Viewing Study NCT02284035

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Ignite Creation Date: 2025-12-24 @ 10:22 PM
Ignite Modification Date: 2026-02-23 @ 8:08 PM
Study NCT ID: NCT02284035
Status: COMPLETED
Last Update Posted: 2025-07-20
First Post: 2014-10-28
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Safety & Efficacy of Dual Therapy With Raltegravir/Lamivudine
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'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': 'D012897', 'term': 'Slow 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': 'C098320', 'term': 'efavirenz'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ESTEBANM@clinic.cat', 'phone': '+34 93 227 54 00', 'title': 'Dr. Esteban Martínez', 'organization': 'Hospital Clinic of Barcelona'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months', 'description': 'An adverse event (AE) is any untoward occurrence to the health of a patient or clinical trial subject treated with a medicinal product and which does not necessarily have a causal relationship with this treatment.\n\nA total of 75 subjects were randomized. However, in the RAL/3TC group (n=50), one subject was excluded due to consent withdrawal prior to the initiation of medication and therefore did not complete the Baseline (randomization) visit.', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1 Raltegravir / 3TC (MK0518B)', 'description': 'Raltegravir / 3TC (MK0518B ) (50 patients)\n\nRaltegravir/3TC: MK0518B (Raltegravir/3TC) (300mg/150mg) twice daily, administered orally in the 300/150 mg film-coated tablets according to instructions in the prescribing information.', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 12, 'seriousNumAtRisk': 49, 'deathsNumAffected': 1, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Group 2 Standard Combination Therapy', 'description': 'NNRTI-Based Regimen:\n\n• EFV/TDF/FTC\n\nPI-Based Regimens:\n\nATV/r + TDF/FTC or DRV/r + TDF/FTC\n\nINSTI-Based Regimens:\n\nDTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC\n\nNNRTI-Based Regimens:\n\nEFV plus ABC/3TC or RPV/TDF/FTC\n\nPI-Based Regimen:\n\nATV/r plus ABC/3TC\n\nPI-Based Regimens:\n\nDRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC\n\nINSTI-Based Regimen:\n\nRAL plus ABC/3TC\n\nAnd other ART regimens\n\nEFV/TDF/FTC: standard combination therapy\n\nATV/r + TDF/FTC or DRV/r + TDF/FTC\n\nDTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC\n\nEFV plus ABC/3TC or RPV/TDF/FTC\n\nATV/r plus ABC/3TC\n\nDRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC\n\nRAL plus ABC/3TC\n\nOther ART regimens', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 10, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Amigdalitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Ansiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Lues', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dizziness', 'notes': 'Sickness or emesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Common cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'seriousEvents': [{'term': 'Altered blood test', 'notes': 'On May 30, 2016 goes to the emergency room. In the analysis we can see elevation of ldh, ck, anemia and thrombocytopenia not present in previous analyzes so it is admitted for study.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Prostate Neoplasia', 'notes': 'Patient with well-controlled hiv infection. Suspected prostate neoplasia (biopsy due to thrombocytopenia) with bone metastasis, metastatic medullary infiltration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'hilar adenopathies and anemia', 'notes': 'hilar adenopathies and anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Melanoma', 'notes': 'disseminated melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hernia', 'notes': 'umbilical hernia, inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'febrile syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'diarrhea', 'notes': '3-day course of diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Patients Free of Therapeutic Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 Raltegravir / 3TC (MK0518B', 'description': 'Raltegravir / 3TC (MK0518B ) (50 patients)\n\nRaltegravir/3TC: MK0518B (Raltegravir/3TC) (300mg/150mg) twice daily, administered orally in the 300/150 mg film-coated tablets according to instructions in the prescribing information.'