Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-03-01 @ 3:54 PM
Study NCT ID:
NCT04047420
Status:
COMPLETED
Last Update Posted:
2023-12-22
First Post:
2019-08-05
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Pharmacokinetic Study of Tenofovir Alafenamide (TAF)/Elvitegravir (EVG) Administered Rectally
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'riddler@pitt.edu', 'phone': '4123831741', 'title': 'Sharon Riddler, MD, MPH', 'organization': 'University of Pittsburgh'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Measured from Enrollment through Final Contact at Visit 11 with a median (IQR) of 76 (47, 292) days. COVID restrictions delayed first dosing 9-10 months in 5 participants. Follow-up time from first dosing was a median (IQR) of 34 (22, 39) days.', 'description': 'COVID-19 pandemic related scheduling delays occurred for seven participants resulting in collection of pre-dose adverse events over a 9-10 month period prior to first dosing. Of the 23 participants enrolled, two of these seven participants did not return for first dosing, thus 21 participants received the one insert dose.', 'eventGroups': [{'id': 'EG000', 'title': 'Baseline (Pre-dosing)', 'description': 'All participants who were enrolled in the study, prior to any inserts.', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 3, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'One Insert', 'description': 'All participants who received a single TAF/EVG rectal insert', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 4, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Two Inserts', 'description': 'All participants who received two TAF/EVG rectal inserts', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 4, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Reactogenicity event', 'notes': 'reactogenicity symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthralgia', 'notes': 'right shoulder pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Extrapyramidal disorder', 'notes': 'extrapyramidal symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anal erythema', 'notes': 'rectal erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anal fissure', 'notes': 'Perianal tear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vulvovaginal discomfort', 'notes': 'Minor vaginal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'notes': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Grade 2 and Higher Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One Insert', 'description': 'All participants who received a single TAF/EVG rectal insert'}, {'id': 'OG001', 'title': 'Two Inserts', 'description': 'All participants who received two TAF/EVG rectal inserts'}], 'classes': [{'title': 'Participants experiencing grade 2+ AE', 'categories': [{'title': 'Yes', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Gastritis', 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Reactogenicity event', 'categories': [{'title': 'Yes', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured from Enrollment through Final Contact at Visit 11 with a median (IQR) of 76 (47, 292) days. COVID restrictions delayed first dosing 9-10 months in 5 participants. Follow-up time from first dosing was a median (IQR) of 34 (22, 39) days.', 'description': 'Graded per the Division of AIDS (DAIDS) Table for Grading Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 and/or Addenda 1, 2 and 3 (Female Genital \\[Dated November 2007\\], Male Genital \\[Dated November 2007\\] and Rectal \\[Clarification Dated May 2012\\] Grading Tables for Use in Microbicide Studies).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with dosing of one insert or two inserts.'}, {'type': 'PRIMARY', 'title': 'Elvitegravir (EVG) Concentration in Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One Insert', 'description': 'All participants who received a single TAF/EVG rectal insert'}, {'id': 'OG001', 'title': 'Two Inserts', 'description': 'All participants who received two TAF/EVG rectal inserts'}], 'classes': [{'title': 'Baseline (Enrollment Visit)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Below the Limit of Quantification', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': '1 hour postdosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1010.0', 'groupId': 'OG000', 'lowerLimit': '564.0', 'upperLimit': '2050.0'}, {'value': '1510.0', 'groupId': 'OG001', 'lowerLimit': '812.0', 'upperLimit': '1890.0'}]}]}, {'title': '2 hours postdosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1230', 'groupId': 'OG000', 'lowerLimit': '605.0', 'upperLimit': '3090.0'}, {'value': '2140.0', 'groupId': 'OG001', 'lowerLimit': '1240.0', 'upperLimit': '3420.0'}]}]}, {'title': '4 hours postdosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1080.0', 'groupId': 'OG000', 'lowerLimit': '450.0', 'upperLimit': '1960.0'}, {'value': '1740.0', 'groupId': 'OG001', 'lowerLimit': '933.0', 'upperLimit': '3560.0'}]}]}, {'title': '6 hours postdosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '713.0', 'groupId': 'OG000', 'lowerLimit': '441.0', 'upperLimit': '1730.0'}, {'value': '1290.0', 'groupId': 'OG001', 'lowerLimit': '825.0', 'upperLimit': '2230.0'}]}]}, {'title': '24 hours postdosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '39.0', 'comment': 'Below the Limit of Quantification', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': '201.5'}, {'value': '76.0', 'groupId': 'OG001', 'lowerLimit': '35.0', 'upperLimit': '471.0'}]}]}, {'title': '48 hours postdosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Below the Limit of Quantification', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Below the Limit of Quantification', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': '72 hours postdosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Below the Limit of Quantification', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Below the Limit of Quantification', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Samples collected at baseline (pre dose), 1, 2, 4, 6, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)', 'description': 'Based on laboratory evaluations on samples collected at baseline (pre dose), 1, 2, 4, 6, 24, 48, and 72 hours post dose', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline data were collected once at the enrollment visit prior to receiving both one insert and two inserts.