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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.

Sponsored by: Sandoz Pharmaceuticals
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002016
  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 I

MedlinePlus related topics:   AIDS    Cytomegalovirus Infections   

ChemIDplus related topics:   Ganciclovir    Ganciclovir sodium    Sevirumab   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Dose Comparison
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
  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

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 Pharmaceuticals
  More Information


Publications:
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)
 

Study ID Numbers:   071B, Study No B103
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002016
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Retinitis  
Ganciclovir  
Cytomegalovirus  
Cytomegalovirus Infections
Acquired Immunodeficiency Syndrome
Antibodies, Monoclonal

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
Eye Diseases
Eye Infections
Acquired Immunodeficiency Syndrome
Cytomegalovirus Retinitis
Retinitis
Ganciclovir
Cytomegalovirus
Immunologic Deficiency Syndromes
Herpesviridae Infections
Antibodies, Monoclonal
Cytomegalovirus retinitis
Virus Diseases
Antibodies
HIV Infections
Sexually Transmitted Diseases
Cytomegalovirus Infections
DNA Virus Infections
Cytomegalic inclusion disease
Retroviridae Infections
Retinal Diseases

Additional relevant MeSH terms:
RNA Virus Infections
Pathologic Processes
Disease
Slow Virus Diseases
Immunologic Factors
Eye Infections, Viral
Immune System Diseases
Syndrome
Physiological Effects of Drugs
Lentivirus Infections
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2008




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