Ignite Creation Date:
2025-12-24 @ 7:14 PM
Ignite Modification Date:
2025-12-29 @ 10:40 AM
Study NCT ID:
NCT00443703
Status:
TERMINATED
Last Update Posted:
2017-03-21
First Post:
2007-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
MK0518 in the Treatment of HIV-Infected Patients Switched From a Protease Inhibitor Regimen (0518-032)(TERMINATED)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia', 'Canada', 'Denmark', 'Germany', 'Italy', 'Portugal', 'Spain', 'United Kingdom', 'United States']}, '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'}, {'id': 'D061466', 'term': 'Lopinavir'}, {'id': 'D019438', 'term': 'Ritonavir'}, {'id': 'C558899', 'term': 'lopinavir-ritonavir drug combination'}], 'ancestors': [{'id': 'D011760', 'term': 'Pyrrolidinones'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'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': 'The reason for early termination: Study was terminated after the primary efficacy analysis at Week 24 did not demonstrate non-inferiority of MK0518 versus KALETRA™.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.', 'description': 'The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.', 'eventGroups': [{'id': 'EG000', 'title': 'MK0518 400 mg b.i.d.', 'description': 'MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food', 'otherNumAtRisk': 174, 'otherNumAffected': 76, 'seriousNumAtRisk': 174, 'seriousNumAffected': 15}, {'id': 'EG001', 'title': 'KALETRA™ 400/100 mg b.i.d.', 'description': 'KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food', 'otherNumAtRisk': 174, 'otherNumAffected': 77, 'seriousNumAtRisk': 174, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Syphilis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': "Basedow's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ulcerative keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Foreign body trauma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebrospinal fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lumbar radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute stress disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bipolar I disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Epididymitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vasodilatation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients With Plasma Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) <50 Copies/mL at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MK0518 400 mg b.i.d.', 'description': 'MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food'}, {'id': 'OG001', 'title': 'KALETRA™ 400/100 mg b.i.d.', 'description': 'KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food'}], 'classes': [{'categories': [{'measurements': [{'value': '139', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set; two patients were excluded from the analysis because they did not have an HIV RNA test performed at Week 24 but had a test result of HIV RNA \\<50 copies/mL at Week 12 and Week 36.'}, {'type': 'PRIMARY', 'title': 'Number of Patients With Clinical Adverse Experiences (CAEs) Through 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MK0518 400 mg b.i.d.', 'description': 'MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food'}, {'id': 'OG001', 'title': 'KALETRA™ 400/100 mg b.i.d.', 'description': 'KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food'}], 'classes': [{'title': 'With CAEs', 'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}]}, {'title': 'Without CAEs', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 Week last patient last visit', 'description': "An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S (Merck \\& Co., Inc.) product, whether or not considered related to the use of the product", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who took study medication were included in the analysis'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Patients With Serious CAEs Through 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MK0518 400 mg b.i.d.', 'description': 'MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food'}, {'id': 'OG001', 'title': 'KALETRA™ 400/100 mg b.i.d.', 'description': 'KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food'}], 'classes': [{'title': 'With Serious CAEs', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Without Serious CAEs', 'categories': [{'measurements': [{'value': '159', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 Week last patient last visit', 'description': 'Serious CAEs are any AEs occurring at any dose that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who took study medication were included in the analysis'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Patients With Drug-related CAEs Through 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MK0518 400 mg b.i.d.', 'description': 'MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food'}, {'id': 'OG001', 'title': 'KALETRA™ 400/100 mg b.i.d.', 'description': 'KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food'}], 'classes': [{'title': 'With drug-related CAEs', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Without drug-related CAEs', 'categories': [{'measurements': [{'value': '150', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 Week last patient last visit', 'description': 'Patients with drug-related (as assessed by an investigator who is a qualified physician, according to his/her best clinical judgement) CAEs.