Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2025-12-27 @ 2:42 AM
Study NCT ID:
NCT01458132
Status:
COMPLETED
Last Update Posted:
2019-09-11
First Post:
2011-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Drug Exposure Registry for GSK2248761, an Investigational NNRTI
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D012640', 'term': 'Seizures'}], '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': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 17 months', 'description': 'All Subject Population was used', 'eventGroups': [{'id': 'EG000', 'title': 'Participants Without Seizure', 'description': 'Participants who were previously randomized in the Phase 2b studies SGN113399 or SGN113404 (randomized to Fosdevirine) and did not experience seizure during the follow-up period, after exposure to Fosdevirine, at 100 or 200 mg, for atleast four weeks in the Phase 2b trials.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 15, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Participants With Seizure', 'description': 'Participants who were previously randomized in the Phase 2b studies SGN113399 or SGN113404 (randomized to Fosdevirine) and experienced seizure during the follow-up period, after exposure to fosdevirine, at 100 or 200 mg, for atleast four weeks in the Phase 2b trials.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Eye abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Gastroenteritis salmonella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hip arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Intervertebral disc disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Myopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Skin lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Tobacco withdrawal symptom', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Vaginal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'seriousEvents': [{'term': 'Staphylococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Occurrence of Seizure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Without Seizure', 'description': 'Participants who were previously randomized in the Phase 2b studies SGN113399 or SGN113404 (randomized to Fosdevirine) and did not experience seizure during the follow-up period, after exposure to Fosdevirine, at 100 or 200 mg, for atleast four weeks in the Phase 2b trials.'}, {'id': 'OG001', 'title': 'Participants With Seizure', 'description': 'Participants who were previously randomized in the Phase 2b studies SGN113399 or SGN113404 (randomized to Fosdevirine) and experienced seizure during the follow-up period, after exposure to fosdevirine, at 100 or 200 mg, for atleast four weeks in the Phase 2b trials.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 17 months', 'description': 'In the registry study from start to the end of follow-up, the number of participants who experienced seizure were reported. This was done to evaluate to test the time-efficiency and cost-efficiency for a long term, non-interventional study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Subject Population, defined as all participants, who consented to participate in the registry study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serious Adverse Event (SAE) and Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Without Seizure', 'description': 'Participants who were previously randomized in the Phase 2b studies SGN113399 or SGN113404 (randomized to Fosdevirine) and did not experience seizure during the follow-up period, after exposure to Fosdevirine, at 100 or 200 mg, for atleast four weeks in the Phase 2b trials.'}, {'id': 'OG001', 'title': 'Participants With Seizure', 'description': 'Participants who were previously randomized in the Phase 2b studies SGN113399 or SGN113404 (randomized to Fosdevirine) and experienced seizure during the follow-up period, after exposure to fosdevirine, at 100 or 200 mg, for atleast four weeks in the Phase 2b trials.'}], 'classes': [{'title': 'Any AE', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Any SAE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Upto 17 months', 'description': 'An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Subject Population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Participants Without Seizure', 'description': 'Participants who were previously randomized in the Phase 2b studies SGN113399 or SGN113404 (randomized to Fosdevirine) and did not experience seizure during the follow-up period, after exposure to Fosdevirine, at 100 or 200 milligram (mg), for atleast four weeks in the Phase 2b trials.'}, {'id': 'FG001', 'title': 'Participants With Seizure', 'description': 'Participants who were previously randomized in the Phase 2b studies SGN113399 or SGN113404 and experienced seizure during the follow-up period , after exposure to fosdevirine, at 100 or 200 mg, for atleast four weeks in the Phase 2b trials.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'The study was conducted from 06 September 2011 to 25 February 2013, at 19 sites in 4 countries, France, Romania, United States, and Germany.', 'preAssignmentDetails': 'Of the 35 Fosdevirine -exposed participants, 19 consented to enroll in the registry, including 4 of the 5 seizure participants and 15 from the non-seizure group.