}, {'id': 'OG001', 'title': 'Group 2 Standard Combination Therapy', 'description': 'NNRTI-Based Regimen:\n\n• EFV/TDF/FTC\n\nPI-Based Regimens:\n\nATV/r + TDF/FTC or DRV/r + TDF/FTC\n\nINSTI-Based Regimens:\n\nDTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC\n\nNNRTI-Based Regimens:\n\nEFV plus ABC/3TC or RPV/TDF/FTC\n\nPI-Based Regimen:\n\nATV/r plus ABC/3TC\n\nPI-Based Regimens:\n\nDRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC\n\nINSTI-Based Regimen:\n\nRAL plus ABC/3TC\n\nAnd other ART regimens\n\nEFV/TDF/FTC: standard combination therapy\n\nATV/r + TDF/FTC or DRV/r + TDF/FTC\n\nDTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC\n\nEFV plus ABC/3TC or RPV/TDF/FTC\n\nATV/r plus ABC/3TC\n\nDRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC\n\nRAL plus ABC/3TC\n\nOther ART regimens'}], 'classes': [{'categories': [{'title': 'No events', 'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}, {'title': 'Lost to follow up', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Pregnancy', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Stops treatment', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Virological faiulure', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Stops study medical decision', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 weeks', 'description': 'Proportion of patients free of therapeutic failure at week 24. Therapeutic failure includes virological failure, change in treatment for any reason, consent withdrawal, loss to follow-up or death', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 75 subjects were randomized. However, in the RAL/3TC group (n=50), one subject was excluded due to consent withdrawal prior to the initiation of medication and therefore did not complete the Baseline (randomization) visit.'}, {'type': 'SECONDARY', 'title': 'Efficacy in Virological Suppression Assessed With Ultrasensitive HIV-1 RNA Detection (Limit of Detection 1 Copy/mL)', 'timeFrame': '24 weeks', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Changes in Peripheral Mononuclear Blood Cells HIV-1 Reservoir', 'timeFrame': '24 weeks', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Changes in Insulin Resistance (HOMA-IR)', 'timeFrame': '24 weeks', 'description': 'Composite measure', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Changes in Body Fat Composition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 Raltegravir / 3TC (MK0518B', 'description': 'Raltegravir / 3TC (MK0518B ) (50 patients)\n\nRaltegravir/3TC: MK0518B (Raltegravir/3TC) (300mg/150mg) twice daily, administered orally in the 300/150 mg film-coated tablets according to instructions in the prescribing information.'}, {'id': 'OG001', 'title': 'Group 2 Standard Combination Therapy', 'description': 'NNRTI-Based Regimen:\n\n• EFV/TDF/FTC\n\nPI-Based Regimens:\n\nATV/r + TDF/FTC or DRV/r + TDF/FTC\n\nINSTI-Based Regimens:\n\nDTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC\n\nNNRTI-Based Regimens:\n\nEFV plus ABC/3TC or RPV/TDF/FTC\n\nPI-Based Regimen:\n\nATV/r plus ABC/3TC\n\nPI-Based Regimens:\n\nDRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC\n\nINSTI-Based Regimen:\n\nRAL plus ABC/3TC\n\nAnd other ART regimens\n\nEFV/TDF/FTC: standard combination therapy\n\nATV/r + TDF/FTC or DRV/r + TDF/FTC\n\nDTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC\n\nEFV plus ABC/3TC or RPV/TDF/FTC\n\nATV/r plus ABC/3TC\n\nDRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC\n\nRAL plus ABC/3TC\n\nOther ART regimens'}], 'classes': [{'title': 'Baseline extremities fat percentage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54.13', 'spread': '19.44', 'groupId': 'OG000'}, {'value': '49.43', 'spread': '21.26', 'groupId': 'OG001'}]}]}, {'title': 'Baseline total fat percentage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.50', 'spread': '7.62', 'groupId': 'OG000'}, {'value': '27.54', 'spread': '8.75', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 extremities fat percentage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54.09', 'spread': '17.68', 'groupId': 'OG000'}, {'value': '50.21', 'spread': '23.77', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 total fat percentage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.84', 'spread': '7.23', 'groupId': 'OG000'}, {'value': '28.78', 'spread': '9.55', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'Composite measure', 'unitOfMeasure': 'percentage of fat weight', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some patients were not performed a DEXA during the study'}, {'type': 'SECONDARY', 'title': 'Changes in Plasma 25-OH Vitamin D Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 Raltegravir / 3TC (MK0518B', 'description': 'Raltegravir / 3TC (MK0518B ) (50 patients)\n\nRaltegravir/3TC: MK0518B (Raltegravir/3TC) (300mg/150mg) twice daily, administered orally in the 300/150 mg film-coated tablets according to instructions in the prescribing information.'