Viewing Study NCT00293267

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Ignite Creation Date: 2025-12-25 @ 12:33 AM
Ignite Modification Date: 2025-12-25 @ 10:40 PM
Study NCT ID: NCT00293267
Status: COMPLETED
Last Update Posted: 2015-09-07
First Post: 2006-02-14
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: A Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in HIV-Infected Patients Failing Current Antiretroviral Therapies (MK0518-018 EXT2)
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia', 'Belgium', 'Denmark', 'France', 'Germany', 'Italy', 'Peru', 'Portugal', 'Spain', 'Switzerland', 'Taiwan', 'Thailand']}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068898', 'term': 'Raltegravir Potassium'}], 'ancestors': [{'id': 'D011760', 'term': 'Pyrrolidinones'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp'}, 'certainAgreement': {'otherDetails': 'Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck 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}, 'limitationsAndCaveats': {'description': 'Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.'}}, 'adverseEventsModule': {'timeFrame': '240 Weeks', 'description': 'Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.', 'eventGroups': [{'id': 'EG000', 'title': 'Raltegravir 400 mg b.i.d Plus OBT', 'description': 'Includes all participants initially randomized to raltegravir, including those without virologic failure who\n\ncontinued into the open-label phase at Week 156 and those who entered the OLPVF phase due to virologic failure. During either open-label phase up to Week 240, these participants continued to receive raltegravir 400 mg b.i.d. plus OBT.', 'otherNumAtRisk': 232, 'otherNumAffected': 206, 'seriousNumAtRisk': 232, 'seriousNumAffected': 97}, {'id': 'EG001', 'title': 'Placebo Plus OBT', 'description': 'Includes all participants initially randomized to placebo, including those without virologic failure who continued into the open-label phase at Week 156 and those who entered the OLPVF phase due to virologic failure. During either open-label phase up to Week 240, these participants continued to receive raltegravir 400 mg b.i.d. plus OBT.', 'otherNumAtRisk': 118, 'otherNumAffected': 104, 'seriousNumAtRisk': 118, 'seriousNumAffected': 46}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 13, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 110, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 70, 'numAffected': 34}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 38, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 25, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 26, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 25, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 9, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 19, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 16, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 35, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 23, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Anogenital warts', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 71, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 23, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 28, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Genital herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Herpes simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 23, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 10, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 28, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 11, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 96, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 51, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 20, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 24, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 11, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 21, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 15, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 13, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 35, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 15, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 17, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 40, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 19, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 30, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 18, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Blood cholesterol increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 44, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 20, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Blood triglycerides increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 30, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 14, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 33, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 14, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 15, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 16, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Skin papilloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 20, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 38, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 29, 'numAffected': 24}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 24, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 14, 'numAffected': 12}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 24, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 14, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Lipodystrophy acquired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 20, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 25, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 12, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 32, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Haemolytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Haemolytic uraemic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Splenic vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 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'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hidradenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypovolaemic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Varicophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Raltegravir 400 mg b.i.d. + OBT'}, {'id': 'OG001', 'title': 'Placebo + OBT'}], 'classes': [{'categories': [{'measurements': [{'value': '77.7', 'groupId': 'OG000', 'lowerLimit': '71.8', 'upperLimit': '82.9'}, {'value': '41.0', 'groupId': 'OG001', 'lowerLimit': '32.0', 'upperLimit': '50.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '16 Weeks', 'description': 'Percentage of participants who achieved HIV RNA \\<400 copies/mL at Week 16', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 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'Raltegravir 400 mg b.i.d. + OBT'}, {'id': 'OG001', 'title': 'Placebo + OBT'}], 'classes': [{'categories': [{'measurements': [{'value': '64.5', 'groupId': 'OG000', 'lowerLimit': '58.0', 'upperLimit': '70.7'}, {'value': '31.4', 'groupId': 'OG001', 'lowerLimit': '23.1', 'upperLimit': '40.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '48 Weeks', 'description': 'Percentage of participants who achieved HIV RNA \\<50 copies/mL at Week 48', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.'}, {'type': 'SECONDARY', 'title': 'Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <50 Copies/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Raltegravir 400 mg b.i.d. + OBT'}, {'id': 'OG001', 'title': 'Placebo + OBT'}], 'classes': [{'categories': [{'measurements': [{'value': '53.4', 'groupId': 'OG000', 'lowerLimit': '46.8', 'upperLimit': '60.0'}, {'value': '25.6', 'groupId': 'OG001', 'lowerLimit': '18.0', 'upperLimit': '34.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '156 weeks', 'description': 'Percentage of participants who achieved HIV RNA \\<50 copies/mL at Week 156', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.'}, {'type': 'SECONDARY', 'title': 'Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <50 Copies/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Raltegravir 400 mg b.i.d. + OBT', 'description': 'Raltegravir 400 mg b.i.d plus OBT includes all participants initially randomized to raltegravir. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants continued to receive raltegravir plus OBT until Week 240.'}, {'id': 'OG001', 'title': 'Placebo + OBT', 'description': 'Placebo plus OBT includes all participants initially randomized to placebo. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants received raltegravir plus OBT until Week 240.'}], 'classes': [{'categories': [{'measurements': [{'value': '42.2', 'groupId': 'OG000', 'lowerLimit': '35.8', 'upperLimit': '48.9'}, {'value': '18.6', 'groupId': 'OG001', 'lowerLimit': '12.1', 'upperLimit': '26.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '240 weeks', 'description': 'Percentage of participants who achieved HIV RNA \\<50 copies/mL at Week 240', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Raltegravir 400 mg b.i.d. + OBT'}, {'id': 'OG001', 'title': 'Placebo + OBT'}], 'classes': [{'categories': [{'measurements': [{'value': '73.6', 'groupId': 'OG000', 'lowerLimit': '67.4', 'upperLimit': '79.2'}, {'value': '36.4', 'groupId': 'OG001', 'lowerLimit': '27.8', 'upperLimit': '45.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '48 Weeks', 'description': 'Percentage of participants who achieved HIV RNA \\<400 copies/mL at Week 48', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.'