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Participants Without Seizure', 'description': 'Participants who were previously randomized in the Phase 2b studies SGN113399 or SGN113404 (randomized to Fosdevirine ) and did not experience seizure during the follow-up period, after exposure to Fosdevirine, at 100 or 200 mg, for atleast four weeks in the Phase 2b trials.'}, {'id': 'BG001', 'title': 'Participants With Seizure', 'description': 'Participants who were previously randomized in the Phase 2b studies SGN113399 or SGN113404 and experienced seizure during the follow-up period , after exposure to fosdevirine, at 100 or 200 mg, for atleast four weeks in the Phase 2b trials.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All Subject Population: all participants who consented to participate in the registry study.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2013-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-31', 'studyFirstSubmitDate': '2011-09-01', 'resultsFirstSubmitDate': '2017-09-16', 'studyFirstSubmitQcDate': '2011-10-20', 'lastUpdatePostDateStruct': {'date': '2019-09-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-07-31', 'studyFirstPostDateStruct': {'date': '2011-10-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-09-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Occurrence of Seizure', 'timeFrame': 'Up to 17 months', 'description': 'In the registry study from start to the end of follow-up, the number of participants who experienced seizure were reported. This was done to evaluate to test the time-efficiency and cost-efficiency for a long term, non-interventional study.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Serious Adverse Event (SAE) and Adverse Event (AE)', 'timeFrame': 'Upto 17 months', 'description': 'An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['subject follow-up', 'HIV infection', 'registry', 'seizures', 'GSK2248761'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': "The World Health Organization has estimated that as many as 10% of the population worldwide may at some point experience at least one seizure. The percentage with active epilepsy is from 0.4% to 1%. From 40% to 65% of patients with HIV infection have been estimated to have some neurological involvement; the percentage reaches as high as 70% to 80% when post-mortem assessments are included. Estimates of the percentage of HIV-infected patients with seizure occurrence have varied widely, with one review finding a range from 2% to 20%. The highest percentage in this range was reported at a center that exclusively treated patients with neurological involvement, in India where HIV clade C subtype is predominant. Query of another neurology department's database determined that of the HIV-infected patients treated at the center, all of whom were referred for neurological symptoms, 6.1% experienced seizures. Underlying neurologic diseases in these patients included HIV-associated encephalopathy, progressive multifocal leukoencephalopathy, and toxoplasmosis. In a Spanish population, 3% of HIV-infected patients over a one-year study period were found to have new-onset seizures, which were attributed to drug toxicity in 47%, intracranial lesions in 35%, and metabolic derangements in 12%.\n\nDrug-discontinuation studies, magnetic resonance imaging studies, and animal studies have produced recent evidence that some antiretroviral therapies may have neurotoxic effects, warranting further research. Individuals who are treated with highly active antiretroviral therapy are at risk for immune reconstitution inflammatory syndrome (IRIS), in which immune recovery triggers clinical deterioration as the newly invigorated immune system reacts to pathogens that either represent ongoing opportunistic infection or were previously successfully controlled. In a population initiating combination antiretroviral therapy between 1999 and 2007, 0.9% developed neurological manifestations of IRIS. Seizures may occur as part of a neurological IRIS syndrome, such as encephalitis and toxoplasmosis.\n\nTwo randomized, Phase 2b dose-finding studies were conducted in HIV-1 infected adults to compare GSK2248761 100 mg and 200 mg given once daily as part of an antiretroviral treatment regimen. One of the studies (SGN113399) was in subjects with prior exposure to antiretroviral therapy where GSK2248761 100 mg and 200 mg once daily were compared to determine the best dose in this population. A contemporary control arm receiving etravirine 200 mg twice daily was also included, and all arms included a twice-daily background therapy consisting of darunavir/ritonavir 600 mg/100 mg plus raltegravir 400 mg. The other study (SGN113404) was in treatment-naïve subjects, comparing GSK2248761 100 mg and 200 mg once daily to determine the best dose in this population. A contemporary control arm receiving efavirenz 600 mg once daily was also included, and all arms were given background therapy selected by investigators from either once-daily abacavir/lamivudine 600 mg/300 mg or tenofovir/emtricitabine 300 mg/200 mg. Of a planned total population in both studies of 300 subjects, 35 were enrolled before the studies were terminated because of the occurrence of seizures in five subjects. All of the subjects who experienced seizures were enrolled into SGN113399, four randomized to receive 200 mg GSK2248761 and one randomized to receive 100 mg GSK2248761. There were no seizures in the subjects receiving GSK2248761 in study SGN113404. At the time of study termination, subjects had been enrolled and received GSK2248761 at 19 sites in four countries: France, Romania, United States, and Germany. Although potential contributory conditions have been identified in some cases, definitive causative factors for the seizure occurrence have not been established.