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who took study medication were included in the analysis'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Patients With Serious Drug-related CAEs Through 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MK0518 400 mg b.i.d.', 'description': 'MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food'}, {'id': 'OG001', 'title': 'KALETRA™ 400/100 mg b.i.d.', 'description': 'KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food'}], 'classes': [{'title': 'With Serious drug-related CAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Without Serious drug-related CAEs', 'categories': [{'measurements': [{'value': '174', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 Week last patient last visit', 'description': 'Serious CAEs are any AEs occurring at any dose that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. Drug-related are as assessed by an investigator who is a qualified physician, according to his/her best clinical judgement', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who took study medication were included in the analysis'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Patients That Died by 24 Week Last Patient Last Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MK0518 400 mg b.i.d.', 'description': 'MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food'}, {'id': 'OG001', 'title': 'KALETRA™ 400/100 mg b.i.d.', 'description': 'KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food'}], 'classes': [{'title': 'Died', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Did Not Die', 'categories': [{'measurements': [{'value': '174', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 Week last patient last visit', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who took study medication were included in the analysis'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Patients That Discontinued Due to CAEs Through 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MK0518 400 mg b.i.d.', 'description': 'MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food'}, {'id': 'OG001', 'title': 'KALETRA™ 400/100 mg b.i.d.', 'description': 'KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food'}], 'classes': [{'title': 'Discontinued with CAEs', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Did not Discontinue with CAEs', 'categories': [{'measurements': [{'value': '170', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 Week last patient last visit', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who took study medication were included in the analysis'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Patients That Discontinued Due to Drug Related CAEs Through 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MK0518 400 mg b.i.d.', 'description': 'MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food'}, {'id': 'OG001', 'title': 'KALETRA™ 400/100 mg b.i.d.', 'description': 'KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food'}], 'classes': [{'title': 'Discontinued with drug related CAEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Did Not Discontinue with drug related CAEs', 'categories': [{'measurements': [{'value': '172', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 Week last patient last visit', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who took study medication were included in the analysis'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Patients With Laboratory Adverse Experiences (LAEs) Through 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MK0518 400 mg b.i.d.', 'description': 'MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food'}, {'id': 'OG001', 'title': 'KALETRA™ 400/100 mg b.i.d.', 'description': 'KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food'}], 'classes': [{'title': 'With LAEs', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Without LAEs', 'categories': [{'measurements': [{'value': '163', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 Week last patient last visit', 'description': "A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S (Merck \\& Co., Inc.) product, whether or not considered related to the use of the product", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who took study medication were included in the analysis'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) Through 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MK0518 400 mg b.i.d.', 'description': 'MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food'}, {'id': 'OG001', 'title': 'KALETRA™ 400/100 mg b.i.d.', 'description': 'KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food'}], 'classes': [{'title': 'With LAEs', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Without LAEs', 'categories': [{'measurements': [{'value': '168', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 Week last patient last 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400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food'}], 'classes': [{'title': 'With LAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Without LAEs', 'categories': [{'measurements': [{'value': '174', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 Week last patient last visit', 