\n\nParticipants had post dose blood samples collected at 1, 2, 4, 6, 24, 48, and 72 hours (One insert (n=21); Two inserts (n=19))).\n\nMissed sample collection (One insert (24-hour missed (n=1)); Two inserts (48-hour missed (n=1) and 72-hour missed (n=1))).\n\nUnable to draw sample (One insert (72-hours (n=1))).'}, {'type': 'PRIMARY', 'title': 'Elvitegravir (EVG) Concentration in Rectal Fluid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One Insert', 'description': 'All participants who received a single TAF/EVG rectal insert'}, {'id': 'OG001', 'title': 'Two Inserts', 'description': 'All participants who received two TAF/EVG rectal inserts'}], 'classes': [{'title': '2 hours postdosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '67542.0', 'groupId': 'OG000', 'lowerLimit': '31652.0', 'upperLimit': '338721.0'}, {'value': '176672.0', 'groupId': 'OG001', 'lowerLimit': '50962.0', 'upperLimit': '731606.0'}]}]}, {'title': '4 hours postdosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '125676.0', 'groupId': 'OG000', 'lowerLimit': '72779.0', 'upperLimit': '319693.0'}, {'value': '93888.5', 'groupId': 'OG001', 'lowerLimit': '49922.0', 'upperLimit': '236267.0'}]}]}, {'title': '6 hours postdosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4095.5', 'groupId': 'OG000', 'lowerLimit': '338.0', 'upperLimit': '8708.0'}, {'value': '7791.0', 'groupId': 'OG001', 'lowerLimit': '619.0', 'upperLimit': '13131.0'}]}]}, {'title': '24 hours postdosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2233.5', 'groupId': 'OG000', 'lowerLimit': '574.0', 'upperLimit': '3517.0'}, {'value': '2596.5', 'groupId': 'OG001', 'lowerLimit': '89.1', 'upperLimit': '18664.0'}]}]}, {'title': '48 hours postdosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.9', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '278.0'}, {'value': '36.4', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '807.5'}]}]}, {'title': '72 hours postdosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.9', 'comment': 'Below the Limit of Quantification', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': '16.5'}, {'value': '29.1', 'groupId': 'OG001', 'lowerLimit': '2.3', 'upperLimit': '58.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Samples collected at 2, 4, 6, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)', 'description': 'Based on laboratory evaluations on samples collected at 2, 4, 6, 24, 48, and 72 hours post dose', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants are randomly assigned 1:1 to post dose rectal fluid sampling at either 2, 6, and 48 hours (One insert (n=10); Two inserts (n=9)) or 4, 24, and 72 hours (One insert (n=11); Two inserts (n=10)).\n\nMissed sample collection (One insert (24-hour missed (n=1) but replaced by 48-hour sample); Two inserts (48-hour missed (n=1))).'}, {'type': 'PRIMARY', 'title': 'Elvitegravir (EVG) Concentration in Rectal Mucosal Tissue Homogenates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One Insert', 'description': 'All participants who received a single TAF/EVG rectal insert'}, {'id': 'OG001', 'title': 'Two Inserts', 'description': 'All participants who received two TAF/EVG rectal inserts'}], 'classes': [{'title': '2 hours postdosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.4', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '10.2'}, {'value': '9.0', 'groupId': 'OG001', 'lowerLimit': '5.3', 'upperLimit': '35.3'}]}]}, {'title': '24 hours postdosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Below the Limit of Quantification', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.1', 'comment': 'Below the Limit of Quantification', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': '0.7'}]}]}, {'title': '48 hours postdosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Below the Limit of Quantification', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Below the Limit of Quantification', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': '72 hours postdosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Below the Limit of Quantification', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Below the Limit of Quantification', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Samples collected at 2, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)', 'description': 'Based on laboratory evaluations on samples collected at 2, 24, 48, and 72 hours post dose', 'unitOfMeasure': 'ng/mg', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants are randomly assigned 1:1 to post dose rectal tissue sampling at either 2 and 48 hours (One insert (n=10)); Two inserts (n=9)) or 24 and 72 hours (One insert (n=11); Two inserts (n=10)).\n\nMissed sample collection (One insert (24-hour missed (n=1)); Two inserts (48-hour missed (n=1) and 72-hour missed (n=1))).'}, {'type': 'PRIMARY', 'title': 'Tenofovir Alafenamide (TAF) Concentration in Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One Insert', 'description': 'All participants who received a single TAF/EVG rectal insert'}, {'id': 'OG001', 'title': 'Two Inserts', 'description': 'All participants who received two TAF/EVG rectal inserts'}], 'classes': [{'title': 'Baseline (Enrollment visit)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Below the Limit of Quantification', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': '1 hour postdosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29500.0', 'groupId': 'OG000', 'lowerLimit': '16700.0', 'upperLimit': '37900.0'}, {'value': '40400.0', 'groupId': 'OG001', 'lowerLimit': '22600.0', 'upperLimit': '65900.0'}]}]}, {'title': '2 hours postdosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14000.0', 'groupId': 'OG000', 'lowerLimit': '5850.0', 'upperLimit': '32100.0'}, {'value': '26200.0', 'groupId': 'OG001', 'lowerLimit': '8970.0', 'upperLimit': '54300.0'}]}]}, {'title': '4 hours postdosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '747.0', 