Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2026-02-07 @ 10:11 PM
Study NCT ID:
NCT01744093
Status:
COMPLETED
Last Update Posted:
2022-07-21
First Post:
2012-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Doxycycline for COPD in HIV-Infected Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D004646', 'term': 'Emphysema'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004318', 'term': 'Doxycycline'}, {'id': 'D000073893', 'term': 'Sugars'}], 'ancestors': [{'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mew2001@med.cornell.edu', 'phone': '646-962-2672', 'title': 'Mei Wang, BS, CCRP', 'organization': 'Weill Cornell Medicine'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '24 Weeks', 'description': 'Clinical assessments included full physical examination at screening, targeted physical examinations at other visits, ongoing assessments for adverse events and new clinical diagnoses and CAT review at each visit. Safety labs were obtained at weeks 2, 6, 12, 18, and 24. 2 participants in the doxycycline arm and 1 participant in the placebo arm were not evaluated for adverse events because they did not take the study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Doxycycline', 'description': 'Doxycycline x 100 mg BID (orally) for 24 weeks.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 13, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo (Sugar Pill)', 'description': 'Placebo (sugar pill) x 100 mg BID (orally) for 24 weeks.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 6, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Oral thrush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemoglobin drop', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mouth lesions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Excoriated lesions on arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intermittent diarrhea for 4-5 wk', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Scattered maculopapular rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemoptysis (mild)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Low absolute neutrophil count', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain on right side', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tiredness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Elevated Creatinine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Safety of Doxycycline, as Measured by the Number of Subjects With Any Treatment-related Adverse Events.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Doxycycline', 'description': 'Doxycycline x 100 mg BID (orally) for 24 weeks'}, {'id': 'OG001', 'title': 'Placebo (Sugar Pill)', 'description': 'Placebo (sugar pill) x 100 mg BID (orally) for 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Proportion (percent)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.8', 'ciLowerLimit': '4.0', 'ciUpperLimit': '45.6', 'estimateComment': 'Exact two-sided 95% Clopper-Pearson confidence interval.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive proportion'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 24 weeks', 'description': 'To determine the safety of twice daily doxycycline for 24 weeks in HIV-infected subjects with COPD and/or emphysema as measured by the number of subjects with any treatment-related adverse events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '2 subjects were randomized to the doxycycline arm, but withdrew prior to starting the study drug. 1 subject was randomized to the placebo arm, but withdrew prior to starting the study drug.'}, {'type': 'PRIMARY', 'title': 'Tolerability of Doxycycline, as Measured by the Number of Subjects With a Dose-limiting Toxicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Doxycycline', 'description': '100 mg twice daily (BID orally) x 24 weeks\n\nDoxycycline: 100 mg twice daily (BID orally) x 24 weeks'}, {'id': 'OG001', 'title': 'Placebo (Sugar Pill)', 'description': '100 mg twice daily (BID orally) x 24 weeks\n\nPlacebo (sugar pill): 100 mg twice daily (BID orally) x 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000'], 'paramType': 'Proportion (percent)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.3', 'ciLowerLimit': '0.16', 'ciUpperLimit': '30.2', 'estimateComment': 'Exact two-sided 95% Clopper-Pearson confidence interval.', 'groupDescription': 'Null hypothesis adverse event rate (grade 2 or higher toxicity) = 45.5%', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 24 weeks', 'description': 'To determine the tolerability of twice daily doxycycline for 24 weeks in HIV-infected subjects with COPD and/or emphysema as measured by those subjects experiencing a dose-limiting toxicity', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '2 subjects were randomized to the doxycycline arm, but withdrew prior to starting the study drug. 1 subject was randomized to the placebo arm, but withdrew prior to starting the study drug.'