}, {'id': 'OG001', 'title': 'Group 2 Standard Combination Therapy', 'description': 'NNRTI-Based Regimen:\n\n• EFV/TDF/FTC\n\nPI-Based Regimens:\n\nATV/r + TDF/FTC or DRV/r + TDF/FTC\n\nINSTI-Based Regimens:\n\nDTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC\n\nNNRTI-Based Regimens:\n\nEFV plus ABC/3TC or RPV/TDF/FTC\n\nPI-Based Regimen:\n\nATV/r plus ABC/3TC\n\nPI-Based Regimens:\n\nDRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC\n\nINSTI-Based Regimen:\n\nRAL plus ABC/3TC\n\nAnd other ART regimens\n\nEFV/TDF/FTC: standard combination therapy\n\nATV/r + TDF/FTC or DRV/r + TDF/FTC\n\nDTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC\n\nEFV plus ABC/3TC or RPV/TDF/FTC\n\nATV/r plus ABC/3TC\n\nDRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC\n\nRAL plus ABC/3TC\n\nOther ART regimens'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.4', 'spread': '9.0', 'groupId': 'OG000'}, {'value': '16.7', 'spread': '9.6', 'groupId': 'OG001'}]}]}, {'title': 'week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.5', 'spread': '15.1', 'groupId': 'OG000'}, {'value': '26.5', 'spread': '17.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some patients vitamine D determination was not available'}, {'type': 'SECONDARY', 'title': 'Changes in Estimated Glomerular Filtration Rate (CKD-EPI)', 'timeFrame': '24 weeks', 'description': 'Composite measure', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Changes in CD38', 'timeFrame': '24 weeks', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Changes in IL-6', 'timeFrame': '24 weeks', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Changes in Sleep Quality (Pittsburgh Sleep Quality Index)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 Raltegravir / 3TC (MK0518B', 'description': 'Raltegravir / 3TC (MK0518B ) (50 patients)\n\nRaltegravir/3TC: MK0518B (Raltegravir/3TC) (300mg/150mg) twice daily, administered orally in the 300/150 mg film-coated tablets according to instructions in the prescribing information.'}, {'id': 'OG001', 'title': 'Group 2 Standard Combination Therapy', 'description': 'NNRTI-Based Regimen:\n\n• EFV/TDF/FTC\n\nPI-Based Regimens:\n\nATV/r + TDF/FTC or DRV/r + TDF/FTC\n\nINSTI-Based Regimens:\n\nDTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC\n\nNNRTI-Based Regimens:\n\nEFV plus ABC/3TC or RPV/TDF/FTC\n\nPI-Based Regimen:\n\nATV/r plus ABC/3TC\n\nPI-Based Regimens:\n\nDRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC\n\nINSTI-Based Regimen:\n\nRAL plus ABC/3TC\n\nAnd other ART regimens\n\nEFV/TDF/FTC: standard combination therapy\n\nATV/r + TDF/FTC or DRV/r + TDF/FTC\n\nDTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC\n\nEFV plus ABC/3TC or RPV/TDF/FTC\n\nATV/r plus ABC/3TC\n\nDRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC\n\nRAL plus ABC/3TC\n\nOther ART regimens'}], 'classes': [{'title': 'Baseline score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '3.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.8', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '3.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'The Pittsburgh Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in adults. It differentiates "poor" from "good" sleep quality by measuring seven áreas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over the last month.\n\nThe posible range of the scale is from 0 to 21 points. The greater the score the poorest is the sleep quality.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some patients did not complete the questionnaire'}, {'type': 'SECONDARY', 'title': 'Changes in Adherence in Both Treatment Arms (Morisky-Green Test)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 Raltegravir / 3TC (MK0518B', 'description': 'Raltegravir / 3TC (MK0518B ) (50 patients)\n\nRaltegravir/3TC: MK0518B (Raltegravir/3TC) (300mg/150mg) twice daily, administered orally in the 300/150 mg film-coated tablets according to instructions in the prescribing information.'}, {'id': 'OG001', 'title': 'Group 2 Standard Combination Therapy', 'description': 'NNRTI-Based Regimen:\n\n• EFV/TDF/FTC\n\nPI-Based Regimens:\n\nATV/r + TDF/FTC or DRV/r + TDF/FTC\n\nINSTI-Based Regimens:\n\nDTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC\n\nNNRTI-Based Regimens:\n\nEFV plus ABC/3TC or RPV/TDF/FTC\n\nPI-Based Regimen:\n\nATV/r plus ABC/3TC\n\nPI-Based Regimens:\n\nDRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC\n\nINSTI-Based Regimen:\n\nRAL plus ABC/3TC\n\nAnd other ART regimens\n\nEFV/TDF/FTC: standard combination therapy\n\nATV/r + TDF/FTC or DRV/r + TDF/FTC\n\nDTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC\n\nEFV plus ABC/3TC or RPV/TDF/FTC\n\nATV/r plus ABC/3TC\n\nDRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC\n\nRAL plus ABC/3TC\n\nOther ART regimens'}], 'classes': [{'title': 