\n\nThe purpose of this study is to follow subjects who previously received GSK2248761 while enrolled in the Phase 2b studies, which were halted due to unexpected seizures. The study will collect data on all subjects and will be used to monitor for additional seizures as well as collect additional clinical data on all subjects.", 'detailedDescription': 'The objective of the study is to collect and monitor data on all subjects who previously received GSK2248761 while enrolled in the Phase 2b studies SGN113399 or SGN113404 evaluating GSK2248761. There will be no formal hypotheses tested, and the data collected will be utilized to build individual subject narratives for each subject.\n\nAll subjects who were previously randomized in the Phase 2b studies SGN113399 or SGN113404 and received GSK2248761, will be targeted for enrollment in the study. Study SGN11339 had 20 subjects randomized to receive GSK2248761 and was conducted at 12 sites in the United States and one site in Romania. Study SGN113404 was conducted at three sites in France and three sites in Germany, with 15 subjects randomized to receive GSK2248761. Therefore, the study population for the current study will consist of 35 subjects originating from sites located in the United States, Romania, France, and Germany.\n\nAll subjects enrolled in this study previously received GSK2248761 in one of the Phase 2b clinical trials SGN113399 or SGN113404 of GSK2248761 for the treatment of HIV. This study will collect clinical and safety data on all subjects. Data from these subjects\' medical charts will be collected from the point of termination of the Phase 2b clinical trials. Any subject who experienced any seizure during the Phase 2b clinical trial will be followed for two years. Subjects who experienced no seizure during the Phase 2b clinical trial will be followed for one year. In the event that a subject who did not previously have a seizure experiences a seizure during the study period, the subject will be moved to the "seizure subject group" that is being followed for two years. Data collection will occur on a quarterly basis for all subjects.\n\nNo formal analyses will be performed. All data collected for each subject will be incorporated into a narrative of the subject\'s medical events during the follow-up period. The narrative will recreate the clinical course and evolution of disease history for the subjects and allow assessment for evidence of residual or new adverse events potentially related to their exposure to GSK2248761. Listings of AEs will be generated for each subject. Data on AEs collected quarterly will be combined with the subject\'s demographic and medical history details in the listing reports. The listings will be delivered to GSK every six months in coordination with the safety advisory committee meetings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All subjects who were previously randomized in the Phase 2b studies SGN113399 or SGN113404 and received GSK2248761 will be targeted for enrollment in the study. Study SGN11339 had 20 subjects randomized to receive GSK2248761 and was conducted at 12 sites in the United States and one site in Romania. Study SGN113404 was conducted at three sites in France and three sites in Germany, with 15 subjects randomized to receive GSK2248761. Therefore, the study population for the current study will consist of 35 subjects originating from sites located in the United States, Romania, France, and Germany.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who were previously randomized in the Phase 2b studies SGN113399 or SGN113404 and received GSK2248761\n\nExclusion Criteria:\n\n* N/A'}, 'identificationModule': {'nctId': 'NCT01458132', 'briefTitle': 'Drug Exposure Registry for GSK2248761, an Investigational NNRTI', 'organization': {'class': 'INDUSTRY', 'fullName': 'ViiV Healthcare'}, 'officialTitle': 'WEUSKOP5522: Observational Drug Exposure Registry for Long-Term Follow-Up of Subjects Exposed to GSK2248761', 'orgStudyIdInfo': {'id': '115682'}, 'secondaryIdInfos': [{'id': 'WEUSKOP5522', 'type': 'OTHER', 'domain': 'GSK'}, {'id': 'EPI40670', 'type': 'OTHER', 'domain': 'GSK'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subjects who experienced seizure', 'description': 'Subjects who were previously randomized in the Phase 2b studies SGN113399 or SGN113404 and experienced seizure'}, {'label': 'Subjects who did not experience seizure', 'description': 'Subjects who were previously randomized in the Phase 2b studies SGN113399 or SGN113404 and did not experience seizure'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ViiV Healthcare'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ViiV Healthcare', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}