'description': 'Serious LAEs are any LAEs occurring at any dose that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who took study medication were included in the analysis'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Patients That Discontinued Due to LAEs Through 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MK0518 400 mg b.i.d.', 'description': 'MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food'}, {'id': 'OG001', 'title': 'KALETRA™ 400/100 mg b.i.d.', 'description': 'KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food'}], 'classes': [{'title': 'Discontinued with LAEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Did Not Discontinue with LAEs', 'categories': [{'measurements': [{'value': '172', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 Week last patient last visit', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who took study medication were included in the analysis'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Patients That Discontinued With Drug Related LAEs Through 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MK0518 400 mg b.i.d.', 'description': 'MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food'}, {'id': 'OG001', 'title': 'KALETRA™ 400/100 mg b.i.d.', 'description': 'KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food'}], 'classes': [{'title': 'Discontinued with Drug Related LAEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Did Not Discontinue with Drug Related LAEs', 'categories': [{'measurements': [{'value': '172', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 Week last patient last visit', 'description': 'Number of patients that discontinued with drug-related (as assessed by an investigator who is a qualified physician, according to his or her clinical judgement) LAEs.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who took study medication were included in the analysis'}, {'type': 'PRIMARY', 'title': 'Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MK0518 400 mg b.i.d.', 'description': 'MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food'}, {'id': 'OG001', 'title': 'KALETRA™ 400/100 mg b.i.d.', 'description': 'KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.83', 'spread': '12.19', 'groupId': 'OG000'}, {'value': '0.70', 'spread': '14.69', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who had both baseline and at least one post-baseline measurement were included in the analysis'}, {'type': 'PRIMARY', 'title': 'Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MK0518 400 mg b.i.d.', 'description': 'MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food'}, {'id': 'OG001', 'title': 'KALETRA™ 400/100 mg b.i.d.', 'description': 'KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food'}], 'classes': [{'categories': [{'measurements': [{'value': '-15.17', 'spread': '15.80', 'groupId': 'OG000'}, {'value': '2.31', 'spread': '19.37', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who had both baseline and at least one post-baseline measurement were included in the analysis'}, {'type': 'PRIMARY', 'title': 'Mean Percent Change From Baseline in Fasting Serum Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MK0518 400 mg b.i.d.', 'description': 'MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food'}, {'id': 'OG001', 'title': 'KALETRA™ 400/100 mg b.i.d.', 'description': 'KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.43', 'spread': '22.63', 'groupId': 'OG000'}, {'value': '2.05', 'spread': '29.87', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who had both baseline and at least one post-baseline measurement were included in the analysis'}, {'type': 'PRIMARY', 'title': 'Mean Percent Change From Baseline in Fasting Serum High-Density Lipoprotein Cholesterol (HDL-C) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MK0518 400 mg b.i.d.', 'description': 'MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food'}, {'id': 'OG001', 'title': 'KALETRA™ 400/100 mg b.i.d.', 'description': 'KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.86', 'spread': '18.71', 'groupId': 'OG000'}, {'value': '0.78', 'spread': '25.38', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who had both baseline and at least one post-baseline measurement were included in the analysis'}, {'type': 'PRIMARY', 'title': 'Median Percent Change From Baseline in Serum Triglyceride at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MK0518 400 mg b.i.d.', 'description': 'MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food'}, {'id': 'OG001', 'title': 'KALETRA™ 400/100 mg b.i.d.', 'description': 'KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food'}], 'classes': [{'categories': [{'measurements': [{'value': '-41.50', 'spread': '35.37', 'groupId': 'OG000'}, {'value': '3.56', 'spread': '59.36', 'groupId': 'OG001'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Week 12', 'description': 'Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile.', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who had both baseline and at least one post-baseline measurement were included in the analysis'}, {'type': 'SECONDARY', 'title': 'Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MK0518 400 mg b.i.d.', 'description': 'MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food'}, {'id': 'OG001', 'title': 'KALETRA™ 400/100 mg b.i.d.', 