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MainTitle

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

This study has been completed
Sponsor
Sandoz


Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier
NCT00002016

First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: April 1993
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
Cytomegalovirus Retinitis
HIV Infections

Drug : Sevirumab
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: 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

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002016

Locations

United States, Massachusetts
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, United States, 02114
United States, Texas
Univ TX Galveston Med Branch
Galveston, Texas, United States, 77550

Sponsors and Collaborators

Sandoz
More Information

More Information


Responsible Party: Sandoz  
ClinicalTrials.gov Identifier: NCT00002016   History of Changes  
Other Study ID Numbers: 071B  
  Study No B103  
Study First Received: November 2, 1999  
Last Updated: June 23, 2005  

Keywords provided by NIH AIDS Clinical Trials Information Service:

Retinitis
Ganciclovir
Cytomegalovirus
Cytomegalovirus Infections
Acquired Immunodeficiency Syndrome
Antibodies, Monoclonal

Additional relevant MeSH terms:
HIV Infections
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
Retinitis
Cytomegalovirus Retinitis
Antibodies
Immunoglobulins
Antibodies, Monoclonal

ClinicalTrials.gov processed this data on October 20, 2017
This information is provided by ClinicalTrials.gov.