}, {'type': 'SECONDARY', 'title': 'Double-Blind Extension - Week 156: Percentage of Participants Without Loss of Virologic Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Raltegravir 400 mg b.i.d. + OBT'}, {'id': 'OG001', 'title': 'Placebo + OBT'}], 'classes': [{'categories': [{'measurements': [{'value': '47.4', 'groupId': 'OG000'}, {'value': '24.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '156 weeks', 'description': 'For participants with confirmed HIV RNA levels \\<50 copies/mL on 2 consecutive visits, loss of virologic response is the occurrence of the first value \\>50 copies/mL or loss to follow-up; participants who never achieved HIV RNA \\<50 copies/mL on 2 consecutive visits are also considered as having loss of virologic response. Events are the numbers of participants with loss of virologic response versus the numbers of participants with no loss of virologic response (event free).', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HIV RNA (log10 Copies/mL) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Raltegravir 400 mg b.i.d. + OBT'}, {'id': 'OG001', 'title': 'Placebo + OBT'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.85', 'groupId': 'OG000', 'lowerLimit': '-1.97', 'upperLimit': '-1.73'}, {'value': '-0.78', 'groupId': 'OG001', 'lowerLimit': '-0.97', 'upperLimit': '-0.59'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 16', 'description': 'Mean change from baseline at Week 16 in HIV RNA (log10 copies/mL)', 'unitOfMeasure': 'HIV RNA (log10 copies/mL)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Observed mean change from baseline in log10 plasma HIV RNA calculated using conventional imputation (replace \\<400 copies by 400 copies if signal detected; 200 copies if not detected); Missing values: baseline carry-\n\nforward for all failures/discontinued due to lack of efficacy'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HIV RNA (log10 Copies/mL) at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Raltegravir 400 mg b.i.d. + OBT'}, {'id': 'OG001', 'title': 'Placebo + OBT'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.67', 'groupId': 'OG000', 'lowerLimit': '-1.81', 'upperLimit': '-1.54'}, {'value': '-0.68', 'groupId': 'OG001', 'lowerLimit': '-0.86', 'upperLimit': '-0.50'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 48', 'description': 'Mean change from baseline at Week 48 in HIV RNA (log10 copies/mL)', 'unitOfMeasure': 'HIV RNA (log10 copies/mL)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Observed mean change from baseline in log10 plasma HIV RNA calculated using conventional imputation (replace \\<400 copies by 400 copies if signal detected; 200 copies if not detected); Missing values: baseline carry-forward for all failures/discontinued due to lack of efficacy\n\nParticipants with virologic failure after Week 16 = treatment failures'}, {'type': 'SECONDARY', 'title': 'Double-Blind Extension - Week 156: Change From Baseline in HIV RNA (log10 Copies/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Raltegravir 400 mg b.i.d. + OBT'}, {'id': 'OG001', 'title': 'Placebo + OBT'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.44', 'groupId': 'OG000', 'lowerLimit': '-1.60', 'upperLimit': '-1.28'}, {'value': '-0.51', 'groupId': 'OG001', 'lowerLimit': '-0.67', 'upperLimit': '-0.34'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 156', 'description': 'Mean change from baseline at Week 156 in HIV RNA (log10 copies/mL)', 'unitOfMeasure': 'HIV RNA (log10 copies/mL)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Observed mean change from baseline in log10 plasma HIV RNA calculated using conventional imputation (replace \\<400 copies by 400 copies if signal detected; 200 copies if not detected); Missing values: baseline carry-forward for all failures/discontinued due to lack of efficacy\n\nParticipants with virologic failure after Week 16 = treatment failures'}, {'type': 'SECONDARY', 'title': 'Open-Label Extension - Week 240: Change From Baseline in HIV RNA (log10 Copies/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Raltegravir 400 mg b.i.d. + OBT', 'description': 'Raltegravir 400 mg b.i.d plus OBT includes all participants initially randomized to raltegravir. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants continued to receive raltegravir plus OBT until Week 240.'}, {'id': 'OG001', 'title': 'Placebo + OBT', 'description': 'Placebo plus OBT includes all participants initially randomized to placebo. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants received raltegravir plus OBT until Week 240.