 other identifiers
interventional
N/A
1 country
2
Brief Summary
To determine the safety and tolerance of 3 dosage levels of human anti-cytomegalovirus (CMV) monoclonal antibody (SDZ MSL-109) when administered once every 2 weeks for a total of 8 doses during the maintenance phase of ganciclovir (DHPG) therapy to patients with AIDS and documented evidence of CMV retinitis. In addition for those patients with positive CMV cultures upon entry into this trial a preliminary attempt will be made to assess the potential in vivo antiviral effects of the concomitant administration of DHPG and SDZ MSL-109.
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
April 1, 1993
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- +4 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 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 other severe concomitant clinical condition.
- Prior Medication:
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sandozlead
Study Sites (2)
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114, United States
Univ TX Galveston Med Branch
Galveston, Texas, 77550, United States
Related Publications (1)
Tolpin M, Pollard R, Tierney M, Nokta M, Wood D, Hirsch M. Combination therapy of cytomegalovirus (CMV) retinitis with a human monoclonal anti-CMV antibody (SDZ MSL 109) and either ganciclovir (DHPG) or foscarnet (PFA). Int Conf AIDS. 1993 Jun 6-11;9(1):54 (abstract no WS-B11-2)
BACKGROUND
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: 1993-04