'Baseline', 'categories': [{'title': 'Adherent', 'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': 'Non adherent', 'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}, {'title': 'Not evaluated/ Lost follow Up', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'categories': [{'title': 'Adherent', 'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}, {'title': 'Non adherent', 'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Not evaluated/ Lost follow Up', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 weeks', 'description': 'Patients were asked to complete the Morisky-Green questionnaire:\n\nSome people forget to take their medication as prescribed. How often does it happen to you? (Always/often/sometimes/rarely/never) Some people forget some taking of the medication or change the prescribed schedule / take to adapt it to their own needs. How often do you do it? (Always/often/sometimes/rarely/never) Some people stop taking their medications as prescribed when they feel better. How often do you do it? (Always/often/sometimes/rarely/never) Some people stop taking their medications as prescribed when they feel worse. How often do you do it? (Always/often/sometimes/rarely/never)\n\nOnly if patients answered never to each four questions, they were considered adherent; if not, non adherent.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Some patients did not complete the questionnaire'}, {'type': 'SECONDARY', 'title': 'Changes in Total Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 Raltegravir / 3TC (MK0518B', 'description': 'Raltegravir / 3TC (MK0518B ) (50 patients)\n\nRaltegravir/3TC: MK0518B (Raltegravir/3TC) (300mg/150mg) twice daily, administered orally in the 300/150 mg film-coated tablets according to instructions in the prescribing information.'}, {'id': 'OG001', 'title': 'Group 2 Standard Combination Therapy', 'description': 'NNRTI-Based Regimen:\n\n• EFV/TDF/FTC\n\nPI-Based Regimens:\n\nATV/r + TDF/FTC or DRV/r + TDF/FTC\n\nINSTI-Based Regimens:\n\nDTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC\n\nNNRTI-Based Regimens:\n\nEFV plus ABC/3TC or RPV/TDF/FTC\n\nPI-Based Regimen:\n\nATV/r plus ABC/3TC\n\nPI-Based Regimens:\n\nDRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC\n\nINSTI-Based Regimen:\n\nRAL plus ABC/3TC\n\nAnd other ART regimens\n\nEFV/TDF/FTC: standard combination therapy\n\nATV/r + TDF/FTC or DRV/r + TDF/FTC\n\nDTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC\n\nEFV plus ABC/3TC or RPV/TDF/FTC\n\nATV/r plus ABC/3TC\n\nDRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC\n\nRAL plus ABC/3TC\n\nOther ART regimens'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '189', 'spread': '46', 'groupId': 'OG000'}, {'value': '187', 'spread': '44', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '190', 'spread': '45', 'groupId': 'OG000'}, {'value': '186', 'spread': '37', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some patients have not performed all the protocol determinations'}, {'type': 'SECONDARY', 'title': 'Changes in HDL Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 Raltegravir / 3TC (MK0518B', 'description': 'Raltegravir / 3TC (MK0518B ) (50 patients)\n\nRaltegravir/3TC: MK0518B (Raltegravir/3TC) (300mg/150mg) twice daily, administered orally in the 300/150 mg film-coated tablets according to instructions in the prescribing information.'}, {'id': 'OG001', 'title': 'Group 2 Standard Combination Therapy', 'description': 'NNRTI-Based Regimen:\n\n• EFV/TDF/FTC\n\nPI-Based Regimens:\n\nATV/r + TDF/FTC or DRV/r + TDF/FTC\n\nINSTI-Based Regimens:\n\nDTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC\n\nNNRTI-Based Regimens:\n\nEFV plus ABC/3TC or RPV/TDF/FTC\n\nPI-Based Regimen:\n\nATV/r plus ABC/3TC\n\nPI-Based Regimens:\n\nDRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC\n\nINSTI-Based Regimen:\n\nRAL plus ABC/3TC\n\nAnd other ART regimens\n\nEFV/TDF/FTC: standard combination therapy\n\nATV/r + TDF/FTC or DRV/r + TDF/FTC\n\nDTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC\n\nEFV plus ABC/3TC or RPV/TDF/FTC\n\nATV/r plus ABC/3TC\n\nDRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC\n\nRAL plus ABC/3TC\n\nOther ART regimens'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48', 'spread': '15', 'groupId': 'OG000'}, {'value': '46', 'spread': '13', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49', 'spread': '14', 'groupId': 'OG000'}, {'value': '45', 'spread': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some patients did not performed all the determinations'}, {'type': 'SECONDARY', 'title': 'Changes in LDL Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 Raltegravir / 3TC (MK0518B', 'description': 'Raltegravir / 3TC (MK0518B ) (50 patients)\n\nRaltegravir/3TC: MK0518B (Raltegravir/3TC) (300mg/150mg) twice daily, administered orally in the 300/150 mg film-coated tablets according to instructions in the prescribing information.'