Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2026-01-04 @ 1:48 PM
Study NCT ID:
NCT02652793
Status:
COMPLETED
Last Update Posted:
2025-07-02
First Post:
2015-12-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Simplification From Tenofovir Plus Lamivudine or Emtricitabine Plus Ritonavir-Boosted-Protease Inhibitor to Ritonavir-Boosted-Atazanavir Plus Lamivudine in Virologically-Suppressed-HIVInfected Adults With Osteopenia
Sponsor:
Organization:
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': 'D019259', 'term': 'Lamivudine'}], 'ancestors': [{'id': 'D016047', 'term': 'Zalcitabine'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D015224', 'term': 'Dideoxynucleosides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jlblanco@clinic.cat', 'phone': '+34 932275400', 'title': 'Dr. José Luis Blanco', 'organization': 'Hospital Clinic of Barcelona'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'This pilot study had a small sample size and did not reach the planned enrollment of 45 participants.'}}, 'adverseEventsModule': {'timeFrame': 'From informed consent to Week 48 (end of study visit)', 'description': 'Adverse events were collected from the time of informed consent until the final study visit (Week 48). Severity was graded using the AIDS Clinical Trial Group (ACTG) Grading Scale. All AEs were recorded regardless of suspected relationship to study drug. Serious adverse events were defined per ICH-GCP guidelines.', 'eventGroups': [{'id': 'EG000', 'title': 'RTV-Boosted-ATV + 3TC', 'description': 'Participants switched from a stable antiretroviral regimen containing tenofovir disoproxil fumarate plus lamivudine or emtricitabine plus ritonavir-boosted protease inhibitor to a simplified regimen of ritonavir-boosted atazanavir (300/100 mg) plus lamivudine (300 mg) once daily for 48 weeks.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 2, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Bone Mineral Density (BMD) at Lumbar Spine and Left Hip From Baseline to Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RTV-Boosted-ATV + 3TC', 'description': 'Participants switched from a stable antiretroviral regimen containing tenofovir disoproxil fumarate plus lamivudine or emtricitabine plus ritonavir-boosted protease inhibitor to a simplified regimen of ritonavir-boosted atazanavir (300/100 mg) plus lamivudine (300 mg) once daily for 48 weeks.'}], 'classes': [{'title': 'Lumbar Spine', 'categories': [{'measurements': [{'value': '0.010', 'spread': '0.030', 'groupId': 'OG000'}]}]}, {'title': 'Left Hip', 'categories': [{'measurements': [{'value': '0.013', 'spread': '0.030', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0239', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.010', 'ciLowerLimit': '0.001', 'ciUpperLimit': '0.019', 'pValueComment': 'Statistical test applied to lumbar spine BMD only. P-value reflects within-group change from baseline to Week 48.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.03', 'estimateComment': 'Represents mean change in lumbar spine BMD from baseline to Week 48.', 'groupDescription': 'Single-arm study; no comparator group', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Per-protocol analysis; missing data excluded', 'nonInferiorityComment': 'Single-arm pilot study to assess BMD improvement after switching therapy. Null hypothesis: no change in lumbar spine BMD at Week 48. Sample size of 45 planned to detect a 2% increase with 90% power (α=0.025). Final analysis included 30 participants.'}, {'pValue': '0.0046', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.013', 'ciLowerLimit': '0.004', 'ciUpperLimit': '0.023', 'pValueComment': 'Left hip', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.03', 'estimateComment': 'Represents mean change in left hip BMD from baseline to Week 48', 'groupDescription': 'Single-arm study; no comparator group', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Statistical test applied to left hip BMD only. P-value reflects within-group change from baseline to Week 48.', 'nonInferiorityComment': 'Single-arm pilot study to assess BMD improvement after switching therapy. Null hypothesis: no change in left hip BMD at Week 48. Sample size of 45 planned to detect a 2% increase with 90% power (α=0.025). Final analysis included 30 participants.