'description': 'KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food'}], 'classes': [{'categories': [{'measurements': [{'value': '-13.81', 'spread': '12.02', 'groupId': 'OG000'}, {'value': '2.70', 'spread': '17.69', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who had both baseline and at least one post-baseline measurement were included in the analysis'}, {'type': 'SECONDARY', 'title': 'Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MK0518 400 mg b.i.d.', 'description': 'MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food'}, {'id': 'OG001', 'title': 'KALETRA™ 400/100 mg b.i.d.', 'description': 'KALETRA™ 400/100 mg, 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'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MK0518 400 mg b.i.d.', 'description': 'MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food'}, {'id': 'OG001', 'title': 'KALETRA™ 400/100 mg b.i.d.', 'description': 'KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.12', 'spread': '23.66', 'groupId': 'OG000'}, {'value': '8.54', 'spread': '27.44', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who had both baseline and at least one post-baseline measurement were included in the analysis'}, {'type': 'SECONDARY', 'title': 'Mean Percent Change From Baseline in Fasting Serum High-Density Lipoprotein Cholesterol (HDL-C) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MK0518 400 mg b.i.d.', 'description': 'MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food'}, {'id': 'OG001', 'title': 'KALETRA™ 400/100 mg b.i.d.', 'description': 'KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.42', 'spread': '17.80', 'groupId': 'OG000'}, {'value': '-1.70', 'spread': '20.24', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who had both baseline and at least one post-baseline measurement were included in the analysis'}, {'type': 'SECONDARY', 'title': 'Median Percent Change From Baseline in Serum Triglyceride at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MK0518 400 mg b.i.d.', 'description': 'MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food'}, {'id': 'OG001', 'title': 'KALETRA™ 400/100 mg b.i.d.', 'description': 'KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food'}], 'classes': [{'categories': [{'measurements': [{'value': '-44.53', 'spread': '31.43', 'groupId': 'OG000'}, {'value': '6.14', 'spread': '57.80', 'groupId': 'OG001'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Week 24', 'description': 'Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile.', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who had both baseline and at least one post-baseline measurement were included in the analysis'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MK0518 400 mg b.i.d.', 'description': 'MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food'}, {'id': 'FG001', 'title': 'KALETRA™ 400/100 mg b.i.d.', 'description': 'KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '177'}, {'groupId': 'FG001', 'numSubjects': '175'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '174'}, {'groupId': 'FG001', 'numSubjects': '174'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '149'}, {'groupId': 'FG001', 'numSubjects': '157'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '18'}]}], 'dropWithdraws': [{'type': 'Never Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Phase III; First Patient In: 20-Jun-2007; Last Patient Last Visit for Week 24 (primary endpoint): 31-Oct-2008\n\n47 Sites (US, Canada, Denmark, Germany, Italy, Portugal, Spain, United Kingdom, and Australia).', 'preAssignmentDetails': 'HIV-seropositive patients who were ≥18 years old, had documented HIV RNA \\<50 copies/mL for at least 3 months, had been on a KALETRA™-based regimen for at least 3 months without a change in background antiretroviral therapy, and had no documentation of HIV RNA \\>50 copies/mL for at least 3 months.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'BG000'}, {'value': '174', 'groupId': 'BG001'}, {'value': '348', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'MK0518 400 mg b.i.d.', 'description': 'MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food'}, {'id': 'BG001', 'title': 'KALETRA™ 400/100 mg b.i.d.', 'description': 'KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.4', 'groupId': 'BG000', 'lowerLimit': '23', 'upperLimit': '70'}, {'value': '43.6', 'groupId': 'BG001', 'lowerLimit': '24', 'upperLimit': '71'}, {'value': '44.0', 'groupId': 'BG002', 'lowerLimit': '23', 'upperLimit': '71'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '146', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '275', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '149', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '146', 'groupId': 'BG000'}, {'value': '141', 'groupId': 'BG001'}, {'value': '287', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cluster of Differentiation 4 (CD4) Cell Count', 'classes': [{'categories': [{'measurements': [{'value': '477.6', 'groupId': 'BG000', 'lowerLimit': '65', 'upperLimit': '1446'}, {'value': '508.2', 'groupId': 'BG001', 'lowerLimit': '87', 'upperLimit': '1510'}, {'value': '492.9', 'groupId': 'BG002', 'lowerLimit': '65', 'upperLimit': '1510'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cells/mm3', 'dispersionType': 'FULL_RANGE'}, {'title': 'Fasting (non-random) serum High Density Lipoprotein-Cholesterol (HDL-C)', 'classes': [{'categories': [{'measurements': [{'value': '48.8', 'spread': '16.4', 'groupId': 'BG000'}, {'value': '47.1', 'spread': '14.0', 'groupId': 'BG001'}, {'value': '47.9', 'spread': '15.