}, {'id': 'OG001', 'title': 'Group 2 Standard Combination Therapy', 'description': 'NNRTI-Based Regimen:\n\n• EFV/TDF/FTC\n\nPI-Based Regimens:\n\nATV/r + TDF/FTC or DRV/r + TDF/FTC\n\nINSTI-Based Regimens:\n\nDTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC\n\nNNRTI-Based Regimens:\n\nEFV plus ABC/3TC or RPV/TDF/FTC\n\nPI-Based Regimen:\n\nATV/r plus ABC/3TC\n\nPI-Based Regimens:\n\nDRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC\n\nINSTI-Based Regimen:\n\nRAL plus ABC/3TC\n\nAnd other ART regimens\n\nEFV/TDF/FTC: standard combination therapy\n\nATV/r + TDF/FTC or DRV/r + TDF/FTC\n\nDTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC\n\nEFV plus ABC/3TC or RPV/TDF/FTC\n\nATV/r plus ABC/3TC\n\nDRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC\n\nRAL plus ABC/3TC\n\nOther ART regimens'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '120', 'spread': '39', 'groupId': 'OG000'}, {'value': '115', 'spread': '29', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '119', 'spread': '40', 'groupId': 'OG000'}, {'value': '118', 'spread': '33', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some patients did not perform all the determinations'}, {'type': 'SECONDARY', 'title': 'Changes in Triglycerides', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 Raltegravir / 3TC (MK0518B', 'description': 'Raltegravir / 3TC (MK0518B ) (50 patients)\n\nRaltegravir/3TC: MK0518B (Raltegravir/3TC) (300mg/150mg) twice daily, administered orally in the 300/150 mg film-coated tablets according to instructions in the prescribing information.'}, {'id': 'OG001', 'title': 'Group 2 Standard Combination Therapy', 'description': 'NNRTI-Based Regimen:\n\n• EFV/TDF/FTC\n\nPI-Based Regimens:\n\nATV/r + TDF/FTC or DRV/r + TDF/FTC\n\nINSTI-Based Regimens:\n\nDTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC\n\nNNRTI-Based Regimens:\n\nEFV plus ABC/3TC or RPV/TDF/FTC\n\nPI-Based Regimen:\n\nATV/r plus ABC/3TC\n\nPI-Based Regimens:\n\nDRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC\n\nINSTI-Based Regimen:\n\nRAL plus ABC/3TC\n\nAnd other ART regimens\n\nEFV/TDF/FTC: standard combination therapy\n\nATV/r + TDF/FTC or DRV/r + TDF/FTC\n\nDTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC\n\nEFV plus ABC/3TC or RPV/TDF/FTC\n\nATV/r plus ABC/3TC\n\nDRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC\n\nRAL plus ABC/3TC\n\nOther ART regimens'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.5', 'spread': '49.9', 'groupId': 'OG000'}, {'value': '112.0', 'spread': '53.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '97.7', 'spread': '44.8', 'groupId': 'OG000'}, {'value': '100.9', 'spread': '37.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients did not perform all the determinations'}, {'type': 'SECONDARY', 'title': 'Changes in Bone Mineral Density', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 Raltegravir / 3TC (MK0518B', 'description': 'Raltegravir / 3TC (MK0518B ) (50 patients)\n\nRaltegravir/3TC: MK0518B (Raltegravir/3TC) (300mg/150mg) twice daily, administered orally in the 300/150 mg film-coated tablets according to instructions in the prescribing information.'}, {'id': 'OG001', 'title': 'Group 2 Standard Combination Therapy', 'description': 'NNRTI-Based Regimen:\n\n• EFV/TDF/FTC\n\nPI-Based Regimens:\n\nATV/r + TDF/FTC or DRV/r + TDF/FTC\n\nINSTI-Based Regimens:\n\nDTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC\n\nNNRTI-Based Regimens:\n\nEFV plus ABC/3TC or RPV/TDF/FTC\n\nPI-Based Regimen:\n\nATV/r plus ABC/3TC\n\nPI-Based Regimens:\n\nDRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC\n\nINSTI-Based Regimen:\n\nRAL plus ABC/3TC\n\nAnd other ART regimens\n\nEFV/TDF/FTC: standard combination therapy\n\nATV/r + TDF/FTC or DRV/r + TDF/FTC\n\nDTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC\n\nEFV plus ABC/3TC or RPV/TDF/FTC\n\nATV/r plus ABC/3TC\n\nDRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC\n\nRAL plus ABC/3TC\n\nOther ART regimens'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1166.1', 'spread': '100.9', 'groupId': 'OG000'}, {'value': '1211.6', 'spread': '79.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1183.0', 'spread': '98.5', 'groupId': 'OG000'}, {'value': '1247.4', 'spread': '80.