Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2025-12-31 @ 12:42 PM
Study NCT ID:
NCT00002359
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multicenter, Double-Blind, Phase III, Adjuvant-Controlled Study of the Effect of 10 Units of HIV-1 Immunogen (Remune) Compared to Incomplete Freund's Adjuvant (IFA) Alone Every 12 Weeks on AIDS-Free Survival in Subjects With HIV Infection and CD4 T-Lymphocytes Between 300 and 549 Cells/microL Rega
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000386', 'term': 'AIDS-Related Complex'}], 'ancestors': [{'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'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C098825', 'term': "HIV-1 immunogen, incomplete Freund's adjuvant"}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 3000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '1997-06', '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': ['Vaccines, Synthetic', 'Viral Vaccines', 'HIV-1', 'AIDS-Related Complex', 'AIDS Vaccines', 'Salk HIV Immunogen'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '11056590', 'type': 'BACKGROUND', 'citation': 'Kahn JO, Cherng DW, Mayer K, Murray H, Lagakos S. Evaluation of HIV-1 immunogen, an immunologic modifier, administered to patients infected with HIV having 300 to 549 x 10(6)/L CD4 cell counts: A randomized controlled trial. JAMA. 2000 Nov 1;284(17):2193-202. doi: 10.1001/jama.284.17.2193.'}, {'pmid': '28154006', 'type': 'DERIVED', 'citation': 'Rao MP, Al-Khatib SM, Pokorney SD, She L, Romanov A, Nicolau JC, Lee KL, Carson P, Selzman CH, Stepinska J, Cleland JG, Tungsubutra W, Desvigne-Nickens PM, Sueta CA, Siepe M, Lang I, Feldman AM, Yii M, Rouleau JL, Velazquez EJ; STICH Trial Investigators. Sudden Cardiac Death in Patients With Ischemic Heart Failure Undergoing Coronary Artery Bypass Grafting: Results From the STICH Randomized Clinical Trial (Surgical Treatment for Ischemic Heart Failure). Circulation. 2017 Mar 21;135(12):1136-1144. doi: 10.1161/CIRCULATIONAHA.116.026075. Epub 2017 Feb 2.'}]}, 'descriptionModule': {'briefSummary': 'To determine the effect of HIV-1 immunogen (Remune) on AIDS-free survival, defined as the time prior to development of an AIDS-defining condition or death.', 'detailedDescription': 'Patients receive 10 units of HIV-1 immunogen in IFA or IFA alone every 12 weeks, then are followed for 104-148 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Antiretrovirals if on a stable dose for at least the past 3 months.\n\nPatients must have:\n\n* HIV-1 infection with CD4 count 300-549 cells/mm3.\n* No AIDS-defining condition.\n* Been on a stable dose of antiretroviral for the past 3 months, if taking antiretrovirals.\n\nNOTE:\n\n* KS is permitted if not requiring systemic therapy.\n\nPrior Medication:\n\nAllowed:\n\n* Prior antiretrovirals.\n\nExclusion Criteria\n\nConcurrent Medication:\n\nExcluded:\n\n* Systemic chemotherapy for KS.\n* Treatment for malignancy other than basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.\n\nPatients with the following prior conditions are excluded:\n\n* History of any illness that would interfere with study.\n* Acute infection requiring prescription therapy within the past month, other than genital herpes and oral or vaginal candidiasis.\n\nPrior Medication:\n\nExcluded:\n\n* Prior HIV-1 Immunogen. Unwilling to use effective safe sex practices. Active substance abuse.'}, 'identificationModule': {'nctId': 'NCT00002359', 'briefTitle': "A Multicenter, Double-Blind, Phase III, Adjuvant-Controlled Study of the Effect of 10 Units of HIV-1 Immunogen (Remune) Compared to Incomplete Freund's Adjuvant (IFA) Alone Every 12 Weeks on AIDS-Free Survival in Subjects With HIV Infection and CD4 T-Lymphocytes Between 300 and 549 Cells/microL Rega", 'organization': {'class': 'INDUSTRY', 'fullName': 'NIH AIDS Clinical Trials Information Service'}, 'officialTitle': "A Multicenter, Double-Blind, Phase III, Adjuvant-Controlled Study of the Effect of 10 Units of HIV-1 Immunogen (Remune) Compared to Incomplete Freund's Adjuvant (IFA) Alone Every 12 Weeks on AIDS-Free Survival in Subjects With HIV Infection and CD4 T-Lymphocytes Between 300 and 549 Cells/microL Regardless of Concomitant HIV Therapies", 'orgStudyIdInfo': {'id': '092'}, 'secondaryIdInfos': [{'id': '806'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'HIV-1 Immunogen', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Phoenix Body Positive', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92718', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'Ctr for Special Immunology', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '90028', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Jeffrey Goodman Special Care Clinic', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90036', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Kraus Med Partners', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars Sinai Med Ctr', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94063', 'city': 'Redwood City', 'state': 'California', 'country': 'United States', 'facility': 'AIDS Community Research Consortium', 'geoPoint': {'lat': 37.48522, 'lon': -122.23635}}, {'zip': '20009', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Whitman Walker Clinic Inc', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '20037', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Anderson Clinical Research', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '20037', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'George Washington Univ Med Ctr', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33316', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'North Broward Hosp District', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33140', 'city': 'Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Ctr for Special Immunology', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'zip': '33179', 'city': 'North Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'The Coleman Institute', 'geoPoint': {'lat': 25.89009, 'lon': -80.18671}}, {'zip': '33617', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Pharmacology Services', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'AIDS Research Consortium of Atlanta', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush Med Ctr', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60657', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Chicago AIDS Research Alliance', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60657', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Ctr for Special Immunology', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46219', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Community Hosp Indianapolis', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '67214', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'UKSM-W Med Practice Association', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Univ of Kentucky / Division of ID Research', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '02210', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'JSI Research and Training Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02445', 'city': 'Brookline Village', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Community Research Initiative of New England', 'geoPoint': {'lat': 42.33288, 'lon': -71.11616}}, {'zip': '01040', 'city': 'Holyoke', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Providence Mercy Hosp', 'geoPoint': {'lat': 42.20426, 'lon': -72.6162}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Wayne State Univ / WSU / DMC HIV / AIDS Program', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Hosp / Infectious Diseases', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '55407', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Abbott Northwestern Hosp', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Kansas City AIDS 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'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Med Univ of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '37212', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt Univ Med Ctr', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Metroplex Clinical Research Ctr', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77555', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'Univ of Texas Med Branch Ctr for Clinical Studies', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}, {'zip': '77027', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'ONCOL Med Associates / PA', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84108', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Univ of Utah 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'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Immune Response Corporation', 'class': 'INDUSTRY'}}}}