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting (non-random) serum Low Density Lipoprotein-Cholesterol (LDL-C)', 'classes': [{'categories': [{'measurements': [{'value': '115.3', 'spread': '40.3', 'groupId': 'BG000'}, {'value': '104.8', 'spread': '35.9', 'groupId': 'BG001'}, {'value': '110.0', 'spread': '38.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting (non-random) serum cholesterol', 'classes': [{'categories': [{'measurements': [{'value': '215.3', 'spread': '48.2', 'groupId': 'BG000'}, {'value': '203.9', 'spread': '52.3', 'groupId': 'BG001'}, {'value': '209.6', 'spread': '50.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting (non-random) serum triglyceride', 'classes': [{'categories': [{'measurements': [{'value': '189.5', 'spread': '134.0', 'groupId': 'BG000'}, {'value': '162.0', 'spread': '112.6', 'groupId': 'BG001'}, {'value': '175.0', 'spread': '126.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Non-HDL-C', 'classes': [{'categories': [{'measurements': [{'value': '165.5', 'spread': '48.5', 'groupId': 'BG000'}, {'value': '156.8', 'spread': '53.0', 'groupId': 'BG001'}, {'value': '161.1', 'spread': '50.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}]}}, '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': {'whyStopped': 'primary efficacy analysis at Week 24 did not demonstrate non-inferiority of raltegravir versus lopinavir (+) ritonavir', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-14', 'studyFirstSubmitDate': '2007-03-02', 'resultsFirstSubmitDate': '2009-10-16', 'studyFirstSubmitQcDate': '2007-03-05', 'lastUpdatePostDateStruct': {'date': '2017-03-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-10-16', 'studyFirstPostDateStruct': {'date': '2007-03-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Patients With Serious CAEs Through 24 Weeks', 'timeFrame': '24 Week last patient last visit', 'description': 'Serious CAEs are any AEs occurring at any dose that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose'}, {'measure': 'Number of Patients With Drug-related CAEs Through 24 Weeks', 'timeFrame': '24 Week last patient last visit', 'description': 'Patients with drug-related (as assessed by an investigator who is a qualified physician, according to his/her best clinical judgement) CAEs.'}, {'measure': 'Number of Patients With Serious Drug-related CAEs Through 24 Weeks', 'timeFrame': '24 Week last patient last visit', 'description': 'Serious CAEs are any AEs occurring at any dose that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. Drug-related are as assessed by an investigator who is a qualified physician, according to his/her best clinical judgement'}, {'measure': 'Number of Patients That Died by 24 Week Last Patient Last Visit', 'timeFrame': '24 Week last patient last visit'}, {'measure': 'Number of Patients That Discontinued Due to CAEs Through 24 Weeks', 'timeFrame': '24 Week last patient last visit'}, {'measure': 'Number of Patients That Discontinued Due to Drug Related CAEs Through 24 Weeks', 'timeFrame': '24 Week last patient last visit'}, {'measure': 'Number of Patients With Laboratory Adverse Experiences (LAEs) Through 24 Weeks', 'timeFrame': '24 Week last patient last visit', 'description': "A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S (Merck \\& Co., Inc.) product, whether or not considered related to the use of the product"}, {'measure': 'Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) Through 24 Weeks', 'timeFrame': '24 Week last patient last visit', 'description': 'Patients with drug-related (as assessed by an investigator who is a qualified physician, according to his/her best clinical judgement) LAEs'}, {'measure': 'Number of Patients With Serious LAEs Through 24 Weeks', 'timeFrame': '24 Week last patient last visit', 'description': 'Serious LAEs are any LAEs occurring at any dose that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose'}, {'measure': 'Number of Patients That Discontinued Due to LAEs Through 24 Weeks', 'timeFrame': '24 Week last patient last visit'}, {'measure': 'Number of Patients That Discontinued With Drug Related LAEs Through 24 Weeks', 'timeFrame': '24 Week last patient last visit', 'description': 'Number of patients that discontinued with drug-related (as assessed by an investigator who is a qualified physician, according to his or her clinical judgement) LAEs.'}], 'primaryOutcomes': [{'measure': 'Number of Patients With Plasma Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) <50 Copies/mL at Week 24', 'timeFrame': 'Week 24'}, {'measure': 'Number of Patients With Clinical Adverse Experiences (CAEs) Through 24 Weeks', 'timeFrame': '24 Week last patient last visit', 'description': "An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S (Merck \\& Co., Inc.) product, whether or not considered related to the use of the product"}, {'measure': 'Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 12', 'timeFrame': 'Baseline and Week 12'}, {'measure': 'Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12', 'timeFrame': 'Baseline and Week 12'}, {'measure': 'Mean Percent Change From Baseline in Fasting Serum Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12', 'timeFrame': 'Baseline and Week 12'}, {'measure': 'Mean Percent Change From Baseline in Fasting Serum High-Density Lipoprotein Cholesterol (HDL-C) at Week 12', 'timeFrame': 'Baseline and Week 12'}, {'measure': 'Median Percent Change From Baseline in Serum Triglyceride at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': 'Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile.'