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 48', 'description': 'Mean change in BMD (g/cm²) at lumbar spine (L1-L4) and left hip measured by dual-energy X-ray absorptiometry (DXA) in human immunodeficiency virus-infected adults with hip or spine T-score between \\< -1.0 and \\>-2.5', 'unitOfMeasure': 'g/cm²', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients Free of Virologic Failure (Confirmed Viral Load≥ 50 Copies/mL)', 'timeFrame': '48 weeks', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients With Adverse Effects', 'timeFrame': '48 weeks', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Bone Turnover Markers in Blood: Urinary N-terminal Telopeptide of Type-1 Collagen', 'timeFrame': '48 weeks', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Bone Turnover Markers in Blood: Bone-specific Alkaline Phosphatase', 'timeFrame': '48 weeks', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Renald Disfunction Parameter: Estimated Glomerular Filtration Rate', 'timeFrame': '48 weeks', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Renald Disfunction Parameter: Phosphorus in Blood Sample', 'timeFrame': '48 weeks', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Renald Disfunction, Tubule Dysfunction, Parameter: Glucose in Urine', 'timeFrame': '48 weeks', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Renald Disfunction, Tubule Dysfunction, Parameter: Protein in Urine Samples', 'timeFrame': '48 weeks', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Renald Disfunction, Tubule Dysfunction, Parameter: Albumin in Urine Samples', 'timeFrame': '48 weeks', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Renald Disfunction, Tubule Dysfunction, Parameter: Creatinin in Urine Samples', 'timeFrame': '48 weeks', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Renald Disfunction, Tubule Dysfunction, Parameter: Phosphorus in Urine Samples', 'timeFrame': '48 weeks', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Renald Disfunction, Tubule Dysfunction, Parameter: Beta-2 Microglobulin in Urine Samples', 'timeFrame': '48 weeks', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Renald Disfunction, Tubule Dysfunction, Parameter: N-Acetyl-β-D Glucosaminidase in Urine Samples', 'timeFrame': '48 weeks', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'RTV-Boosted-ATV + 3TC', 'description': 'Participants switched from a stable antiretroviral regimen containing tenofovir disoproxil fumarate plus lamivudine or emtricitabine plus ritonavir-boosted protease inhibitor to a simplified regimen of ritonavir-boosted atazanavir (300/100 mg) plus lamivudine (300 mg) once daily for 48 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were recruited at a single center (Infectious Diseases Department, Hospital Clínic, University of Barcelona) between November 2015 and November 2017. Recruitment targeted virologically suppressed HIV-infected adults with osteopenia receiving tenofovir-based ART.', 'preAssignmentDetails': 'Of the 60 individuals screened, 29 were excluded prior to assignment due to normal bone mineral density, prior virological failure, hypogonadism, or contraindicated medications. A total of 31 participants were enrolled and switched to the study regimen.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'RTV-Boosted-ATV + 3TC', 'description': 'Participants switched from a stable antiretroviral regimen containing tenofovir disoproxil fumarate plus lamivudine or emtricitabine plus ritonavir-boosted protease inhibitor to a simplified regimen of ritonavir-boosted atazanavir (300/100 mg) plus lamivudine (300 mg) once daily for 48 weeks.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000', 'lowerLimit': '33', 'upperLimit': '47'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Spain', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Bone Mineral Density (BMD) at Baseline by DXA', 'classes': [{'title': 'Lumbar Spine', 'categories': [{'measurements': [{'value': '0.88', 'groupId': 'BG000', 'lowerLimit': '0.80', 'upperLimit': '0.90'}]}]}, {'title': 'Left Hip', 'categories': [{'measurements': [{'value': '0.72', 'groupId': 'BG000', 'lowerLimit': '0.68', 'upperLimit': '0.76'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'g/cm²', 'dispersionType': 'INTER_QUARTILE_RANGE'}], 'populationDescription': 'Of the 31 participants enrolled, 1 did not initiate treatment after screening and was excluded from all analyses. Therefore, the baseline and analysis population included 30 participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-10-06', 'size': 627138, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-06-10T05:03', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2018-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-30', 'studyFirstSubmitDate': '2015-12-31', 'resultsFirstSubmitDate': '2025-06-13', 'studyFirstSubmitQcDate': '2016-01-08', 'lastUpdatePostDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-30', 'studyFirstPostDateStruct': {'date': '2016-01-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Bone Mineral Density (BMD) at Lumbar Spine and Left Hip From Baseline to Week 48', 'timeFrame': 'Baseline to Week 48', 'description': 'Mean change in BMD (g/cm²) at lumbar spine (L1-L4) and left hip measured by dual-energy X-ray absorptiometry (DXA) in human immunodeficiency virus-infected adults with hip or spine T-score between \\< -1.0 and \\>-2.5'}], 'secondaryOutcomes': [{'measure': 'Proportion of Patients Free of Virologic Failure (Confirmed Viral Load≥ 50 Copies/mL)', 'timeFrame': '48 weeks'}, {'measure': 'Proportion of Patients With Adverse Effects', 'timeFrame': '48 