Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2025-12-25 @ 8:06 PM
Study NCT ID:
NCT00002035
Status:
COMPLETED
Last Update Posted:
2011-08-05
First Post:
1999-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Double-Blind Comparison of the Efficacy of Continued Zidovudine Versus 2',3'-Dideoxyinosine (ddI) (BMY-40900) for the Treatment of Patients With AIDS or AIDS-Related Complex and Increasing Symptomatology Despite Treatment With Zidovudine
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': 'D015215', 'term': 'Zidovudine'}, {'id': 'D016049', 'term': 'Didanosine'}], 'ancestors': [{'id': 'D013936', 'term': 'Thymidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D012263', 'term': 'Ribonucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '1992-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-04', 'studyFirstSubmitDate': '1999-11-02', 'studyFirstSubmitQcDate': '2001-08-30', 'lastUpdatePostDateStruct': {'date': '2011-08-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2001-08-31', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Didanosine', 'Acquired Immunodeficiency Syndrome', 'AIDS-Related Complex', 'Zidovudine'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Ruedy N, et al. Results of long term follow-up of a double blind study of ddI vs continued AZT among individuals with CD4s 200-500/mm3. Int Conf AIDS. 1994 Aug 7-12;10(2):16 (abstract no 358B)'}]}, 'descriptionModule': {'briefSummary': 'To compare the efficacy and safety of orally administered didanosine (ddI) with orally administered zidovudine (AZT) in the treatment of patients who exhibit increasing clinical deterioration despite treatment with AZT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed for Hematologic toxicity:\n\n* Erythropoietin.\n* Colony-Stimulating Factors.\n* Allowed for prophylaxis of Pneumocystis carinii pneumonia (PCP):\n* Aerosolized pentamidine.\n* Trimethoprim/sulfamethoxazole.\n* Dapsone.\n* NOTE:\n* If intravenous pentamidine is required for treatment of PCP, study drug should be suspended until one week after completion of intravenous pentamidine.\n* Allowed:\n* Prophylactic or suppressive therapy begun prior to study entry with the exception of neurotoxic agents (as defined in the protocol).\n\nConcurrent Treatment:\n\nAllowed:\n\n* Transfusions for hematologic toxicity.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following conditions or symptoms are excluded:\n\n* Active acute AIDS defining infection.\n* Clinical evidence of acute pancreatitis in the last two years or chronic pancreatitis.\n* Dementia of such severity that patient cannot give informed consent.\n* Grade 2 or worse peripheral neuropathy as defined by Targeted Neuropathy Score (Schaumberg).\n* Prior Cytomegalovirus disease requiring ongoing systemic ganciclovir therapy.\n* Extensive Kaposi's sarcoma or other malignancy requiring systemic cytotoxic myelosuppressive or neurotoxic chemotherapy.\n* Cardiomyopathy or the need for antiarrhythmic therapy.\n* Inability to tolerate at least 600 mg per day of zidovudine (AZT).\n* Seizures within the last 6 months or the need for anticonvulsant therapy.\n\nConcurrent Medication:\n\nExcluded:\n\n* Ganciclovir (DHPG).\n* Myelosuppressive or neurotoxic chemotherapy.\n* Antiarrhythmic therapy.\n* Anticonvulsant therapy.\n* Neurotoxic agents (as defined in the protocol).\n* NOTE:\n* If intravenous pentamidine is required for treatment of Pneumocystis carinii pneumonia (PCP), study drug should be suspended until 1 week after completion of intravenous pentamidine.\n\nPatients with the following are excluded:\n\n* Symptoms and conditions defined in the Patient Exclusion Co-Existing Conditions field.\n* Average of two sequential CD4 counts from SciCor Clinical Laboratories in the 30 days prior to study entry \\> 300 cells/mm3.\n\nPrior Medication:\n\nExcluded, participation in studies using:\n\n* Dideoxyinosine (ddI).\n* 2',3'-Dideoxy-2',3'-didehydrothymidine (d4T).\n* Dideoxycytidine (ddC).\n* Excluded within one month of study entry:\n* Any other experimental antiretroviral compounds.\n\nPatients must:\n\n* Have documented HIV positivity via ELISA.\n* Meet CDC criteria for AIDS or AIDS related complex (ARC).\n* Have received zidovudine (AZT) for = or \\> 6 months and tolerated a dose of at least 500 mg per day without significant hematologic toxicity.\n* Have no acute AIDS defining opportunistic infection, but may be receiving suppressive therapy for such infections.\n* Demonstrate at least one of the following criteria for clinical deterioration despite AZT therapy within 4 weeks prior to study entry (8 weeks prior for weight loss):\n* involuntary weight loss of more than 5 percent of the body weight occurring over the 8 week period prior to study entry, Karnofsky score = or \\> 50 but demonstrating a fall = or \\> 20 from previous level of functioning (assessment must be persistent on two occasions at least 14 days apart), unexplained fever of = or \\> 38 degrees C (despite evaluation defined in protocol) for more than 7 days, appearance of newly diagnosed oral hairy leukoplakia or oral candidiasis, or recurrence of a previously quiescent multidermatomal varicella-zoster, appearance of dermatologic afflictions (e.g. psoriasis, molluscum contagiosum, or newly diagnosed seborrheic dermatitis), appearance of chronic herpetic ulcers not responsive to acyclovir therapy.\n\nRequired:\n\n* Zidovudine (AZT) for = or \\> 6 months prior to study entry."}, 'identificationModule': {'nctId': 'NCT00002035', 'briefTitle': "Double-Blind Comparison of the Efficacy of Continued Zidovudine Versus 2',3'-Dideoxyinosine (ddI) (BMY-40900) for the Treatment of Patients With AIDS or AIDS-Related Complex and Increasing Symptomatology Despite Treatment With Zidovudine", 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': "Double-Blind Comparison of the Efficacy of Continued Zidovudine Versus 2',3'-Dideoxyinosine (ddI) (BMY-40900) for the Treatment of Patients With AIDS or AIDS-Related Complex and Increasing Symptomatology Despite Treatment With Zidovudine", 'orgStudyIdInfo': {'id': '039B'}, 'secondaryIdInfos': [{'id': 'AI454-010'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Zidovudine', 'type': 'DRUG'}, {'name': 'Didanosine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Univ of Arizona / Health Science Ctr', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale Univ Med School', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '33316', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'G E Morey Jr', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'VP Med Services / HHCS Research Institute Inc', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'AIDS Research Consortium of Atlanta', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60141', 'city': 'Hines', 'state': 'Illinois', 'country': 'United States', 'facility': 'Edward Hines Veterans Administration Hosp', 'geoPoint': {'lat': 41.85364, 'lon': -87.8395}}, {'zip': '67214', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Univ of Kansas School of Medicine', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Harper Hosp', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '12203', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Albany Med College / AIDS Treatment Ctr', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '43699', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'Med College of Ohio', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Univ of Pennsylvania / HIV Clinic', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Univ of Texas Southwestern Med Ctr of Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '775550882', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'Univ TX Galveston Med Branch', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}, {'zip': '78284', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Audie L Murphy Veterans Administration Hosp', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Univ of Utah School of Medicine', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '23666', 'city': 'Hampton', 'state': 'Virginia', 'country': 'United States', 'facility': 'Dr Stephen L Green', 'geoPoint': {'lat': 37.02987, 'lon': -76.34522}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Milwaukee County Med Complex', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '009275800', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'UPR School of Medicine', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}}}}