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'DEXA', 'unitOfMeasure': 'gr/cm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Not all the patients performed the DEXA'}, {'type': 'SECONDARY', 'title': 'Changes in Urine Beta-2-microglobulin/Creatinine Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 Raltegravir / 3TC (MK0518B', 'description': 'Raltegravir / 3TC (MK0518B ) (50 patients)\n\nRaltegravir/3TC: MK0518B (Raltegravir/3TC) (300mg/150mg) twice daily, administered orally in the 300/150 mg film-coated tablets according to instructions in the prescribing information.'}, {'id': 'OG001', 'title': 'Group 2 Standard Combination Therapy', 'description': 'NNRTI-Based Regimen:\n\n• EFV/TDF/FTC\n\nPI-Based Regimens:\n\nATV/r + TDF/FTC or DRV/r + TDF/FTC\n\nINSTI-Based Regimens:\n\nDTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC\n\nNNRTI-Based Regimens:\n\nEFV plus ABC/3TC or RPV/TDF/FTC\n\nPI-Based Regimen:\n\nATV/r plus ABC/3TC\n\nPI-Based Regimens:\n\nDRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC\n\nINSTI-Based Regimen:\n\nRAL plus ABC/3TC\n\nAnd other ART regimens\n\nEFV/TDF/FTC: standard combination therapy\n\nATV/r + TDF/FTC or DRV/r + TDF/FTC\n\nDTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC\n\nEFV plus ABC/3TC or RPV/TDF/FTC\n\nATV/r plus ABC/3TC\n\nDRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC\n\nRAL plus ABC/3TC\n\nOther ART regimens'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '672.8', 'spread': '773.3', 'groupId': 'OG000'}, {'value': '595.3', 'spread': '948.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '275.7', 'spread': '227.2', 'groupId': 'OG000'}, {'value': '788.5', 'spread': '1587.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'unitOfMeasure': 'mg/g', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some patients did not performed this determination'}, {'type': 'SECONDARY', 'title': 'Changes in HLA-DR', 'timeFrame': '24 weeks', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Changes in High Sensitivity C-reactive Protein', 'timeFrame': '24 weeks', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Changes in Mononuclear Activation SD-14', 'timeFrame': '24 weeks', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Changes in Mononuclear Activation SD-163', 'timeFrame': '24 weeks', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1 Raltegravir / 3TC (MK0518B)', 'description': 'Raltegravir / 3TC (MK0518B )\n\nRaltegravir/3TC: MK0518B (Raltegravir/3TC) (300mg/150mg) twice daily, administered orally in the 300/150 mg film-coated tablets according to instructions in the prescribing information.'}, {'id': 'FG001', 'title': 'Group 2 Standard Combination Therapy', 'description': 'NNRTI-Based Regimen:\n\n• EFV/TDF/FTC\n\nPI-Based Regimens:\n\nATV/r + TDF/FTC or DRV/r + TDF/FTC\n\nINSTI-Based Regimens:\n\nDTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC\n\nNNRTI-Based Regimens:\n\nEFV plus ABC/3TC or RPV/TDF/FTC\n\nPI-Based Regimen:\n\nATV/r plus ABC/3TC\n\nPI-Based Regimens:\n\nDRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC\n\nINSTI-Based Regimen:\n\nRAL plus ABC/3TC\n\nAnd other ART regimens\n\nEFV/TDF/FTC: standard combination therapy\n\nATV/r + TDF/FTC or DRV/r + TDF/FTC\n\nDTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC\n\nEFV plus ABC/3TC or RPV/TDF/FTC\n\nATV/r plus ABC/3TC\n\nDRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC\n\nRAL plus ABC/3TC\n\nOther ART regimens'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'preAssignmentDetails': 'A total of 75 participants were enrolled and randomized. One participant assigned to the Raltegravir/Lamivudine arm withdrew consent before starting treatment and was excluded from the analysis. As a result, 74 participants initiated treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1 Raltegravir / 3TC (MK0518B)', 'description': 'Raltegravir / 3TC (MK0518B )\n\nRaltegravir/3TC: MK0518B (Raltegravir/3TC) (300mg/150mg) twice daily, administered orally in the 300/150 mg film-coated tablets according to instructions in the prescribing information.'}, {'id': 'BG001', 'title': 'Group 2 Standard Combination Therapy', 'description': 'NNRTI-Based Regimen:\n\n• EFV/TDF/FTC\n\nPI-Based Regimens:\n\nATV/r + TDF/FTC or DRV/r + TDF/FTC\n\nINSTI-Based Regimens:\n\nDTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC\n\nNNRTI-Based Regimens:\n\nEFV plus ABC/3TC or RPV/TDF/FTC\n\nPI-Based Regimen:\n\nATV/r plus ABC/3TC\n\nPI-Based Regimens:\n\nDRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC\n\nINSTI-Based Regimen:\n\nRAL plus ABC/3TC\n\nAnd other ART regimens\n\nEFV/TDF/FTC: standard combination therapy\n\nATV/r + TDF/FTC or DRV/r + TDF/FTC\n\nDTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC\n\nEFV plus ABC/3TC or RPV/TDF/FTC\n\nATV/r plus ABC/3TC\n\nDRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC\n\nRAL plus ABC/3TC\n\nOther ART regimens'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50', 'spread': '12', 