Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:37 PM
Study NCT ID:
NCT01093651
Status:
COMPLETED
Last Update Posted:
2014-02-17
First Post:
2010-03-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Dipeptidyl Peptidase-4 Inhibition and Immune Function in HIV
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068900', 'term': 'Sitagliptin Phosphate'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011719', 'term': 'Pyrazines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'key@wustl.edu', 'phone': '3143628173', 'title': 'Kevin Yarasheski, PhD', 'organization': 'Washington Univ Med Sch'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Potential for type 2 error given small sample size. But, study was powered to detect significant decline in CD4 count. Measures of monocyte and lymphocyte activation should be conducted.'}}, 'adverseEventsModule': {'timeFrame': '16 weeks', 'description': 'SAE or AE Any self reported symptom that was graded greater than 2 on the DAIDS severity scale during the 16 week period. These were reported as a serious or adverse event or toxicity.\n\nOther adverse event: Any self-reported symptom that was graded less than or equal to 2 (DAIDS scale) during the 16 week period;these are not serious adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count \\>350 cells/µL) and virologic (plasma HIV RNA \\<50 copies/mL) status.\n\nPlacebo : Daily placebo for 4 months', 'otherNumAtRisk': 10, 'otherNumAffected': 7, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'DPPIV Inhibition', 'description': 'Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count \\>350 cells/µL) and virologic (plasma HIV RNA \\<50 copies/mL) status.\n\nSitagliptin : 100 mg sitagliptin daily for 4 months', 'otherNumAtRisk': 10, 'otherNumAffected': 6, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hypoglycemia symptoms', 'notes': 'Not SAE; severity graded less than 2 on DAIDS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal symptoms', 'notes': 'Not SAE; severity graded less than 2 on DAIDS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory symptoms', 'notes': 'Not SAE; severity graded less than 2 on DAIDS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 10, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Generalized fatigue', 'notes': 'Not SAE; severity graded less than 2 on DAIDS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'notes': 'Not SAE; severity graded less than 2 on DAIDS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'notes': 'Not SAE; severity graded less than 2 on DAIDS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle pain', 'notes': 'Not SAE; severity graded less than 2 on DAIDS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Mood change', 'notes': 'Not SAE; severity graded less than 2 on DAIDS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'CD4+ T-cell Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count \\>350 cells/µL) and virologic (plasma HIV RNA \\<50 copies/mL) status.\n\nPlacebo : Daily placebo for 4 months'}, {'id': 'OG001', 'title': 'DPPIV Inhibition', 'description': 'Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count \\>350 cells/µL) and virologic (plasma HIV RNA \\<50 copies/mL) status.\n\nSitagliptin : 100 mg sitagliptin daily for 4 months'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '602', 'spread': '91', 'groupId': 'OG000'}, {'value': '648', 'spread': '185', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '689', 'spread': '153', 'groupId': 'OG000'}, {'value': '750', 'spread': '225', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '696', 'spread': '194', 'groupId': 'OG000'}, {'value': '656', 'spread': '207', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '686', 'spread': '167', 'groupId': 'OG000'}, {'value': '706', 'spread': '168', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '681', 'spread': '151', 'groupId': 'OG000'}, {'value': '636', 'spread': '173', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'The a priori threshold for statistical significance was p\\<0.05. The main effect analysis for CD4+ T-cell count over time and between the 2 groups did not achieve p\\<0.05 (not statistically significant).', 'groupDescription': 'The main effect analysis was applied to both rows (timepoint) and categories (groups). It used linear mixed models to simultaneously assess differences in CD4+ T-cell count between the DPP4 inhibitor and placebo groups (categories) over time (rows). Pairwise post-hoc contrasts were performed to assess the between and within group differences in outcome measures at each time point.