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.24', 'groupId': 'OG000', 'lowerLimit': '-1.42', 'upperLimit': '-1.07'}, {'value': '-0.45', 'groupId': 'OG001', 'lowerLimit': '-0.62', 'upperLimit': '-0.27'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 240', 'description': 'Mean change from baseline at Week 240 in HIV RNA (log10 copies/mL)', 'unitOfMeasure': 'HIV RNA (log10 copies/mL)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Observed mean change from baseline in log10 plasma HIV RNA calculated using conventional imputation (replace \\<400 copies by 400 copies if signal detected; 200 copies if not detected); Missing values: baseline carry-forward for all failures/discontinued due to lack of efficacy\n\nParticipants with virologic failure after Week 16 = treatment failures'}, {'type': 'PRIMARY', 'title': 'Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <400 Copies/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Raltegravir 400 mg b.i.d. + OBT'}, {'id': 'OG001', 'title': 'Placebo + OBT'}], 'classes': [{'categories': [{'measurements': [{'value': '57.3', 'groupId': 'OG000', 'lowerLimit': '50.7', 'upperLimit': '63.8'}, {'value': '25.6', 'groupId': 'OG001', 'lowerLimit': '18.0', 'upperLimit': '34.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '156 Weeks', 'description': 'Percentage of participants who achieved HIV RNA \\<400 copies/mL at Week 156', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was based on a non-completer equals failure approach where missing values for participants who discontinued the study for any reason were considered treatment failures.\n\nParticipants who experienced virologic failure after Week 16 are counted also as treatment failures for the subsequent virologic efficacy analyses.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Raltegravir 400 mg b.i.d. + OBT'}, {'id': 'OG001', 'title': 'Placebo + OBT'}], 'classes': [{'categories': [{'measurements': [{'value': '82.7', 'groupId': 'OG000', 'lowerLimit': '70.5', 'upperLimit': '94.9'}, {'value': '31.3', 'groupId': 'OG001', 'lowerLimit': '17.8', 'upperLimit': '44.8'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 16', 'description': 'Mean change from baseline at Week 16 in CD4 Cell Count (cells/mm\\^3)', 'unitOfMeasure': 'CD4 Cell Count (cells/mm^3)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm\\^3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Raltegravir 400 mg b.i.d. + OBT'}, {'id': 'OG001', 'title': 'Placebo + OBT'}], 'classes': [{'categories': [{'measurements': [{'value': '120.2', 'groupId': 'OG000', 'lowerLimit': '102.2', 'upperLimit': '138.1'}, {'value': '49.4', 'groupId': 'OG001', 'lowerLimit': '30.4', 'upperLimit': '68.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 48', 'description': 'Mean change from baseline at Week 48 in CD4 Cell Count (cells/mm\\^3)', 'unitOfMeasure': 'CD4 Cell Count (cells/mm^3)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm\\^3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.\n\nParticipants with virologic failure after Week 16 are treatment failures for virologic efficacy analyses.'}, {'type': 'PRIMARY', 'title': 'Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <400 Copies/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Raltegravir 400 mg b.i.d. + OBT', 'description': 'Raltegravir 400 mg b.i.d plus OBT includes all participants initially randomized to raltegravir. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants continued to receive raltegravir plus OBT until Week 240.'}, {'id': 'OG001', 'title': 'Placebo + OBT', 'description': 'Placebo plus OBT includes all participants initially randomized to placebo. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants received raltegravir plus OBT until Week 240.'}], 'classes': [{'categories': [{'measurements': [{'value': '45.3', 'groupId': 'OG000', 'lowerLimit': '38.7', 'upperLimit': '51.9'}, {'value': '20.3', 'groupId': 'OG001', 'lowerLimit': '13.5', 'upperLimit': '28.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '240 Weeks', 'description': 'Percentage of participants who achieved HIV RNA \\<400 Copies/mL at Week 240', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was based on a non-completer equals failure approach where missing values for participants who discontinued the study for any reason were considered treatment failures.\n\nParticipants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.'}, {'type': 'SECONDARY', 'title': 'Double-Blind Extension - Week 156: Change From Baseline in CD4 Cell Count (Cells/mm^3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Raltegravir 400 mg b.i.d. + OBT'}, {'id': 'OG001', 'title': 'Placebo + OBT'}], 'classes': [{'categories': [{'measurements': [{'value': '170.9', 'groupId': 'OG000', 'lowerLimit': '144.4', 'upperLimit': '197.4'}, {'value': '71.03', 'groupId': 'OG001', 'lowerLimit': '46.28', 'upperLimit': '95.77'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 156', 'description': 'Mean change from baseline at Week 156 in CD4 Cell Count (cells/mm\\^3)', 'unitOfMeasure': 'CD4 Cell Count (cells/mm^3)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm\\^3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.\n\nParticipants with virologic failure after Week 16 are treatment failures for virologic efficacy analyses.'