Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-25 @ 5:17 PM
Study NCT ID:
NCT00000803
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase II Double-Blind Study of Delavirdine Mesylate ( U-90152 ) in Combination With Zidovudine ( AZT ) and/or Didanosine ( ddI ) Versus AZT and ddI Combination Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'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': 'D020008', 'term': 'Delavirdine'}, {'id': 'D015215', 'term': 'Zidovudine'}, {'id': 'D016049', 'term': 'Didanosine'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D013936', 'term': 'Thymidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D015224', 'term': 'Dideoxynucleosides'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D007288', 'term': 'Inosine'}, {'id': 'D011684', 'term': 'Purine Nucleosides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D012263', 'term': 'Ribonucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 471}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '1997-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-27', 'studyFirstSubmitDate': '1999-11-02', 'studyFirstSubmitQcDate': '2001-08-30', 'lastUpdatePostDateStruct': {'date': '2021-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2001-08-31', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Didanosine', 'Drug Therapy, Combination', 'Acquired Immunodeficiency Syndrome', 'AIDS-Related Complex', 'Antiviral Agents', 'Zidovudine'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Griffit B, Morse G, Demeter L, Bassett R, Hughes M, Friedland G. Relationship between delavirdine (DLV) plasma levels, HIV RNA responses and DLV resistance during combination therapy with zidovudine (ZDV), and didanosine (ddI). Int Conf AIDS. 1998;12:52 (abstract no 12206)'}, {'type': 'BACKGROUND', 'citation': 'Freimuth WW, Chuang-Stein CJ, Greenwald CA, Wathen LK, Edge-Padbury BA, Cox SR, Daenzer CL, Wang Y, Carberry PA. Delavirdine (DLV) combined with zidovudine (ZDV) or didanosine (ddI) produces sustained reduction in viral burden and increases in CD4 count in early and advanced HIV-1 infection. Int Conf AIDS. 1996 Jul 7-12;11(1):22 (abstract no MoB295)'}, {'type': 'BACKGROUND', 'citation': 'Nokta M, Turk P. Partial restoration of HIV specific neutralizing activity (NA) of HIV infected patients receiving antiretrovial therapy: DDI/delaviridine (DLV), AZT/DLV, DDI/AZT or DDI/AZT/DLV. Int Conf AIDS. 1998;12:516 (abstract no 31108)'}, {'pmid': '10428106', 'type': 'BACKGROUND', 'citation': 'Friedland GH, Pollard R, Griffith B, Hughes M, Morse G, Bassett R, Freimuth W, Demeter L, Connick E, Nevin T, Hirsch M, Fischl M. Efficacy and safety of delavirdine mesylate with zidovudine and didanosine compared with two-drug combinations of these agents in persons with HIV disease with CD4 counts of 100 to 500 cells/mm3 (ACTG 261). ACTG 261 Team. J Acquir Immune Defic Syndr. 1999 Aug 1;21(4):281-92. doi: 10.1097/00126334-199908010-00005.'}, {'pmid': '9052722', 'type': 'BACKGROUND', 'citation': 'Demeter LM, Meehan PM, Morse G, Gerondelis P, Dexter A, Berrios L, Cox S, Freimuth W, Reichman RC. HIV-1 drug susceptibilities and reverse transcriptase mutations in patients receiving combination therapy with didanosine and delavirdine. J Acquir Immune Defic Syndr Hum Retrovirol. 1997 Feb 1;14(2):136-44. doi: 10.1097/00042560-199702010-00006.'}]}, 'descriptionModule': {'briefSummary': 'To determine the safety and anti-HIV activity of delavirdine mesylate ( U-90152 ) in combination with zidovudine ( AZT ) and/or didanosine ( ddI ) versus AZT/ddI combination.\n\nU-90152 has demonstrated anti-HIV activity. Since the combination of this drug with either AZT or ddI has synergistic inhibitory activity against HIV-1 in vitro, and triple therapy appears to have greater inhibitory activity against HIV-1 in vitro than dual therapy, the use of U-90152 in combination with AZT and/or ddI may improve the benefits of these drugs in persons with HIV disease.', 'detailedDescription': 'U-90152 has demonstrated anti-HIV activity. Since the combination of this drug with either AZT or ddI has synergistic inhibitory activity against HIV-1 in vitro, and triple therapy appears to have greater inhibitory activity against HIV-1 in vitro than dual therapy, the use of U-90152 in combination with AZT and/or ddI may improve the benefits of these drugs in persons with HIV disease.\n\nPatients are randomized to receive U-90152/AZT/ddI, U-90152/AZT, U-90152/ddI, or AZT/ddI for 48 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\nConcurrent Medication:\n\nRequired:\n\n* PCP prophylaxis for patients with CD4 count \\<= 200 cells/mm3.\n\nAllowed:\n\n* Topical antifungal agents.\n* Oral ketoconazole, fluconazole, and itraconazole for candidiasis or disseminated fungal infections.\n* Isoniazid, ethambutol, pyrazinamide, clofazimine, ciprofloxacin, and clarithromycin for acute or maintenance therapy for mycobacterial disease (also clarithromycin for MAC prophylaxis).\n* Acute or maintenance therapy for toxoplasmosis.\n* Acute or maintenance therapy with acyclovir (no more than 1000 mg/day) for herpes simplex virus infection.\n* rEPO and rG-CSF.\n* Antibiotics for bacterial infections (except rifampin and rifabutin).\n* Antipyretics, analgesics, nonsteroidal anti-inflammatory agents, antiemetics, and methadone.\n\nConcurrent Treatment:\n\nAllowed for cutaneous Kaposi's sarcoma:\n\n* Localized radiation therapy.\n* Limited intralesional therapy.\n\nPatients must have:\n\n* HIV infection.\n* CD4 count 100 - 500 cells/mm3.\n* Prior cumulative monotherapy of \\<= 6 months (may have taken either AZT or ddI, but not both) OR no prior antiretroviral therapy.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\n* Malignancy (other than basal or squamous cell carcinoma of the skin, Stage 1 or 2 cervical intraepithelial neoplasia, or minimal Kaposi's sarcoma).