Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-29 @ 2:35 AM
Study NCT ID:
NCT00002203
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Two Anti-HIV Drug Combinations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D010349', 'term': 'Patient Compliance'}], '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': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C109078', 'term': 'lamivudine, zidovudine drug combination'}, {'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '1998-11', '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': ['Drug Therapy, Combination', 'Zidovudine', 'HIV Protease Inhibitors', 'CD4 Lymphocyte Count', 'CD4-CD8 Ratio', 'Lamivudine', 'Patient Compliance', 'Reverse Transcriptase Inhibitors', 'Anti-HIV Agents', 'Viral Load'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the safety and effectiveness of taking lamivudine (3TC) plus zidovudine (ZDV) plus a protease inhibitor (PI) with taking the 3TC/ZDV combination tablet (Combivir) plus a PI. This study also examines how well patients follow the dosing schedules for these drugs.\n\nDoctors believe that taking Combivir plus a PI may be as effective as taking 3TC plus ZDV plus a PI.', 'detailedDescription': 'It is hypothesized that a fixed-dose 3TC/ZDV tablet given bid in combination with a protease inhibitor is clinically equivalent in its effect on plasma HIV-1 RNA level to a conventional regimen of 3TC, ZDV, and a protease inhibitor.\n\nPatients are stratified according to their current protease inhibitor therapy and randomized to receive open-label therapy of 1 Combivir tablet bid (Arm II) or an equivalent dose of 3TC and ZDV (Arm I), plus their current protease inhibitor for 16 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\nPatients must have:\n\n* HIV infection documented by a licensed antibody ELISA assay and confirmed by Western blot, positive HIV blood culture, positive HIV serum antigen, or plasma viremia.\n* CD4+ cell count of at least 300 cells/mm3.\n* HIV-1 RNA less than 10,000 copies/ml by Roche Amplicor PCR assay.\n* CDC Category A or B Classification for HIV infection (no clinical diagnosis of AIDS).\n* Compliance with dosing schedule and protocol evaluations.\n\nPrior Medication:\n\nRequired:\n\n* 3TC at 150 mg bid, ZDV at 600 mg/day (200 mg tid or 300 mg bid), plus a marketed protease inhibitor (ritonavir, saquinavir, indinavir, or nelfinavir) at its recommended dose for at least 10 weeks.\n\nAllowed:\n\n* Inhaled corticosteroids for the treatment of asthma.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following conditions or symptoms are excluded:\n\n* Malabsorption syndromes affecting drug absorption (e.g., Crohn's disease and chronic pancreatitis).\n* Enrollment in other investigational protocols.\n\nConcurrent Medication:\n\nExcluded:\n\n* Cytotoxic chemotherapeutic agents.\n* Nonnucleoside reverse transcriptase inhibitors.\n* Other investigational agents.\n\nConcurrent Treatment:\n\nExcluded:\n\nRadiation therapy.\n\nPrior Medication:\n\nExcluded:\n\n* Cytotoxic chemotherapeutic and immunomodulating agents such as systemic corticosteroids, IF-2, alpha-IFN, beta-IFN, or gamma-IFN (except for inhaled corticosteroids for the treatment of asthma) within 4 weeks of study entry.\n* HIV immunotherapeutic vaccine within 3 months of study entry.\n\nPrior Treatment:\n\nExcluded:\n\nRadiation therapy within 4 weeks of study entry."}, 'identificationModule': {'nctId': 'NCT00002203', 'briefTitle': 'A Study of Two Anti-HIV Drug Combinations', 'organization': {'class': 'INDUSTRY', 'fullName': 'NIH AIDS Clinical Trials Information Service'}, 'officialTitle': 'A Randomized, Multicenter Study of Epivir 150 Mg Bid, Retrovir 200 Mg Tid and a Protease Inhibitor Vs 3TC 150 Mg/ZDV 300 Mg Fixed Dose Tablet Given Bid With a Protease Inhibitor in HIV-Infected Patients', 'orgStudyIdInfo': {'id': '280A'}, 'secondaryIdInfos': [{'id': 'NZTA4001'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Lamivudine/Zidovudine', 'type': 'DRUG'}, {'name': 'Lamivudine', 'type': 'DRUG'}, {'name': 'Zidovudine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Oaks Med Ctr', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Tower Infectious Diseases / Med Associates Inc', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Univ of North Carolina Hosps', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '28232', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolinas Med Ctr', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '22003', 'city': 'Annandale', 'state': 'Virginia', 'country': 'United States', 'facility': 'Infectious Diseases Physicians Inc', 'geoPoint': {'lat': 38.83039, 'lon': -77.19637}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Univ of Wisconsin School of Medicine', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '00907', 'city': 'Santurce', 'country': 'Puerto Rico', 'facility': 'San Juan AIDS Program', 'geoPoint': {'lat': 18.19523, 'lon': -67.14018}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glaxo Wellcome', 'class': 'INDUSTRY'}}}}