}, {'type': 'SECONDARY', 'title': 'Open-Label Extension - Week 240: Change From Baseline in CD4 Cell Count (Cells/mm^3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Raltegravir 400 mg b.i.d. + OBT', 'description': 'Raltegravir 400 mg b.i.d plus OBT includes all participants initially randomized to raltegravir. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants continued to receive raltegravir plus OBT until Week 240.'}, {'id': 'OG001', 'title': 'Placebo + OBT', 'description': 'Placebo plus OBT includes all participants initially randomized to placebo. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants received raltegravir plus OBT until Week 240.'}], 'classes': [{'categories': [{'measurements': [{'value': '193.6', 'groupId': 'OG000', 'lowerLimit': '159.1', 'upperLimit': '228.0'}, {'value': '68.2', 'groupId': 'OG001', 'lowerLimit': '38.2', 'upperLimit': '98.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 240', 'description': 'Mean change from baseline at Week 240 in CD4 Cell Count (cells/mm\\^3)', 'unitOfMeasure': 'CD4 Cell Count (cells/mm^3)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm\\^3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.\n\nParticipants with virologic failure after Week 16 are treatment failures for virologic efficacy analyses.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Raltegravir 400 mg b.i.d. + OBT'}, {'id': 'FG001', 'title': 'Placebo + OBT'}], 'periods': [{'title': 'Primary Study - Double-Blind Week 0-48', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '234'}, {'groupId': 'FG001', 'numSubjects': '118'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '232'}, {'groupId': 'FG001', 'numSubjects': '118'}]}, {'type': 'Continuing in Double-Blind', 'achievements': [{'comment': 'Excludes participants who entered the open-label post virological failure (OLPVF) phase', 'groupId': 'FG000', 'numSubjects': '193'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '193'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '68'}]}], 'dropWithdraws': [{'type': 'Never Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Entered OLPVF Phase', 'reasons': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '60'}]}]}, {'title': 'Extension - Double-Blind Week 49-156', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '2 participants who completed Week 48 did not enter the extension study', 'groupId': 'FG000', 'numSubjects': '191'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '139'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Participant relocated or site terminated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Entered OLPVF Phase', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}, {'title': 'Extension - Open-Label Week 157-240', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '8 of 139 participants who completed the double-blind phase did not enter this open-label phase', 'groupId': 'FG000', 'numSubjects': '131'}, {'comment': '7 of 35 participants who completed the double-blind phase did not enter this open-label phase', 'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '111'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Participant relocated or site terminated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Open-Label Post Virologic Failure Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Number of participants who failed treatment and consented to enter the OLPVF phase', 'groupId': 'FG000', 'numSubjects': '48'}, {'comment': 'Number of participants who failed treatment and consented to enter the OLPVF phase', 'groupId': 'FG001', 'numSubjects': '66'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '37'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Laboratory Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Participant Moved or Site Terminated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Other Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'Phase 3; First Patient In: Mar 2006; Last Patient Last Visit (LPLV) Week 48: Aug 2007; 61 of 63 sites in Australia, Belgium, Denmark, France, Germany, Italy, Peru, Portugal, Spain, Switzerland, Taiwan, Thailand randomized patients. Extension Study LPLV Week 240: June 2011', 'preAssignmentDetails': 'Patients failed prior antiretroviral therapy (HIV RNA \\>1000 copies/mL), and had documented resistance to at least one drug in each class of licensed oral antiretroviral therapy (Nucleoside Reverse Transcriptase inhibitors, Non-Nucleoside Reverse Transcriptase inhibitors and Protease Inhibitors). All patients must have met laboratory criteria.