Ignite Creation Date:
2025-12-24 @ 9:41 PM
Ignite Modification Date:
2025-12-30 @ 2:00 AM
Study NCT ID:
NCT00046332
Status:
COMPLETED
Last Update Posted:
2013-02-21
First Post:
2002-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Comparing 4 Doses Of GW810781 Versus Placebo In HIV-Infected Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-06'}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2003-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-20', 'studyFirstSubmitDate': '2002-09-26', 'studyFirstSubmitQcDate': '2002-09-27', 'lastUpdatePostDateStruct': {'date': '2013-02-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma HIV-1 RNA change from baseline by Day 11.'}], 'secondaryOutcomes': [{'measure': 'HIV-1 RNA slope over 11 days; proportion of subjects with treatment-limiting adverse events; change from baseline in CD4+ cell count at Day 11; plasma pharmacokinetics by dose; emergence of viral resistance.'}]}, 'conditionsModule': {'keywords': ['Integrase inhibitors', 'Monotherapy', 'HIV-1 infection'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the drop in viral load over 10 days of treatment with S-1360 versus placebo in HIV-infected patients who have not previously taken anti-HIV medications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No prior HIV medications.\n* HIV infection with viral load \\>400-50,000 copies/mL.\n* CD4 cell count \\>50 cells/mm.\n\nExclusion Criteria:\n\n* Patients requiring medications that cannot be interrupted for the duration of the study.\n* Abnormal ECG or other chronic health conditions as noted on screening physical exam.\n* Previous participation in an experimental drug trial(s) within 30 days of the screening visit for this study.'}, 'identificationModule': {'nctId': 'NCT00046332', 'briefTitle': 'A Study Comparing 4 Doses Of GW810781 Versus Placebo In HIV-Infected Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Phase II, Randomized, Placebo-controlled Study to Compare Antiviral Effect, Safety, Tolerability and Pharmacokinetics of Four Oral Doses of S-1360 Versus Placebo Over 10 Days in ART-naive HIV-1 Infected Adults.', 'orgStudyIdInfo': {'id': 'ITG20001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'GW810781', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '90069', 'city': 'West Hollywood', 'state': 'California', 'country': 'United States', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 34.09001, 'lon': -118.36174}}, {'zip': '80220', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32701', 'city': 'Altamonte Springs', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 28.66111, 'lon': -81.36562}}, {'zip': '33311', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33133', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33614', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '55404', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '10008', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10011', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '28203', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77004', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'GSK Clinical Trial, MD,MPH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Shionogi', 'class': 'INDUSTRY'}]}}}