\n* Considered to be unlikely to comply with study requirements.\n\nConcurrent Medication:\n\nExcluded:\n\n* Antiretroviral therapies and biologic response modifiers (except for study medications, rEPO, and rG-CSF).\n* Rifampin.\n* Rifabutin.\n* Terfenadine.\n* Astemizole.\n* Loratadine.\n* Quinidine.\n* Digitoxin.\n* Systemic corticosteroids for more than 21 consecutive days.\n* Foscarnet.\n* Systemic cytotoxic chemotherapy for a malignancy.\n\nPatients with the following prior conditions are excluded:\n\n* History of intolerance to AZT at \\<= 600 mg/day or ddI at \\<= 400 mg/day or discontinuation of either drug for toxicity.\n* History of intolerance to trifluoperazine or piperazine citrate (per amendment).\n* History of pancreatitis.\n* History of grade 2 or worse peripheral neuropathy.\n* Unexplained temperature \\>= 38.5 C on any 7 days within the past 30 days.\n* Chronic diarrhea on any 15 days during the past 30 days.\n\nPrior Medication:\n\nExcluded:\n\n* Prior foscarnet as induction or maintenance therapy.\n* Prior U-90152.\n* Prior ddC or d4T.\n* Prior AZT/ddI in combination or taken separately at different times.\n* Prior non-nucleoside reverse transcriptase inhibitors (nevirapine, atevirdine, etc.).\n* Prior protease inhibitors (although patients from ACTG 282 are eligible).\n* HIV-1 vaccine within the past 21 days.\n* Acute treatment for a serious infection or for any opportunistic infection within the past 14 days.\n\nExcluded within the past 30 days:\n\n* Interferon or interleukin.\n* Rifampin.\n* Rifabutin.\n* Terfenadine.\n* Astemizole.\n* Loratadine.\n* Recombinant EPO or G-CSF.\n* Hydroxyurea.\n* SPV-30.\n* Any other investigational drug.\n\nActive drug or alcohol use."}, 'identificationModule': {'nctId': 'NCT00000803', 'briefTitle': 'A Phase II Double-Blind Study of Delavirdine Mesylate ( U-90152 ) in Combination With Zidovudine ( AZT ) and/or Didanosine ( ddI ) Versus AZT and ddI Combination Therapy', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'A Phase II Double-Blind Study of Delavirdine Mesylate ( U-90152 ) in Combination With Zidovudine ( AZT ) and/or Didanosine ( ddI ) Versus AZT and ddI Combination Therapy', 'orgStudyIdInfo': {'id': 'ACTG 261'}, 'secondaryIdInfos': [{'id': '11238', 'type': 'REGISTRY', 'domain': 'DAIDS-ES Registry Number'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Delavirdine mesylate', 'type': 'DRUG'}, {'name': 'Zidovudine', 'type': 'DRUG'}, {'name': 'Didanosine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama Therapeutics CRS', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC CRS', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford CRS', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Ucsd, Avrc Crs', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Ucsf Aids Crs', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Hospital CRS', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '20059', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Howard University Hosp., Div. of Infectious Diseases, ACTU', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '331361013', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Univ. of Miami AIDS CRS', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '96816', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Queens Med. Ctr.', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Univ. of Hawaii at Manoa, Leahi Hosp.', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '462025250', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana Univ. School of Medicine, Infectious Disease Research Clinic', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Methodist Hosp. of Indiana', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Adult AIDS CRS', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital ACTG CRS', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Bmc Actg Crs', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess - East Campus A0102 CRS', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Med. Ctr., ACTG CRS', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota, ACTU', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington U CRS', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63112', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'St. Louis ConnectCare, Infectious Diseases Clinic', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '14215', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY - Buffalo, Erie County Medical Ctr.', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Cornell University A2201', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Beth Israel Med. Ctr. (Mt. Sinai)', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Ctr.', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NY Univ. HIV/AIDS CRS', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Univ. of Rochester ACTG CRS', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '452670405', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Univ. of Cincinnati CRS', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Case CRS', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '432101228', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State Univ. AIDS CRS', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hosp. of the Univ. of Pennsylvania CRS', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '981224304', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington AIDS CRS', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '009365067', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Puerto Rico-AIDS CRS', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'overallOfficials': [{'name': 'Friedland G', 'role': 'STUDY_CHAIR'}, {'name': 'Fischl MA', 'role': 'STUDY_CHAIR'}, {'name': 'Pollard R', 'role': 'STUDY_CHAIR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}