}, {'type': 'SECONDARY', 'title': 'Clinical: Change in Pulmonary Function (FEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Doxycycline', 'description': '100 mg twice daily (BID orally) x 24 weeks\n\nDoxycycline: 100 mg twice daily (BID orally) x 24 Weeks'}, {'id': 'OG001', 'title': 'Placebo (Sugar Pill)', 'description': 'One pill twice daily (BID orally) x 24 Weeks\n\nPlacebo (sugar pill): One pill twice daily (BID orally) x 24 Weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.5', 'groupId': 'OG000', 'lowerLimit': '-4.5', 'upperLimit': '2.25'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '-1.75', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24 Weeks', 'description': 'FEV1 is the volume of air exhaled during the first second of a forced expiratory maneuver.', 'unitOfMeasure': 'Percentage of predicted FEV1', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'At 24 Weeks, total 7 subjects were not analyzed at Week 24. With arm-Doxycycline, 6 subjects dropped out; with arm-Placebo, 1 subject dropped out.'}, {'type': 'SECONDARY', 'title': 'Percent Change in BAL MMP-9 Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Doxycycline', 'description': '100 mg twice daily (BID orally) x 24 Weeks'}, {'id': 'OG001', 'title': 'Placebo (Sugar Pill)', 'description': 'One pill twice daily (BID orally) x 24 Weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-42', 'groupId': 'OG000', 'lowerLimit': '-62', 'upperLimit': '-28'}, {'value': '21', 'groupId': 'OG001', 'lowerLimit': '-23', 'upperLimit': '93'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 Weeks', 'description': 'Percent change of MMP-9 activity in bronchoalveolar lavage (BAL) fluid.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'With arm-Doxy, 8 subjects were not analyzed at Week 12 because 5 subjects dropped out, 2 subjects had an inadequate sample, 1 subject could not have the bronchoscopy. With arm-Placebo, 2 subjects were not analyzed at Week 12 because 1 subject dropped out and 1 subject could not have the bronchoscopy.'}, {'type': 'SECONDARY', 'title': 'Doxycycline Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Doxycycline', 'description': '100 mg twice daily (BID orally) x 24 Weeks\n\nDoxycycline: 100 mg twice daily (BID orally) x 24 Weeks'}, {'id': 'OG001', 'title': 'Placebo (Sugar Pill)', 'description': 'One pill (BID orally) x 24 Weeks\n\nPlacebo (sugar pill): One pill twice daily (BID orally) x 24 Weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '3005', 'groupId': 'OG000', 'lowerLimit': '2684', 'upperLimit': '4179'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 Weeks', 'description': 'Doxycycline level in serum', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'With arm-Doxy, 6 subjects were not analyzed at Week 12 because 5 subjects dropped out, 1 subject did not provide a sample. With arm-Placebo, 2 subjects were not analyzed at Week 12 because 1 subject dropped out and 1 subject did not provide a sample.'}, {'type': 'SECONDARY', 'title': 'Doxycycline Levels in BAL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Doxycycline', 'description': '100 mg twice daily (BID orally) x 24 Weeks\n\nDoxycycline: 100 mg twice daily (BID orally) x 24 Weeks'}, {'id': 'OG001', 'title': 'Placebo (Sugar Pill)', 'description': 'One pill (BID orally) x 24 Weeks\n\nPlacebo (sugar pill): One pill twice daily (BID orally) x 24 Weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '16.75', 'groupId': 'OG000', 'lowerLimit': '10.88', 'upperLimit': '22.15'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '00', 'upperLimit': '00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 Week', 'description': 'Doxycycline levels in bronchoalveolar lavage (BAL) fluid.', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'With arm-Doxy, 6 subjects were not analyzed at Week 12 because 5 subjects dropped out, 1 subject could not have the bronchoscopy. With arm-Placebo, 2 subjects were not analyzed at Week 12 because 1 subject dropped out and 1 subject could not have the bronchoscopy.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Doxycycline', 'description': 'Doxycycline x 100 mg twice daily (BID orally) for 24 weeks'}, {'id': 'FG001', 'title': 'Placebo (Sugar Pill)', 'description': 'One pill twice daily (BID orally) for 24 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Of the 61 subjects enrolled into the study, 34 subjects did not pass screening.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Doxycycline', 'description': 'Doxycycline x 100 mg BID (orally) for 24 weeks'}, {'id': 'BG001', 'title': 'Placebo (Sugar Pill)', 'description': 'Placebo (sugar pill) x 100 mg BID (orally) for 24 weeks'}, {'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': '18', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '27', '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': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', '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': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-05-15', 'size': 772010, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-08-31T15:27', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-13', 'studyFirstSubmitDate': '2012-11-20', 'resultsFirstSubmitDate': '2018-08-31', 'studyFirstSubmitQcDate': '2012-12-04', 'lastUpdatePostDateStruct': {'date': '2022-07-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-10-08', 'studyFirstPostDateStruct': {'date': '2012-12-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of Doxycycline, as Measured by the Number of Subjects With Any Treatment-related Adverse Events.', 'timeFrame': 'Up to 24 weeks', 'description': 'To determine the safety of twice daily doxycycline for 24 weeks in HIV-infected subjects with COPD and/or emphysema as measured by the number of subjects with any treatment-related adverse events.'}, {'measure': 'Tolerability of Doxycycline, as Measured by the Number of Subjects With a Dose-limiting Toxicity', 'timeFrame': 'Up to 24 weeks', 'description': 'To determine the tolerability of twice daily doxycycline for 24 weeks in HIV-infected subjects with COPD and/or emphysema as measured by those subjects experiencing a dose-limiting toxicity'}], 'secondaryOutcomes': [{'measure': 'Clinical: Change in Pulmonary Function (FEV1)', 'timeFrame': '24 Weeks', 'description': 'FEV1 is the volume of air exhaled during the first second of a forced expiratory maneuver.'}, {'measure': 'Percent Change in BAL MMP-9 Activity', 'timeFrame': '12 Weeks', 'description': 'Percent change of MMP-9 activity in bronchoalveolar lavage (BAL) fluid.'}, {'measure': 'Doxycycline Levels', 'timeFrame': '12 Weeks', 'description': 'Doxycycline level in serum'}, {'measure': 'Doxycycline Levels in BAL', 'timeFrame': '12 Week', 'description': 'Doxycycline levels in bronchoalveolar lavage (BAL) fluid.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV', 'COPD', 'Chronic Obstructive Pulmonary Disease', 'Emphysema'], 'conditions': ['HIV', 'Chronic Obstructive Pulmonary Disease (COPD)', 'Emphysema']}, 'descriptionModule': {'briefSummary': 'In the context of improved survival from HIV infection itself, chronic obstructive pulmonary disease (COPD); a form of lung disease that includes emphysema, which makes breathing difficult) is emerging as an important cause of morbidity and perhaps ultimately mortality in this population. HIV-infected patients are at increased risk of chronic obstructive pulmonary disease, likely due to multiple factors, including an increased presence of smoking, chronic inflammation and progression of immunodeficiency, oxidant stress (excessive levels of natural chemicals called oxidants and free radicals that can damage tissue), and respiratory infections. While natural history data on COPD are limited in the era of potent antiretroviral therapy, earlier data suggest that the course of emphysema may be accelerated in this population. Our preliminary data suggest that several matrix metalloproteinases (MMPs) derived from alveolar macrophages (a type of immune cell found in the lungs) have an increased cellular response in HIV-infected smokers, which could contribute to accelerated emphysema. Matrix metalloproteinases are enzymes that break down the structural support of tissues, including the airways in the lung.\n\nBased on these observations, the investigators hypothesize that pharmacologic inhibition of matrix metalloproteinases by doxycycline will favorably modify the natural history of chronic obstructive pulmonary disease in HIV-infected patients. To test this hypothesis, the investigators propose conducting a proof of concept pilot study as a prelude to a possible phase II randomized, placebo-controlled trial (testing safety and efficacy in a larger population controlled with a "sugar pill") of doxycycline for COPD in HIV-infected patients should the proof of concept be successful. Our research team is lead by a pulmonologist/researcher with expertise in HIV-associated COPD and an infectious diseases specialist/clinical trials expert.', 