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '350', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Raltegravir 400 mg b.i.d. + OBT'}, {'id': 'BG001', 'title': 'Placebo + OBT'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.1', 'groupId': 'BG000', 'lowerLimit': '16', 'upperLimit': '74'}, {'value': '43.7', 'groupId': 'BG001', 'lowerLimit': '19', 'upperLimit': '64'}, {'value': '45.3', 'groupId': 'BG002', 'lowerLimit': '16', 'upperLimit': '74'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '195', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '298', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '174', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '270', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Cluster of Differentiation 4 (CD4) Cell Count', 'classes': [{'categories': [{'measurements': [{'value': '156', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '792'}, {'value': '153', 'groupId': 'BG001', 'lowerLimit': '3', 'upperLimit': '759'}, {'value': '155', 'groupId': 'BG002', 'lowerLimit': '1', 'upperLimit': '792'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'FULL_RANGE'}, {'title': 'Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA)', 'classes': [{'categories': [{'measurements': [{'value': '40519', 'groupId': 'BG000', 'lowerLimit': '441', 'upperLimit': '750000'}, {'value': '31828', 'groupId': 'BG001', 'lowerLimit': '200', 'upperLimit': '750000'}, {'value': '37352', 'groupId': 'BG002', 'lowerLimit': '200', 'upperLimit': '750000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'unitOfMeasure': 'copies/mL', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 352}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-04', 'studyFirstSubmitDate': '2006-02-14', 'resultsFirstSubmitDate': '2009-08-18', 'studyFirstSubmitQcDate': '2006-02-15', 'lastUpdatePostDateStruct': {'date': '2015-09-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-09-25', 'studyFirstPostDateStruct': {'date': '2006-02-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 16', 'timeFrame': '16 Weeks', 'description': 'Percentage of participants who achieved HIV RNA \\<400 copies/mL at Week 16'}, {'measure': 'Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 48', 'timeFrame': '48 Weeks', 'description': 'Percentage of participants who achieved HIV RNA \\<400 copies/mL at Week 48'}, {'measure': 'Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <400 Copies/mL', 'timeFrame': '156 Weeks', 'description': 'Percentage of participants who achieved HIV RNA \\<400 copies/mL at Week 156'}, {'measure': 'Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <400 Copies/mL', 'timeFrame': '240 Weeks', 'description': 'Percentage of participants who achieved HIV RNA \\<400 Copies/mL at Week 240'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 16', 'timeFrame': '16 Weeks', 'description': 'Percentage of participants who achieved HIV RNA \\<50 copies/mL at Week 16'}, {'measure': 'Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 48', 'timeFrame': '48 Weeks', 'description': 'Percentage of participants who achieved HIV RNA \\<50 copies/mL at Week 48'}, {'measure': 'Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <50 Copies/mL', 'timeFrame': '156 weeks', 'description': 'Percentage of participants who achieved HIV RNA \\<50 copies/mL at Week 156'}, {'measure': 'Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <50 Copies/mL', 'timeFrame': '240 weeks', 'description': 'Percentage of participants who achieved HIV RNA \\<50 copies/mL at Week 240'}, {'measure': 'Double-Blind Extension - Week 156: Percentage of Participants Without Loss of Virologic Response', 'timeFrame': '156 weeks', 'description': 'For participants with confirmed HIV RNA levels \\<50 copies/mL on 2 consecutive visits, loss of virologic response is the occurrence of the first value \\>50 copies/mL or loss to follow-up; participants who never achieved HIV RNA \\<50 copies/mL on 2 consecutive visits are also considered as having loss of virologic response. Events are the numbers of participants with loss of virologic response versus the numbers of participants with no loss of virologic response (event free).'}, {'measure': 'Change From Baseline in HIV RNA (log10 Copies/mL) at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'Mean change from baseline at Week 16 in HIV RNA (log10 copies/mL)'}, {'measure': 'Change From Baseline in HIV RNA (log10 Copies/mL) at Week 48', 'timeFrame': 'Baseline and Week 48', 'description': 'Mean change from baseline at Week 48 in HIV RNA (log10 copies/mL)'}, {'measure': 'Double-Blind Extension - Week 156: Change From Baseline in HIV RNA (log10 Copies/mL)', 'timeFrame': 'Baseline and Week 156', 'description': 'Mean change from baseline at Week 156 in HIV RNA (log10 copies/mL)'}, {'measure': 'Open-Label Extension - Week 240: Change From Baseline in HIV RNA (log10 Copies/mL)', 'timeFrame': 'Baseline and Week 240', 'description': 'Mean change from baseline at Week 240 in HIV RNA (log10 copies/mL)'}, {'measure': 'Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'Mean change from baseline at Week 16 in CD4 Cell Count (cells/mm\\^3)'}, {'measure': 'Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 48', 'timeFrame': 'Baseline and Week 48', 'description': 'Mean change from baseline at Week 48 in CD4 Cell Count (cells/mm\\^3)'}, {'measure': 'Double-Blind Extension - Week 156: Change From Baseline in CD4 Cell Count (Cells/mm^3)', 'timeFrame': 'Baseline and Week 156', 'description': 'Mean change from baseline at Week 156 in CD4 Cell Count (cells/mm\\^3)'}, {'measure': 'Open-Label Extension - Week 240: Change From Baseline in CD4 Cell Count (Cells/mm^3)', 'timeFrame': 'Baseline and Week 240', 'description': 'Mean change from baseline at Week 240 in CD4 Cell Count (cells/mm\\^3)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Treatment Experienced'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '18650512', 'type': 'BACKGROUND', 'citation': 'Steigbigel RT, Cooper DA, Kumar PN, Eron JE, Schechter M, Markowitz M, Loutfy MR, Lennox JL, Gatell JM, Rockstroh JK, Katlama C, Yeni P, Lazzarin A, Clotet B, Zhao J, Chen J, Ryan DM, Rhodes RR, Killar JA, Gilde LR, Strohmaier KM, Meibohm AR, Miller MD, Hazuda DJ, Nessly ML, DiNubile MJ, Isaacs RD, Nguyen BY, Teppler H; BENCHMRK Study Teams. Raltegravir with optimized background therapy for resistant HIV-1 infection. N Engl J Med. 2008 Jul 24;359(4):339-54. doi: 10.1056/NEJMoa0708975.'}, {'pmid': '18650513', 'type': 'BACKGROUND', 'citation': 'Cooper DA, Steigbigel RT, Gatell JM, Rockstroh JK, Katlama C, Yeni P, Lazzarin A, Clotet B, Kumar PN, Eron JE, Schechter M, Markowitz M, Loutfy MR, Lennox JL, Zhao J, Chen J, Ryan DM, Rhodes RR, Killar JA, Gilde LR, Strohmaier KM, Meibohm AR, Miller MD, Hazuda DJ, Nessly ML, DiNubile MJ, Isaacs RD, Teppler H, Nguyen BY; BENCHMRK Study Teams. Subgroup and resistance analyses of raltegravir for resistant HIV-1 infection. N Engl J Med. 2008 Jul 24;359(4):355-65. doi: 10.1056/NEJMoa0708978.'}, {'pmid': '20085491', 'type': 'RESULT', 'citation': 'Steigbigel RT, Cooper DA, Teppler H, Eron JJ, Gatell JM, Kumar PN, Rockstroh JK, Schechter M, Katlama C, Markowitz M, Yeni P, Loutfy MR, Lazzarin A, Lennox JL, Clotet B, Zhao J, Wan H, Rhodes RR, Strohmaier KM, Barnard RJ, Isaacs RD, Nguyen BY; BENCHMRK Study Teamsa. Long-term efficacy and safety of Raltegravir combined with optimized background therapy in treatment-experienced patients with drug-resistant HIV infection: week 96 results of the BENCHMRK 1 and 2 Phase III trials. Clin Infect Dis. 2010 Feb 15;50(4):605-12. doi: 10.1086/650002.'}]}, 'descriptionModule': {'briefSummary': 'This study will investigate the safety and efficacy of raltegravir as a therapy for HIV-infected patients failing current therapy with 3-class antiviral resistance.', 'detailedDescription': 'The primary double-blind study of raltegravir versus placebo was extended to 156 weeks and was followed by an open-label raltegravir phase in which continuing participants from both the raltegravir and placebo groups received open-label raltegravir for an additional 84 weeks for a maximum duration of up to 240 weeks. Participants who had viral failure after Week 16 may have received open-label raltegravir until Week 240.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient must be HIV positive with HIV RNA values that are within ranges required by the study\n* Patient must have documented failure of certain antiretroviral therapy\n* Patient must be on the same antiretroviral therapy for at least the past two months\n\nExclusion Criteria:\n\n* Patient is less than 16 years old\n* Additional study criteria will be discussed and identified by the study doctor'}, 'identificationModule': {'nctId': 'NCT00293267', 'briefTitle': 'A Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in HIV-Infected Patients Failing Current Antiretroviral Therapies (MK0518-018 EXT2)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 in Combination With an Optimized Background Therapy (OBT), Versus Optimized Background Therapy Alone, in HIV-Infected Patients With Documented Resistance to at Least 1 Drug in Each of the 3 Classes of Licensed Oral Antiviral Therapies', 'orgStudyIdInfo': {'id': '0518-018'}, 'secondaryIdInfos': [{'id': '2005_096'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'raltegravir potassium', 'interventionNames': ['Drug: raltegravir potassium']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Placebo', 'interventionNames': ['Drug: Comparator: Placebo']}], 'interventions': [{'name': 'raltegravir potassium', 'type': 'DRUG', 'otherNames': ['ISENTRESS™'], 'description': 'Raltegravir 400 mg twice daily (b.i.d.) by mouth (p.o.) with optimized background therapy. Treatment period of 48 weeks.', 'armGroupLabels': ['1']}, {'name': 'Comparator: Placebo', 'type': 'DRUG', 'description': 'Placebo b.i.d. p.o. with optimized background therapy. Treatment period of 48 weeks.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}