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Study subject was included in these models as a random variable to account for within-participant correlation.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Monthly for 4 months', 'unitOfMeasure': 'cells/µL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'CD4+ T-cell count'}, {'type': 'PRIMARY', 'title': 'Plasma HIV Viremia (Viral Load)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count \\>350 cells/µL) and virologic (plasma HIV RNA \\<50 copies/mL) status.\n\nPlacebo : Daily placebo for 4 months'}, {'id': 'OG001', 'title': 'DPPIV Inhibition', 'description': 'Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count \\>350 cells/µL) and virologic (plasma HIV RNA \\<50 copies/mL) status.\n\nSitagliptin : 100 mg sitagliptin daily for 4 months'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'The a priori threshold for statistical significance was p\\<0.05. The main effect analysis for plasma HIV RNA copy number/mL over time and between the 2 groups did not achieve p\\<0.05 (not statistically significant).', 'groupDescription': 'The main effect analysis was applied to both rows (timepoint) and categories (groups). It used linear mixed models to simultaneously assess differences in plasma HIV RNA copy number/mL between the DPP4 inhibitor and placebo groups (categories) over time (rows). Pairwise post-hoc contrasts were performed to assess the between and within group differences in outcome measures at each time point.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Monthly for 6 months', 'description': 'Percentage of participants with plasma HIV RNA copy number less than 48 copies/mL', 'unitOfMeasure': 'percentage of participants below 48 c/mL', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Soluble TNFR2; Serum Biomarkers of Immune Activation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count \\>350 cells/µL) and virologic (plasma HIV RNA \\<50 copies/mL) status.\n\nPlacebo : Daily placebo for 4 months'}, {'id': 'OG001', 'title': 'DPPIV Inhibition', 'description': 'Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count \\>350 cells/µL) and virologic (plasma HIV RNA \\<50 copies/mL) status.\n\nSitagliptin : 100 mg sitagliptin daily for 4 months'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2220', 'spread': '389', 'groupId': 'OG000'}, {'value': '2436', 'spread': '431', 'groupId': 'OG001'}]}]}, {'title': 'week 8', 'categories': [{'measurements': [{'value': '2218', 'spread': '411', 'groupId': 'OG000'}, {'value': '2617', 'spread': '638', 'groupId': 'OG001'}]}]}, {'title': 'week 16', 'categories': [{'measurements': [{'value': '2279', 'spread': '415', 'groupId': 'OG000'}, {'value': '2388', 'spread': '449', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'The a priori threshold for statistical significance was p\\<0.05. The main effect analysis for serum TNFR2 levels over time and between the 2 groups did not achieve p\\<0.05 (not statistically significant).', 'groupDescription': 'The main effect analysis was applied to both rows (timepoint) and categories (groups). It used linear mixed models to simultaneously assess differences in serum TNFR2 levels between the DPP4 inhibitor and placebo groups (categories) over time (rows). Pairwise post-hoc contrasts were performed to assess the between and within group differences in outcome measures at each time point.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 8, week 16', 'description': 'serum soluble tumor necrosis factor receptor-2 concentration', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'sTNFR2'}, {'type': 'SECONDARY', 'title': 'SDF1α; Serum Biomarkers of Immune Activation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count \\>350 cells/µL) and virologic (plasma HIV RNA \\<50 copies/mL) status.\n\nPlacebo : Daily placebo for 4 months'}, {'id': 'OG001', 'title': 'DPPIV Inhibition', 'description': 'Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count \\>350 cells/µL) and virologic (plasma HIV RNA \\<50 copies/mL) status.\n\nSitagliptin : 100 mg sitagliptin daily for 4 months'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2327', 'spread': '304', 'groupId': 'OG000'}, {'value': '2378', 'spread': '441', 'groupId': 'OG001'}]}]}, {'title': 'week 8', 'categories': [{'measurements': [{'value': '2313', 'spread': '364', 'groupId': 'OG000'}, {'value': '1208', 'spread': '605', 'groupId': 'OG001'}]}]}, {'title': 'week 16', 'categories': [{'measurements': [{'value': '2309', 'spread': '400', 'groupId': 'OG000'}, {'value': '1277', 'spread': '490', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0002', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'The a priori threshold for statistical significance was p\\<0.05. The main effect analysis for SDF1-alpha levels over time and between the 2 groups achieved p\\<0.0002.', 'groupDescription': 'The main effect analysis was applied to both rows (timepoint) and categories (groups). It used linear mixed models to simultaneously assess differences in serum SDF1α levels between the DPP4 inhibitor and placebo groups (categories) over time (rows). Pairwise post-hoc contrasts were performed to assess the between and within group differences in outcome measures at each time point.