'detailedDescription': 'Chronic obstructive pulmonary disease (COPD) is emerging as an important cause of morbidity in HIV-infected patients, likely due to multiple factors, including an increased prevalence of smoking, chronic inflammation and immune activation, oxidant stress and respiratory infections. Our preliminary data suggest that several lung matrix metalloproteinases (MMPs) are upregulated in HIV-infected smokers, which could contribute to accelerated emphysema by virtue of their ability to degrade extracellular matrix and basement membrane components. Our Specific Aim is to determine the safety, tolerability, and biologic effects of twice daily doxycycline for 6 months in HIV-infected subjects with COPD. To address this aim, we will conduct a randomized, double-blind, placebo-controlled pilot study of doxycycline 100 mg twice daily in 30 HIV-infected subjects with COPD (2:1 doxy:placebo). The primary endpoint will be safety/tolerability and secondary endpoints will include change in FEV1, reduction of MMP activity in epithelial lining fluid and cells obtained by bronchoscopy and doxycycline levels in blood, ELF and bronchoalveolar lavage (BAL) cell pellets. In addition to providing novel insights into the biologic effects of doxycycline in the lung, the pilot study will inform selection of endpoints for a phase II trial, which ultimately will address an unmet medical need for novel interventions for COPD/emphysema in HIV-infected patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Documented HIV infection\n2. CD4 cell count greater than 200 cells/mm3\n3. HIV RNA less than 400 copies/ml\n4. Stable antiretroviral therapy for greater than or equal to 12 weeks\n5. Fulfills GOLD definition for COPD (post-bronchodilator FEV1/FVC less than 0.7) and/or has radiographic evidence of emphysema\n6. Current or history of smoking with minimum 3 pack-year history\n7. ALT and AST less than 3 x upper limit of normal\n8. For women of childbearing potential: willingness to use 2 forms of birth control\n9. Subjects on therapy for COPD must be on stable therapy for at least 4 weeks\n\nExclusion Criteria:\n\n1. Pulmonary infection, COPD exacerbation, or acute opportunistic infection within 30 days of entry\n2. Conditions associated with increased sedation of bronchoscopy risk, including but not limited to Gold class 3 or 4 COPD, requirement for home oxygen, hypercapneic respiratory failure, poorly controlled hypertension\n3. Known allergy/intolerance to doxycycline, atropine, or any local anesthetic\n4. Inability to provide informed consent\n5. Pregnant or lactating women\n6. Men must agree not to attempt to make a woman pregnant or participate in sperm donation during the study and for 6 weeks after discontinuing the drug\n7. End stage renal disease\n8. Cirrhosis\n9. INR greater than 1.4\n10. Platelets less than 80,000\n11. Any condition including active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements or increase the risk of bronchoscopy\n12. Active or planned participation in any other clinical trial or observational study without prior approval from the PI'}, 'identificationModule': {'nctId': 'NCT01744093', 'briefTitle': 'Doxycycline for COPD in HIV-Infected Patients', 'organization': {'class': 'OTHER', 'fullName': 'Weill Medical College of Cornell University'}, 'officialTitle': 'Doxycycline for COPD in HIV-Infected Patients', 'orgStudyIdInfo': {'id': '1208012780'}, 'secondaryIdInfos': [{'id': 'R34HL117352', 'link': 'https://reporter.nih.gov/quickSearch/R34HL117352', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Doxycycline', 'description': '100 mg twice daily (BID orally) x 24 weeks', 'interventionNames': ['Drug: Doxycycline']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (sugar pill)', 'description': '100 mg twice daily (BID orally) x 24 weeks', 'interventionNames': ['Drug: Placebo (sugar pill)']}], 'interventions': [{'name': 'Doxycycline', 'type': 'DRUG', 'otherNames': ['Vibramycin'], 'description': '100 mg twice daily (BID orally) x 24 weeks', 'armGroupLabels': ['Doxycycline']}, {'name': 'Placebo (sugar pill)', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': '100 mg twice daily (BID orally) x 24 weeks', 'armGroupLabels': ['Placebo (sugar pill)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Genetic Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Robert Kaner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Cornell Medical College-New York Presbyterian Hospital'}, {'name': 'Marshall Glesby, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Cornell Medical College-New York Presbyterian Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}