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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002268
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: December 1991

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002268 on ClinicalTrials.gov Archive Site
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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
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

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.

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Interventional
Phase 1
Primary Purpose: Treatment
  • Cytomegalovirus Infections
  • HIV Infections
Drug: Sevirumab
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002268
071A, Study No B102
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Sandoz Inc.
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NIH AIDS Clinical Trials Information Service
December 1991

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP