Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2025-12-29 @ 3:18 AM
Study NCT ID:
NCT00002250
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 Phase I Study of Recombinant Human CD4 Immunoglobulin G (rCD4-lgG) in Patients With HIV-Associated Immune Thrombocytopenic Purpura
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016553', 'term': 'Purpura, Thrombocytopenic, Idiopathic'}, {'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D011696', 'term': 'Purpura, Thrombocytopenic'}, {'id': 'D011693', 'term': 'Purpura'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D057049', 'term': 'Thrombotic Microangiopathies'}, {'id': 'D013921', 'term': 'Thrombocytopenia'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'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': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016860', 'term': 'CD4 Immunoadhesins'}], 'ancestors': [{'id': 'D015815', 'term': 'Cell Adhesion Molecules'}, {'id': 'D008562', 'term': 'Membrane Glycoproteins'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D007141', 'term': 'Immunoglobulin Fc Fragments'}, {'id': 'D007128', 'term': 'Immunoglobulin Fragments'}, {'id': 'D010446', 'term': 'Peptide Fragments'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D007127', 'term': 'Immunoglobulin Constant Regions'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D011993', 'term': 'Recombinant Fusion Proteins'}, {'id': 'D011994', 'term': 'Recombinant Proteins'}, {'id': 'D000954', 'term': 'Antigens, Surface'}, {'id': 'D000941', 'term': 'Antigens'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '1991-08', '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': ['Recombinant Proteins', 'IgG', 'Drug Evaluation', 'Antigens, CD4'], 'conditions': ['Immune Thrombocytopenic Purpura ( ITP )', 'HIV Infections']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Kahn J, Hassner A, Arri C, Coleman R, Kaplan L, Volberding P, Ammann A, Abrams D. A phase 1 study of recombinant human CD4 immunoglobulin g (rCD4-IgG) in patients with HIV-associated immune thrombocytopenic purpura. Int Conf AIDS. 1991 Jun 16-21;7(2):221 (abstract no WB2156)'}]}, 'descriptionModule': {'briefSummary': 'To test the effectiveness of recombinant human CD4 Immunoglobulin G (CD4-IgG) in the treatment of HIV-associated immune thrombocytopenic purpura in patients with all levels of HIV infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Dapsone at a constant dose level and only as a prophylaxis for Pneumocystis carinii pneumonia (PCP).\n* Zidovudine (AZT) at a constant dose for the 12 weeks of treatment, except if AZT-related toxicity is observed.\n\nPatients must have the following:\n\n* HIV seropositive (asymptomatic, AIDS-related complex, or AIDS).\n* HIV-associated immune thrombocytopenic purpura.\n* The ability to sign a written informed consent form, which must be obtained prior to treatment.\n* A willingness to abstain from all other experimental therapy for HIV infection during the entire study period.\n* Patients currently on zidovudine are not excluded. However, the zidovudine dose level must remain constant for 4 weeks prior to entry and for the 12 weeks of treatment, except if zidovudine related toxicity is observed.\n* A life expectancy of at least 3 months.\n\nPrior Medication:\n\nAllowed:\n\n* Dapsone at a constant dose for more than 2 weeks prior to study entry.\n* Zidovudine at a constant dose for 4 weeks prior to study entry.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following conditions and symptoms are excluded:\n\n* Active serious opportunistic infection (excluding positive block cultures of Mycobacterium avium complex or Cytomegalovirus).\n* Malignancies other than Kaposi's sarcoma.\n* Tumor-associated edema.\n* Visceral Kaposi's sarcoma.\n* Significant neurologic, cardiac, or liver disease.\n\nConcurrent Medication:\n\nExcluded:\n\n* Ganciclovir (DHPG). Pyrimethamine. Clindamycin. Sulfadiazine. Folinic acid. Prednisone. Intravenous gamma globulin. Intravenous acyclovir. Interferon. Systemic corticosteroids. Non-steroidal anti-inflammatory drugs (NSAIDs). Known immunomodulatory agents. Dideoxycytosine. Dideoxyinosine. Nucleoside analogs (with the exception of zidovudine or topical acyclovir). Any experimental therapy.\n\nPatients with the following are excluded:\n\n* Active serious opportunistic infection (excluding positive block cultures of Mycobacterium avium complex or Cytomegalovirus).\n* Malignancies other than Kaposi's sarcoma.\n* Kaposi's sarcoma requiring therapy.\n* Tumor-associated edema.\n* Visceral Kaposi's sarcoma.\n* Significant neurologic, cardiac, or liver disease.\n* Conditions requiring excluded concomitant medications.\n* Herpes virus infection requiring intravenous acyclovir.\n\nPrior Medication:\n\nExcluded for a minimum of 4 weeks prior to study entry:\n\n* Chemotherapy.\n* Immunomodulatory agents.\n* Any experimental therapy.\n\nPrior Treatment:\n\nExcluded for a minimum of 4 weeks prior to study entry:\n\n* Radiation therapy.\n* Any experimental therapy."}, 'identificationModule': {'nctId': 'NCT00002250', 'briefTitle': 'A Phase I Study of Recombinant Human CD4 Immunoglobulin G (rCD4-lgG) in Patients With HIV-Associated Immune Thrombocytopenic Purpura', 'organization': {'class': 'INDUSTRY', 'fullName': 'NIH AIDS Clinical Trials Information Service'}, 'officialTitle': 'A Phase I Study of Recombinant Human CD4 Immunoglobulin G (rCD4-lgG) in Patients With HIV-Associated Immune Thrombocytopenic Purpura', 'orgStudyIdInfo': {'id': '076A'}, 'secondaryIdInfos': [{'id': 'D0177g'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'CD4-IgG', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '941102859', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'San Francisco Gen Hosp', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}}}}