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 8, week 16', 'description': 'serum stromal cell-derived factor-1α concentration', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SDF1α'}, {'type': 'SECONDARY', 'title': 'RANTES; Serum Biomarkers of Immune Activation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count \\>350 cells/µL) and virologic (plasma HIV RNA \\<50 copies/mL) status.\n\nPlacebo : Daily placebo for 4 months'}, {'id': 'OG001', 'title': 'DPPIV Inhibition', 'description': 'Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count \\>350 cells/µL) and virologic (plasma HIV RNA \\<50 copies/mL) status.\n\nSitagliptin : 100 mg sitagliptin daily for 4 months'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '80.8', 'spread': '23.2', 'groupId': 'OG000'}, {'value': '64.4', 'spread': '37.2', 'groupId': 'OG001'}]}]}, {'title': 'week 8', 'categories': [{'measurements': [{'value': '85.3', 'spread': '27.7', 'groupId': 'OG000'}, {'value': '68.5', 'spread': '43.0', 'groupId': 'OG001'}]}]}, {'title': 'week 16', 'categories': [{'measurements': [{'value': '74.9', 'spread': '27.8', 'groupId': 'OG000'}, {'value': '62.8', 'spread': '32.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'The a priori threshold for statistical significance was p\\<0.05. The main effect analysis for serum RANTES levels over time and between the 2 groups did not achieve p\\<0.05 (not statistically significant).', 'groupDescription': 'The main effect analysis was applied to both rows (timepoint) and categories (groups). It used linear mixed models to simultaneously assess differences in serum RANTES levels between the DPP4 inhibitor and placebo groups (categories) over time (rows). Pairwise post-hoc contrasts were performed to assess the between and within group differences in outcome measures at each time point.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 8, week 16', 'description': 'serum Regulated on Activation, Normal T cell Expressed and Secreted concentration', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'RANTES'}, {'type': 'SECONDARY', 'title': 'Oral Glucose Tolerance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count \\>350 cells/µL) and virologic (plasma HIV RNA \\<50 copies/mL) status.\n\nPlacebo : Daily placebo for 4 months'}, {'id': 'OG001', 'title': 'DPPIV Inhibition', 'description': 'Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count \\>350 cells/µL) and virologic (plasma HIV RNA \\<50 copies/mL) status.\n\nSitagliptin : 100 mg sitagliptin daily for 4 months'}], 'classes': [{'title': 'Baseline AUCg', 'categories': [{'measurements': [{'value': '142.5', 'spread': '26.6', 'groupId': 'OG000'}, {'value': '145.6', 'spread': '32.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 AUCg', 'categories': [{'measurements': [{'value': '158.0', 'spread': '26.7', 'groupId': 'OG000'}, {'value': '133.6', 'spread': '24.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 AUCg', 'categories': [{'measurements': [{'value': '157.5', 'spread': '23.2', 'groupId': 'OG000'}, {'value': '142.5', 'spread': '21.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.04', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'The a priori threshold for statistical significance was p\\<0.05. The main effect analysis for area under the glucose tolerance curve over time and between the 2 groups achieved p\\<0.04.', 'groupDescription': 'The main effect analysis was applied to both rows (timepoint) and categories (groups). It used linear mixed models to simultaneously assess differences in area under the glucose tolerance curves between the DPP4 inhibitor and placebo groups (categories) over time (rows). Pairwise post-hoc contrasts were performed to assess the between and within group differences in outcome measures at each time point.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 8, week 16', 'description': 'Area under the 75-gr oral glucose tolerance curve (AUCg) based on plasma glucose values measured at 0, 30, 60, 90, and 120 mins post-glucose challenge.', 'unitOfMeasure': 'mg*min/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Self-reported Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count \\>350 cells/µL) and virologic (plasma HIV RNA \\<50 copies/mL) status.