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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

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
  Purpose

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.


Condition Intervention Phase
Cytomegalovirus Infections
HIV Infections
Drug: Sevirumab
Phase 1

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

Resource links provided by NLM:


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

  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).
  • 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.
  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: NCT00002268

Locations
United States, Alabama
Univ of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Texas
Univ TX Galveston Med Branch
Galveston, Texas, United States, 77550
Sponsors and Collaborators
Sandoz Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002268     History of Changes
Other Study ID Numbers: 071A, Study No B102
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
AIDS-Related Opportunistic Infections
Immunotherapy
Drug Evaluation
Cytomegalovirus Infections
Antibodies, Monoclonal

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Communicable Diseases
Cytomegalovirus Infections
HIV Infections
Immunologic Deficiency Syndromes
Infection
DNA Virus Infections
Herpesviridae Infections
Immune System Diseases
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 23, 2014