Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
Study NCT ID:
NCT00002320
Status:
COMPLETED
Last Update Posted:
2005-12-12
First Post:
1999-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Comparison of Lamivudine and Zidovudine, Used Alone and Together, in HIV-Infected Patients Who Have Not Used Zidovudine in the Past
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': 'D019259', 'term': 'Lamivudine'}, {'id': 'D015215', 'term': 'Zidovudine'}], 'ancestors': [{'id': 'D016047', 'term': 'Zalcitabine'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D015224', 'term': 'Dideoxynucleosides'}, {'id': 'D013936', 'term': 'Thymidine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 320}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '1994-05', 'lastUpdateSubmitDate': '2005-12-08', 'studyFirstSubmitDate': '1999-11-02', 'studyFirstSubmitQcDate': '2001-08-30', 'lastUpdatePostDateStruct': {'date': '2005-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2001-08-31', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Drug Therapy, Combination', 'Acquired Immunodeficiency Syndrome', 'AIDS-Related Complex', 'Antiviral Agents', 'Zidovudine'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '9030391', 'type': 'BACKGROUND', 'citation': 'Eron JJ Jr. The treatment of antiretroviral-naive subjects with the 3TC/zidovudine combination: a review of North American (NUCA 3001) and European (NUCB 3001) trials. AIDS. 1996 Dec;10 Suppl 5:S11-9. doi: 10.1097/00002030-199612005-00003.'}, {'pmid': '8853730', 'type': 'BACKGROUND', 'citation': 'Kuritzkes DR, Quinn JB, Benoit SL, Shugarts DL, Griffin A, Bakhtiari M, Poticha D, Eron JJ, Fallon MA, Rubin M. Drug resistance and virologic response in NUCA 3001, a randomized trial of lamivudine (3TC) versus zidovudine (ZDV) versus ZDV plus 3TC in previously untreated patients. AIDS. 1996 Aug;10(9):975-81. doi: 10.1097/00002030-199610090-00007.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and efficacy of high-dose lamivudine (3TC) alone versus zidovudine (AZT) alone versus 3TC at high and low doses in combination with AZT in HIV-1 infected patients.\n\nPER 02/27/95 AMENDMENT: To evaluate the efficacy and safety of both blinded and open-label combination therapy.', 'detailedDescription': 'Patients are randomized to one of four treatment arms: 3TC alone, AZT alone, low-dose 3TC plus AZT, or high-dose 3TC plus AZT. Patients receive treatment for 32 weeks, with possible extension to 52 weeks.\n\nPER 02/27/95 AMENDMENT: Patients may continue therapy on AZT and low-dose 3TC on an open-label basis. Open-label therapy continues with follow-up every 8 weeks until intolerable toxicity occurs or study terminates.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nPatients must have:\n\n* HIV positivity.\n* CD4 count 200-500 cells/mm3.\n* AZT naive status (\\<= 4 weeks of prior AZT).\n\nExclusion Criteria\n\nPatients with the following prior condition are excluded:\n\nHistory of intolerance to AZT.\n\nPrior Medication:\n\nExcluded:\n\n* More than 4 weeks of prior AZT.\n* Any prior antiretroviral treatment other than AZT.'}, 'identificationModule': {'nctId': 'NCT00002320', 'briefTitle': 'A Comparison of Lamivudine and Zidovudine, Used Alone and Together, in HIV-Infected Patients Who Have Not Used Zidovudine in the Past', 'organization': {'class': 'INDUSTRY', 'fullName': 'NIH AIDS Clinical Trials Information Service'}, 'officialTitle': 'A Randomized, Double-Blind Multicenter Trial to Compare the Safety and Efficacy of Lamivudine (3TC; GR109714X) Monotherapy Versus Zidovudine (AZT) Monotherapy Versus 3TC Administered With AZT in the Treatment of HIV-1 Infected Patients Who Are AZT Naive (< 4 Weeks) With CD4 Cell Counts of 200-500 Cells/mm3', 'orgStudyIdInfo': {'id': '129B'}, 'secondaryIdInfos': [{'id': 'NUCA 3001'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Lamivudine', 'type': 'DRUG'}, {'name': 'Zidovudine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90028', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Combat Group', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92104', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'San Diego Community Research Group', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '91403', 'city': 'Sherman Oaks', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Oaks Med Group', 'geoPoint': {'lat': 34.15112, 'lon': -118.44925}}, {'zip': '90509', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Harbor - UCLA Med Ctr', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '33614', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Infectious Disease Research Institute Inc', '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': '60607', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Chicago Ctr for Clinical Research', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '70119', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Louisiana Cardiovascular Research Ctr', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '02445', 'city': 'Brookline', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'CRI of New England', 'geoPoint': {'lat': 42.33176, 'lon': -71.12116}}, {'zip': '10019', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "Saint Luke's - Roosevelt Hosp Ctr", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '275997215', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Univ of North Carolina School of Medicine', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '43699', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'Med College of Ohio', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '97210', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Portland Veterans Adm Med Ctr / Rsch & Education Grp', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '02860', 'city': 'Pawtucket', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Mem Hosp of Rhode Island', 'geoPoint': {'lat': 41.87871, 'lon': -71.38256}}, {'zip': '78751', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Central Texas Med Foundation', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Nicholaos Bellos', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '23219', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Richmond AIDS Consortium', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '53202', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Wisconsin Community - Based Research Consortium', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Ottawa General Hospital', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto Hosp', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Montreal Gen Hosp', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '00908', 'city': 'Santurce', 'country': 'Puerto Rico', 'facility': 'Advance Community Health Services Inc', 'geoPoint': {'lat': 18.19523, 'lon': -67.14018}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glaxo Wellcome', 'class': 'INDUSTRY'}}}}