\n\nPlacebo : Daily placebo for 4 months'}, {'id': 'OG001', 'title': 'DPPIV Inhibition', 'description': 'Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count \\>350 cells/µL) and virologic (plasma HIV RNA \\<50 copies/mL) status.\n\nSitagliptin : 100 mg sitagliptin daily for 4 months'}], 'classes': [{'title': 'Hypoglycemia symptoms', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'GI symptoms', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Upper respiratory symptoms', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Generalized fatigue', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Other (e.g., rash, muscle pain, mood change)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'The a priori threshold for statistical significance was p\\<0.05. The non-paramteric test for adverse event cummulative frequency between the 2 groups did not achieve p\\<0.05 (not statistically significant)', 'groupDescription': 'Kruskal-Wallis non-parametric test of cell frequencies', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Monthly for 4 months', 'description': 'Cumulative number of self-reported symptoms based on the Division of AIDS Grading Scale for the Severity of Adult Adverse Events (0-4 scale where 0 is no new symptoms, 4 is serious adverse event or toxicity)', 'unitOfMeasure': 'total number of self reported symptoms', 'reportingStatus': 'POSTED', 'populationDescription': 'Cumulative frequency over 16 weeks of any self-reported symptoms on the DAIDS scale'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count \\>350 cells/µL) and virologic (plasma HIV RNA \\<50 copies/mL) status.\n\nPlacebo : Daily placebo for 4 months'}, {'id': 'FG001', 'title': 'DPPIV Inhibition', 'description': 'Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count \\>350 cells/µL) and virologic (plasma HIV RNA \\<50 copies/mL) status.\n\nSitagliptin : 100 mg sitagliptin daily for 4 months'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'HIV-infected adults (18 - 65 years old) were recruited from the AIDS Clinical Trials Unit and the Infectious Diseases Clinic at Washington University School of Medicine. Thirty-one candidates were screened and 20 were enrolled; all participants were HIV positive but were otherwise healthy with stable immunologic and virologic status on HAART.', 'preAssignmentDetails': 'Twenty participants were randomized to n=10 placebo or n=10 sitagliptin (Januvia(R)). Eleven volunteers were screened and found ineligible (see eligibility criteria), or did not choose to participate in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count \\>350 cells/µL) and virologic (plasma HIV RNA \\<50 copies/mL) status.\n\nPlacebo : Daily placebo for 4 months'}, {'id': 'BG001', 'title': 'DPPIV Inhibition', 'description': 'Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count \\>350 cells/µL) and virologic (plasma HIV RNA \\<50 copies/mL) status.\n\nSitagliptin : 100 mg sitagliptin daily for 4 months'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40', 'spread': '15', 'groupId': 'BG000'}, {'value': '36', 'spread': '9', 'groupId': 'BG001'}, {'value': '38', 'spread': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-22', 'studyFirstSubmitDate': '2010-03-23', 'resultsFirstSubmitDate': '2013-05-13', 'studyFirstSubmitQcDate': '2010-03-24', 'lastUpdatePostDateStruct': {'date': '2014-02-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-12-17', 'studyFirstPostDateStruct': {'date': '2010-03-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CD4+ T-cell Count', 'timeFrame': 'Monthly for 4 months'}, {'measure': 'Plasma HIV Viremia (Viral Load)', 'timeFrame': 'Monthly for 6 months', 'description': 'Percentage of participants with plasma HIV RNA copy number less than 48 copies/mL'}], 'secondaryOutcomes': [{'measure': 'Soluble TNFR2; Serum Biomarkers of Immune Activation', 'timeFrame': 'Baseline, week 8, week 16', 'description': 'serum soluble tumor necrosis factor receptor-2 concentration'}, {'measure': 'SDF1α; Serum Biomarkers of Immune Activation', 'timeFrame': 'Baseline, week 8, week 16', 'description': 'serum stromal cell-derived factor-1α concentration'}, {'measure': 'RANTES; Serum Biomarkers of Immune Activation', 'timeFrame': 'Baseline, week 8, week 16', 'description': 'serum Regulated on Activation, Normal T cell Expressed and Secreted concentration'}, {'measure': 'Oral Glucose Tolerance', 'timeFrame': 'Baseline, week 8, week 16', 'description': 'Area under the 75-gr oral glucose tolerance curve (AUCg) based on plasma glucose values measured at 0, 30, 60, 90, and 120 mins post-glucose challenge.'