}], 'secondaryOutcomes': [{'measure': 'Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 24', 'timeFrame': 'Baseline and Week 24'}, {'measure': 'Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24', 'timeFrame': 'Baseline and Week 24'}, {'measure': 'Mean Percent Change From Baseline in Fasting Serum Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24', 'timeFrame': 'Baseline and Week 24'}, {'measure': 'Mean Percent Change From Baseline in Fasting Serum High-Density Lipoprotein Cholesterol (HDL-C) at Week 24', 'timeFrame': 'Baseline and Week 24'}, {'measure': 'Median Percent Change From Baseline in Serum Triglyceride at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile.'}]}, 'conditionsModule': {'keywords': ['treatment experienced'], 'conditions': ['HIV Infection']}, 'referencesModule': {'references': [{'pmid': '20074791', 'type': 'DERIVED', 'citation': 'Eron JJ, Young B, Cooper DA, Youle M, Dejesus E, Andrade-Villanueva J, Workman C, Zajdenverg R, Fatkenheuer G, Berger DS, Kumar PN, Rodgers AJ, Shaughnessy MA, Walker ML, Barnard RJ, Miller MD, Dinubile MJ, Nguyen BY, Leavitt R, Xu X, Sklar P; SWITCHMRK 1 and 2 investigators. Switch to a raltegravir-based regimen versus continuation of a lopinavir-ritonavir-based regimen in stable HIV-infected patients with suppressed viraemia (SWITCHMRK 1 and 2): two multicentre, double-blind, randomised controlled trials. Lancet. 2010 Jan 30;375(9712):396-407. doi: 10.1016/S0140-6736(09)62041-9. Epub 2010 Jan 12.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the efficacy, safety, and tolerability of an investigational treatment for patients with HIV.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is at least 18 years of age\n* Patient is Human Immunodeficiency Virus (HIV) positive\n* Patient has documented Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) \\<50 copies/milliliter (mL) for at least 3 months while on a KALETRA based regimen\n* Patient has been on a KALETRA based regimen for at least 3 months without a change in background antiretroviral therapy\n* Patient has no documentation of HIV RNA \\>50 copies/mL for at least 3 months while on the KALETRA based regimen\n\nExclusion Criteria:\n\n* Patient is or plans to become pregnant, or nursing a child\n* Patient plans to donate eggs or impregnate/donate sperm\n* Patient is receiving Stavudine (d4T) as a component of the background antiretroviral therapy\n* Patient is currently receiving a second protease inhibitor in addition to KALETRA\n* Patient is currently receiving, or has received in the past twelve weeks, treatment for the management of elevated lipids\n* Patient has used another experimental HIV-integrase inhibitor\n* Patient has a current (active) diagnosis of acute hepatitis due to any cause\n* Patient has used systemic immunosuppressive therapy within one month prior to treatment in this study'}, 'identificationModule': {'nctId': 'NCT00443703', 'briefTitle': 'MK0518 in the Treatment of HIV-Infected Patients Switched From a Protease Inhibitor Regimen (0518-032)(TERMINATED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Multicenter, Double-Blind, Randomized, Active-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK0518 Versus KALETRA in HIV-Infected Patients Switched From a Stable KALETRA-Based Regimen - Study A', 'orgStudyIdInfo': {'id': '0518-032'}, 'secondaryIdInfos': [{'id': '2007_507'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Arm 1: MK0518 (raltegravir) + placebo to KALETRA™ (lopinavir (+) ritonavir )', 'interventionNames': ['Drug: MK0518 (raltegravir)', 'Drug: Comparator: placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Arm 2: KALETRA™ (lopinavir (+) ritonavir) + placebo to MK0518 (raltegravir)', 'interventionNames': ['Drug: Comparator: KALETRA™ (lopinavir (+) ritonavir )', 'Drug: Comparator: placebo']}], 'interventions': [{'name': 'MK0518 (raltegravir)', 'type': 'DRUG', 'otherNames': ['MK0518', 'raltegravir'], 'description': 'MK0518 (raltegravir) 400 mg by mouth (PO) twice daily (b.i.d) for up to 48 weeks of treatment', 'armGroupLabels': ['1']}, {'name': 'Comparator: KALETRA™ (lopinavir (+) ritonavir )', 'type': 'DRUG', 'otherNames': ['KALETRA'], 'description': 'KALETRA™ (lopinavir (+) ritonavir ) 400/100 mg by mouth (PO) twice daily (b.i.d.) for up to 48 weeks of treatment.', 'armGroupLabels': ['2']}, {'name': 'Comparator: placebo', 'type': 'DRUG', 'description': 'MK0518 (raltegravir) 400 mg by mouth (PO) twice daily (b.i.d.) Placebo for up to 48 weeks of treatment', 'armGroupLabels': ['2']}, {'name': 'Comparator: placebo', 'type': 'DRUG', 'description': 'KALETRA™ (lopinavir (+) ritonavir ) 400/100 mg by mouth (PO) twice daily (b.i.d.) Placebo for up to 48 weeks of treatment.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\\_Updated%20July\\_9\\_2014.pdf\n\nhttp://engagezone.msd.com/ds\\_documentation.php'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}