Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2025-12-27 @ 6:09 AM
Study NCT ID:
NCT00002268
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief 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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003586', 'term': 'Cytomegalovirus Infections'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D017088', 'term': 'AIDS-Related Opportunistic Infections'}], 'ancestors': [{'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009894', 'term': 'Opportunistic Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C409204', 'term': 'sevirumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '1991-12', 'lastUpdateSubmitDate': '2005-06-23', 'studyFirstSubmitDate': '1999-11-02', 'studyFirstSubmitQcDate': '2001-08-30', 'lastUpdatePostDateStruct': {'date': '2005-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2001-08-31', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['AIDS-Related Opportunistic Infections', 'Immunotherapy', 'Drug Evaluation', 'Cytomegalovirus Infections', 'Antibodies, Monoclonal'], 'conditions': ['Cytomegalovirus Infections', 'HIV Infections']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Zidovudine (AZT).\n* Acyclovir.\n* Experimental maintenance or prophylactic therapy with an approved therapeutic agent for a non-viral opportunistic infection.\n* Trimethoprim / sulfamethoxazole (TMP / SMX).\n* Pyrimethamine / sulfadoxine.\n* Inhaled pentamidine.\n* Amphotericin B.\n* Ketoconazole.\n* Flucytosine (5-FC).\n* Antituberculosis therapy.\n* Recombinant human erythropoietin.\n* Recombinant granulocyte-macrophage colony-stimulating factor (GM-CSF).\n* Recombinant human interferon alfa 2 for AIDS-related Kaposi's sarcoma.\n\nPatients must have:\n\n* 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.\n* Expected survival of = or \\> 6 months.\n* Willingness and ability to give written informed consent.\n* A copy of the signed and witnessed consent form must be maintained with the investigator's study files.\n* Positive culture results documenting the presence of cytomegalovirus (CMV) viremia and/or viruria.\n* Seropositive for the presence of circulating anti-CMV immunoglobulin.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following conditions or symptoms are excluded:\n\n* Significant pulmonary dysfunction.\n* Uncontrolled or unstable diabetes.\n* 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.\n* Coagulation or hemorrhagic disorders.\n* Any active severe opportunistic infection.\n\nConcurrent Medication:\n\nExcluded:\n\n* Therapy with ganciclovir (DHPG) or phosphonoformate (PFA) or other experimental anti-cytomegalovirus therapy except as stipulated in this protocol.\n* Any other experimental antiviral therapy.\n* Biologicals including immunoglobulin therapy (except those patients randomized to receive Sandoglobulin as specified in this protocol).\n\nPatients with the following are excluded:\n\n* Any significant organ system dysfunction as described in Exclusion co-existing conditions.\n* Previous history of or evidence of idiopathic thrombocytopenia purpura, agammaglobulinemia, or hypogammaglobulinemia.\n* Any other severe concomitant clinical condition.\n* 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.\n\nPrior Medication:\n\nExcluded within 2 weeks of study entry:\n\n* Therapy with ganciclovir (DHPG) or phosphonoformate (PFA) or other experimental anti-cytomegalovirus therapy except as stipulated in this protocol.\n* Any other experimental antiviral therapy.\n* Biologicals including immunoglobulin therapy (except those patients randomized to receive Sandoglobulin as specified in this protocol).\n* Excluded:\n* Prior treatment with monoclonal antibodies derived from any animal species.\n\nPrior Treatment:\n\nExcluded within 2 weeks of study entry:\n\n* Major surgery."}, 'identificationModule': {'nctId': 'NCT00002268', 'briefTitle': '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', 'organization': {'class': 'INDUSTRY', 'fullName': 'NIH AIDS Clinical Trials Information Service'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '071A'}, 'secondaryIdInfos': [{'id': 'Study No B102'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Sevirumab', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Univ of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '77550', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'Univ TX Galveston Med Branch', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sandoz', 'class': 'INDUSTRY'}}}}