}, {'measure': 'Self-reported Symptoms', 'timeFrame': 'Monthly for 4 months', 'description': 'Cumulative number of self-reported symptoms based on the Division of AIDS Grading Scale for the Severity of Adult Adverse Events (0-4 scale where 0 is no new symptoms, 4 is serious adverse event or toxicity)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Diabetes', 'Insulin Resistance']}, 'referencesModule': {'references': [{'pmid': '23264399', 'type': 'RESULT', 'citation': 'Goodwin SR, Reeds DN, Royal M, Struthers H, Laciny E, Yarasheski KE. Dipeptidyl peptidase IV inhibition does not adversely affect immune or virological status in HIV infected men and women: a pilot safety study. J Clin Endocrinol Metab. 2013 Feb;98(2):743-51. doi: 10.1210/jc.2012-3532. Epub 2012 Dec 21.'}]}, 'descriptionModule': {'briefSummary': 'We will test the safety of a new class of anti-diabetes compounds (DPPIV-inhibitors) in people living with HIV. Future trials will examine efficacy for treating diabetes and reducing cardiovascular disease risk in people living with HIV.', 'detailedDescription': 'Human immunodeficiency virus (HIV)-infection and treatment with antiretroviral therapies are associated with several cardiometabolic risk factors; insulin resistance, diabetes, dyslipidemia, central adiposity, that increase risk for MI and stroke. A new class of drugs used to treat type 2 diabetes has been introduced; Dipeptidyl peptidase-IV (DPPIV)-inhibitors (Januvia®, Onglyza®, alogliptin). Dipeptidyl peptidase-IV (DPPIV)-inhibition could be a safe and effective therapy for HIV-associated insulin resistance and diabetes. However, no safety data exist. The research question is: If HIV+ adults with stable immunologic (CD4+ T-cell count \\>350 cells/μL) and virologic (plasma HIV RNA \\<50 copies/mL) function are given a DPPIV-inhibitor would their CD4+ T-cell count and plasma HIV RNA level increase, decrease, or stay the same? Theoretically, DPPIV-inhibition could enhance their immune system by increasing SDF-1α levels; a potent inhibitor of HIV-entry into T-cells, or harm the HIV+ immune system by inactivating CD26 on immune cells. We hypothesize that DPPIV-inhibition will not harm the immune system in HIV+ people. We propose a blinded randomized controlled pilot safety trial of an FDA-approved DPPIV-inhibitor in virologically- and immunologically-stable HIV+ men and women. We will monitor CD4+ T-cell count, plasma HIV RNA levels, immune activation markers, and safety outcomes (lipid/lipoprotein profiles, blood pressure, kidney and liver function) during 4-6 months of DPPIV-inhibitor exposure vs placebo in 20 HIV+ adults. If safety is confirmed, the efficacy of DPPIV-inhibition in HIV+ with insulin resistance will be tested in future trials that examine potential glucoregulatory and cardiovascular benefits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Thirty 18-65 yr old HIV-infected men and women (with source documentation of HIV status) who are stable on any antiretroviral therapy (cART) regimen\n2. Have stable (at least the past 12-months) immunologic (\\>350 CD4+ T-cells/µL) and virologic (\\<50 copies HIV RNA/mL) status.\n3. BMI 18-42kg/m2;\n4. Normal blood chemistry for at least 1 month prior to enrollment;\n5. Platelet count \\> 30,000/mm3, absolute neutrophil count \\>750/mm3, transaminases \\< 2.5x the upper limit of normal (ULN).\n6. Long-term non-progressors (not on ART) are not eligible.\n\nExclusion Criteria:\n\n1. CD4+ T-cell count \\<350 cells/µL or detectable plasma HIV RNA (\\>50 copies HIV RNA/mL) within the past 12-months. During the study, if CD4+ T-cell count declines by \\>100 cells/µL, or if plasma HIV RNA becomes detectable (\\>50 copies HIV RNA/mL after repeat analysis 2wks apart), and the participant denies any lapse in their anti-HIV medication regimen, the study medication will be stopped and an adverse event documented. If at any time during the study, two participants experience a reduction in T-cell count \\>100 cells/µL, or their plasma HIV RNA levels become detectable (\\>50 copies HIV RNA/mL after repeat analysis 2wks apart), and they are confirmed (by unblinding) to have received sitagliptin, the study will be stopped for serious safety concerns.\n2. Systemic, secondary or opportunistic infection within past 12-months.\n3. Fasting glucose intolerance (FBG \\>100mg/dL), fasting hyperinsulinemia (\\>15µU/mL), or fasting insulin resistance (Homeostasis model for insulin resistance (HOMA) \\>3.0). Any agents that might alter glucose metabolism (insulin, TZDs, metformin, glucocorticoids, sulfonylurea, corticosteroids, megace, rhGH, GH-secretagogue) during the 3 months prior to enrollment or at any time during enrollment. Volunteers with T2DM, IDDM or diabetic ketoacidosis will not be enrolled.