'groupId': 'BG000'}, {'value': '50', 'spread': '13', 'groupId': 'BG001'}, {'value': '50', 'spread': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '58', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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'}], 'populationDescription': 'Baseline measures are reported for the 74 participants who initiated treatment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-11-07', 'size': 610382, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-05-21T03:49', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-18', 'studyFirstSubmitDate': '2014-10-28', 'resultsFirstSubmitDate': '2017-08-10', 'studyFirstSubmitQcDate': '2014-11-03', 'lastUpdatePostDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-07-18', 'studyFirstPostDateStruct': {'date': '2014-11-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Patients Free of Therapeutic Failure', 'timeFrame': '24 weeks', 'description': 'Proportion of patients free of therapeutic failure at week 24. Therapeutic failure includes virological failure, change in treatment for any reason, consent withdrawal, loss to follow-up or death'}], 'secondaryOutcomes': [{'measure': 'Efficacy in Virological Suppression Assessed With Ultrasensitive HIV-1 RNA Detection (Limit of Detection 1 Copy/mL)', 'timeFrame': '24 weeks'}, {'measure': 'Changes in Peripheral Mononuclear Blood Cells HIV-1 Reservoir', 'timeFrame': '24 weeks'}, {'measure': 'Changes in Insulin Resistance (HOMA-IR)', 'timeFrame': '24 weeks', 'description': 'Composite measure'}, {'measure': 'Changes in Body Fat Composition', 'timeFrame': '24 weeks', 'description': 'Composite measure'}, {'measure': 'Changes in Plasma 25-OH Vitamin D Levels', 'timeFrame': '24 weeks'}, {'measure': 'Changes in Estimated Glomerular Filtration Rate (CKD-EPI)', 'timeFrame': '24 weeks', 'description': 'Composite measure'}, {'measure': 'Changes in CD38', 'timeFrame': '24 weeks'}, {'measure': 'Changes in IL-6', 'timeFrame': '24 weeks'}, {'measure': 'Changes in Sleep Quality (Pittsburgh Sleep Quality Index)', 'timeFrame': '24 weeks', 'description': 'The Pittsburgh Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in adults. It differentiates "poor" from "good" sleep quality by measuring seven áreas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over the last month.\n\nThe posible range of the scale is from 0 to 21 points. The greater the score the poorest is the sleep quality.'}, {'measure': 'Changes in Adherence in Both Treatment Arms (Morisky-Green Test)', 'timeFrame': '24 weeks', 'description': 'Patients were asked to complete the Morisky-Green questionnaire:\n\nSome people forget to take their medication as prescribed. How often does it happen to you? (Always/often/sometimes/rarely/never) Some people forget some taking of the medication or change the prescribed schedule / take to adapt it to their own needs. How often do you do it? (Always/often/sometimes/rarely/never) Some people stop taking their medications as prescribed when they feel better. How often do you do it? (Always/often/sometimes/rarely/never) Some people stop taking their medications as prescribed when they feel worse. How often do you do it? (Always/often/sometimes/rarely/never)\n\nOnly if patients answered never to each four questions, they were considered adherent; if not, non adherent.'}, {'measure': 'Changes in Total Cholesterol', 'timeFrame': '24 weeks'}, {'measure': 'Changes in HDL Cholesterol', 'timeFrame': '24 weeks'}, {'measure': 'Changes in LDL Cholesterol', 'timeFrame': '24 weeks'}, {'measure': 'Changes in Triglycerides', 'timeFrame': '24 weeks'}, {'measure': 'Changes in Bone Mineral Density', 'timeFrame': '24 weeks', 'description': 'DEXA'}, {'measure': 'Changes in Urine Beta-2-microglobulin/Creatinine Ratio', 'timeFrame': '24 weeks'}, {'measure': 'Changes in HLA-DR', 'timeFrame': '24 weeks'}, {'measure': 'Changes in High Sensitivity C-reactive Protein', 'timeFrame': '24 weeks'}, {'measure': 'Changes in Mononuclear Activation SD-14', 'timeFrame': '24 weeks'}, {'measure': 'Changes in Mononuclear Activation SD-163', 'timeFrame': '24 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['AIDS']}, 'descriptionModule': {'briefSummary': 'A pilot 24-week open-label, randomized, controlled clinical trial to assess the safety, tolerability and efficacy of dual therapy with Raltegravir/Lamivudine combination when replacing standard combination therapy in HIV-infected patients with prolonged virological suppression'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Eligible patients will be males or females at least 18 years of age. Women of childbearing potential must have a negative pregnancy test within 10 days prior to randomization into the study.