weeks'}, {'measure': 'Bone Turnover Markers in Blood: Urinary N-terminal Telopeptide of Type-1 Collagen', 'timeFrame': '48 weeks'}, {'measure': 'Bone Turnover Markers in Blood: Bone-specific Alkaline Phosphatase', 'timeFrame': '48 weeks'}, {'measure': 'Renald Disfunction Parameter: Estimated Glomerular Filtration Rate', 'timeFrame': '48 weeks'}, {'measure': 'Renald Disfunction Parameter: Phosphorus in Blood Sample', 'timeFrame': '48 weeks'}, {'measure': 'Renald Disfunction, Tubule Dysfunction, Parameter: Glucose in Urine', 'timeFrame': '48 weeks'}, {'measure': 'Renald Disfunction, Tubule Dysfunction, Parameter: Protein in Urine Samples', 'timeFrame': '48 weeks'}, {'measure': 'Renald Disfunction, Tubule Dysfunction, Parameter: Albumin in Urine Samples', 'timeFrame': '48 weeks'}, {'measure': 'Renald Disfunction, Tubule Dysfunction, Parameter: Creatinin in Urine Samples', 'timeFrame': '48 weeks'}, {'measure': 'Renald Disfunction, Tubule Dysfunction, Parameter: Phosphorus in Urine Samples', 'timeFrame': '48 weeks'}, {'measure': 'Renald Disfunction, Tubule Dysfunction, Parameter: Beta-2 Microglobulin in Urine Samples', 'timeFrame': '48 weeks'}, {'measure': 'Renald Disfunction, Tubule Dysfunction, Parameter: N-Acetyl-β-D Glucosaminidase in Urine Samples', 'timeFrame': '48 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Human Immunodeficiency Virus']}, 'descriptionModule': {'briefSummary': 'A 48-week, open label, non comparative prospective trial in stable chronic human immunodeficiency virus-infected patients having achieved complete virological suppression for more than 24 weeks (human immunodeficiency virus-1 RNA \\<50 c/ml) switching from an antiretroviral regimen containing tenofovir and lamivudine or emtricitabine and boosted protease inhibitor to boosted atazanavir and lamivudine Study visits will take place at screening, baseline, weeks 4, 12, 24, and 48.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Human immunodeficiency virus-1-infected subjects with age ≥18 years old\n* Hip or spine T-scores between \\< -1.0 and \\>-2.5 by dual-energy X-ray absorptiometry (in the previous 24 weeks)\n* Stable antiretroviral treatment based on tenofovir and lamivudine or emtricitabine and boosted protease inhibitor for at least 24 weeks.\n* Having plasma human immunodeficiency virus-1 RNA \\<50 copies/mL for at least the previous 24 weeks, including at least two samples.\n\nExclusion Criteria:\n\n* Pregnancy, breast-feeding status or plans for pregnancy in the short term\n* Primary genotypic resistance mutations and/or previous virological failures to atazanavir or lamivudine/emtricitabine\n* Chronic hepatitis B infection\n* Patients with indication for therapy for the prevention of bone fractures\n* 25-OH vitamin D deficiency (\\< 10ng/mL)\n* Hypogonadism (low total testosterone according to local reference range)\n* Hypothyroidism (low T4 and increased thyroid stimulating hormone levels according to local reference ranges)\n* Hyperparathyroidism (increased parathyroid hormone level with hypercalcaemia according to local reference ranges)\n* Having received oral corticosteroids or inhaled fluticasone (daily doses higher than 5 mg/d prednisone equivalent for 3 months or more)\n* Using anti-resorptive therapy (Calcium and vitamin D supplements are encouraged but not mandated)\n* Body mass index lower than 19'}, 'identificationModule': {'nctId': 'NCT02652793', 'briefTitle': 'Simplification From Tenofovir Plus Lamivudine or Emtricitabine Plus Ritonavir-Boosted-Protease Inhibitor to Ritonavir-Boosted-Atazanavir Plus Lamivudine in Virologically-Suppressed-HIVInfected Adults With Osteopenia', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Clinic of Barcelona'}, 'officialTitle': 'Simplification From Tenofovir Plus Lamivudine or Emtricitabine Plus Ritonavir-Boosted-Protease Inhibitor to Ritonavir-Boosted-Atazanavir Plus Lamivudine in Virologically-Suppressed-HIVInfected Adults With Osteopenia', 'orgStudyIdInfo': {'id': 'Osteosimply014'}, 'secondaryIdInfos': [{'id': '2014-002720-27', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'All participants will switch their current antiretroviral regimen to a boosted atazanavir and lamivudine once daily.', 'interventionNames': ['Drug: Boosted atazanavir', 'Drug: Lamivudine']}], 'interventions': [{'name': 'Boosted atazanavir', 'type': 'DRUG', 'description': 'Atanazir 300 mg once dailly boosted with 100 mg of ritonavir once dailly', 'armGroupLabels': ['Experimental']}, {'name': 'Lamivudine', 'type': 'DRUG', 'description': 'Lamivudine 300 mg once dailly', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clínic i Provincial de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Judit Pich', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundacion Clinic per a la Recerca Biomédica', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Research Manager', 'investigatorFullName': 'Judit Pich', 'investigatorAffiliation': 'Hospital Clinic of Barcelona'}}}}