\n4. History of serious CV disease or NYHA Functional Class III or IV, (e.g., recent MI, unstable angina, edema, CHF, CAD, CABG, valve disease (murmur), stroke, uncontrolled high blood pressure (resting \\>160/95 mmHg), irregular heart rhythm, resting ST-segment depression \\>1mm). Treatment with medications for a CV condition (cardiac glycosides α- or ß-blockers). Some antihypertensive medications (calcium-channel blocker, diuretic, angiotensin II receptor blockers (ARB), angiotensin converting enzyme inhibitors (ACE)) will be permitted.\n5. Moderate to severe renal insufficiency. Serum creatinine \\>1.7 mg/dL (men) \\>1.5 mg/dL (women).\n6. Known allergy or hypersensitivity to DPPIV-inhibitors.\n7. Plan to change anti-HIV medication regimen or prophylaxis for opportunistic infection within 6-months of starting study.Transitions among efavirenz-based regimens will be allowed (e.g., Efavirenz + lamivudine + zidovudine (combivir) to Efavirenz + emtricitabine + tenofovir (Atripla)).\n8. Lipid-lowering medications are permitted (fibrate or statin or niacin), but must be stable on that agent for at least 3 months prior to enrollment. Lipid-lowering agents cannot be started during the treatment period.\n9. Chronic hepatitis B infection (HB surface antigen positive). Active hepatitis C infection (detectable Hep C RNA). Those who have cleared hepatitis B or C infection are eligible.\n10. Hematocrit \\<34% in men or \\<25% in women with symptoms (fatigue, "tired-legs", shortness of breath). Hemoglobin \\<10 gm/100ml with symptoms.\n11. Nausea, vomiting, diarrhea (\\>4 loose stools/day) that are unresponsive to treatment. History of eating disorder or significant GI-disease.\n12. Pregnant or nursing mothers. Women must agree to use an acceptable form of birth control during the study. If birth control pills are used, the woman must be stable on these medications for at least 6 months prior to enrollment.\n13. Active malignancy or treatment with chemotherapeutic agents or radiation therapy (within past 12 months).\n14. \\>10% unintentional body weight loss during the 12 months prior to enrollment.\n15. "Blinded" investigational drugs/medications during the 3 months prior to enrollment that will not be unblinded before enrollment. Open-label investigational drugs are permitted (within past 3 months, no plan to stop during enrollment and not known to affect glucose, lipid, adipose tissue or liver metabolism).\n16. Over the counter agents that might alter glucose, lipid, or adipose tissue metabolism (e.g., creatine monohydrate, chromium picolinate, amino acid/protein supplements, medium- or long-chain fatty acids) within 1 month of enrollment. These supplements are not permitted during the treatment period.\n17. Reduced cognitive function/unable to provide voluntary informed consent. Prisoners are excluded.\n18. Active substance abuse that the physician-scientist believes may compromise safety, compliance, or interfere with study drug or data interpretation.\n19. Any cytokine or anti-cytokine therapy during 3 months prior to enrollment.'}, 'identificationModule': {'nctId': 'NCT01093651', 'acronym': 'DPPIVinHIV', 'briefTitle': 'Dipeptidyl Peptidase-4 Inhibition and Immune Function in HIV', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'A Blinded Randomized Controlled Pilot Immunologic and Virologic Safety Trial of an FDA-approved DPPIV-inhibitor in HIV+ Men and Women', 'orgStudyIdInfo': {'id': 'KEY03222010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DPPIV inhibition', 'description': 'Four to six months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count \\>350 cells/µL) and virologic (plasma HIV RNA \\<50 copies/mL) status.', 'interventionNames': ['Drug: Sitagliptin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Four to six months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count \\>350 cells/µL) and virologic (plasma HIV RNA \\<50 copies/mL) status.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Sitagliptin', 'type': 'DRUG', 'description': '100 mg sitagliptin daily for 4-6 months', 'armGroupLabels': ['DPPIV inhibition']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Daily placebo for 4-6 months', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Kevin E Yarasheski, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Campbell Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Kevin Yarasheski, PhD', 'investigatorAffiliation': 'Washington University School of Medicine'}}}}