\n2. Patients seropositive for HIV-1 using standard diagnostic criteria.\n3. Patients virologically suppressed during at least 12 months prior to inclusion (viral load \\<50 copies/mL).\n4. Patients on combination antiretroviral therapy (at least 2 antiretroviral drugs) for at least 12 months before being randomized in this study.\n5. Patients who are clinically stable in the opinion of the investigator at study entry (clinical status and chronic medication must not have not been modified at least 14 days prior to randomization).\n6. Patients who have signed informed consent to participate in the study.\n\nExclusion Criteria:\n\n1. Pregnancy, lactation, or planned pregnancy during the study period.\n2. Previous failure to an integrase inhibitor-containing regimen.\n3. Previous failure to a 3TC or FTC-containing regimen.\n4. Resistance mutations to 3TC or integrase inhibitor if any resistance test had been previously performed.\n5. Any disease or history of disease which, in the opinion of the investigator, might confound the results of the study or pose additional risk to patient treatment.\n6. Chronic hepatitis B.'}, 'identificationModule': {'nctId': 'NCT02284035', 'acronym': 'RALAM', 'briefTitle': 'Safety & Efficacy of Dual Therapy With Raltegravir/Lamivudine', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Clinic of Barcelona'}, 'officialTitle': 'Pilot 24week Clinical Trial to Assess the Safety, Tolerability and Efficacy of Dual Therapy With Raltegravir/Lamivudine Combination, Replacing Standard Combination Therapy in HIV-infected Pts With Prolonged Virological Suppression.', 'orgStudyIdInfo': {'id': 'RALAM'}, 'secondaryIdInfos': [{'id': '2014-003142-27', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1 Raltegravir / 3TC (MK0518B', 'description': 'Raltegravir / 3TC (MK0518B ) (50 patients)', 'interventionNames': ['Drug: Raltegravir/3TC']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2 standard combination therapy', 'description': 'NNRTI-Based Regimen:\n\n• EFV/TDF/FTC\n\nPI-Based Regimens:\n\nATV/r + TDF/FTC or DRV/r + TDF/FTC\n\nINSTI-Based Regimens:\n\nDTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC\n\nNNRTI-Based Regimens:\n\nEFV plus ABC/3TC or RPV/TDF/FTC\n\nPI-Based Regimen:\n\nATV/r plus ABC/3TC\n\nPI-Based Regimens:\n\nDRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC\n\nINSTI-Based Regimen:\n\nRAL plus ABC/3TC\n\nAnd other ART regimens', 'interventionNames': ['Drug: EFV/TDF/FTC', 'Drug: ATV/r + TDF/FTC or DRV/r + TDF/FTC', 'Drug: DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC', 'Drug: EFV plus ABC/3TC or RPV/TDF/FTC', 'Drug: ATV/r plus ABC/3TC', 'Drug: DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC', 'Drug: RAL plus ABC/3TC', 'Drug: Other ART regimens']}], 'interventions': [{'name': 'Raltegravir/3TC', 'type': 'DRUG', 'description': 'MK0518B (Raltegravir/3TC) (300mg/150mg) twice daily, administered orally in the 300/150 mg film-coated tablets according to instructions in the prescribing information.', 'armGroupLabels': ['Group 1 Raltegravir / 3TC (MK0518B']}, {'name': 'EFV/TDF/FTC', 'type': 'DRUG', 'otherNames': ['NNRTI-Based Regimen'], 'description': 'standard combination therapy', 'armGroupLabels': ['Group 2 standard combination therapy']}, {'name': 'ATV/r + TDF/FTC or DRV/r + TDF/FTC', 'type': 'DRUG', 'otherNames': ['PI-Based Regimens'], 'armGroupLabels': ['Group 2 standard combination therapy']}, {'name': 'DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC', 'type': 'DRUG', 'otherNames': ['INSTI-Based Regimens'], 'armGroupLabels': ['Group 2 standard combination therapy']}, {'name': 'EFV plus ABC/3TC or RPV/TDF/FTC', 'type': 'DRUG', 'otherNames': ['NNRTI-Based Regimens'], 'armGroupLabels': ['Group 2 standard combination therapy']}, {'name': 'ATV/r plus ABC/3TC', 'type': 'DRUG', 'otherNames': ['PI-Based Regimen'], 'armGroupLabels': ['Group 2 standard combination therapy']}, {'name': 'DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC', 'type': 'DRUG', 'otherNames': ['PI-Based Regimens'], 'armGroupLabels': ['Group 2 standard combination therapy']}, {'name': 'RAL plus ABC/3TC', 'type': 'DRUG', 'otherNames': ['INSTI-Based Regimen'], 'armGroupLabels': ['Group 2 standard combination therapy']}, {'name': 'Other ART regimens', 'type': 'DRUG', 'armGroupLabels': ['Group 2 standard combination therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Esteban Martinez, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Clinic of Barcelona'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Juan A. Arnaiz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Head Clinical Trials Unit', 'investigatorFullName': 'Juan A. Arnaiz', 'investigatorAffiliation': 'Hospital Clinic of Barcelona'}}}}