'groupId': 'OG000', 'lowerLimit': '169.0', 'upperLimit': '1660.0'}, {'value': '1350.0', 'groupId': 'OG001', 'lowerLimit': '525.0', 'upperLimit': '6650.0'}]}]}, {'title': '6 hours postdosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '56.0', 'comment': 'Below the Limit of Quantification', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': '222.0'}, {'value': '95.0', 'groupId': 'OG001', 'lowerLimit': '27.0', 'upperLimit': '427.0'}]}]}, {'title': '24 hours postdosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Below the Limit of Quantification', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Below the Limit of Quantification', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': '48 hours postdosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Below the Limit of Quantification', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Below the Limit of Quantification', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': '72 hours postdosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Below the Limit of Quantification', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Below the Limit of Quantification', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Samples collected at baseline (pre dose), 1, 2, 4, 6, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)', 'description': 'Based on laboratory evaluations on samples collected at baseline (pre dose), 1, 2, 4, 6, 24, 48, and 72 hours post dose', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline data were collected once at the enrollment visit prior to receiving both one insert and two inserts.\n\nParticipants had post dose blood samples collected at 1, 2, 4, 6, 24, 48, and 72 hours (One insert (n=21); Two inserts (n=19))).\n\nMissed sample collection (One insert (24-hour missed (n=1)); Two inserts (48-hour missed (n=1) and 72-hour missed (n=1))).\n\nUnable to draw sample (One insert (72-hours (n=1))).'}, {'type': 'PRIMARY', 'title': 'Tenofovir Alafenamide (TAF) Concentration in Rectal Fluid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One Insert', 'description': 'All participants who received a single TAF/EVG rectal insert'}, {'id': 'OG001', 'title': 'Two Inserts', 'description': 'All participants who received two TAF/EVG rectal inserts'}], 'classes': [{'title': '2 hours postdosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1394.0', 'groupId': 'OG000', 'lowerLimit': '358.0', 'upperLimit': '6085.0'}, {'value': '531.0', 'groupId': 'OG001', 'lowerLimit': '196.0', 'upperLimit': '16080.0'}]}]}, {'title': '4 hours postdosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1279.0', 'groupId': 'OG000', 'lowerLimit': '53.7', 'upperLimit': '6056.0'}, {'value': '954.0', 'groupId': 'OG001', 'lowerLimit': '308.0', 'upperLimit': '6008.0'}]}]}, {'title': '6 hours postdosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.8', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '30.1'}, {'value': '12.4', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '58.4'}]}]}, {'title': '24 hours postdosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Below the Limit of Quantification', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.6', 'comment': 'Below the Limit of Quantification', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': '3.9'}]}]}, {'title': '48 hours postdosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Below the Limit of Quantification', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Below the Limit of Quantification', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': '72 hours postdosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Below the Limit of Quantification', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Below the Limit of Quantification', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Samples collected at 2, 4, 6, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)', 'description': 'Based on laboratory evaluations on samples 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single TAF/EVG rectal insert'}, {'id': 'OG001', 'title': 'Two Inserts', 'description': 'All participants who received two TAF/EVG rectal inserts'}], 'classes': [{'title': '2 hours postdosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Below the Limit of Quantification', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': '0.1'}, {'value': 'NA', 'comment': 'Below the Limit of Quantification', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': '0.1'}]}]}, {'title': '24 hours postdosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Below the Limit of Quantification', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Below the Limit of Quantification', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': '48 hours postdosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Below the Limit of Quantification', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Below the Limit of Quantification', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': '72 hours postdosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Below the Limit of Quantification', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Below the Limit of Quantification', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Samples collected at 2, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)', 'description': 'Based on laboratory evaluations on samples collected at 2, 24, 48, and 72 hours post dose', 'unitOfMeasure': 'ng/mg', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants are randomly assigned 1:1 to post dose rectal tissue sampling at either 2 and 48 hours (One insert (n=10)); Two inserts (n=9)) or 24 and 72 hours (One insert (n=11); Two inserts (n=10)).\n\nMissed sample collection (One insert (24-hour missed (n=1)); Two inserts (48-hour missed (n=1) and 72-hour missed (n=1))).'}, {'type': 'PRIMARY', 'title': 'Tenofovir (TFV) Concentration in Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One Insert', 'description': 'All participants who received a single TAF/EVG rectal insert'}, {'id': 'OG001', 'title': 'Two Inserts', 'description': 'All participants who received two TAF/EVG rectal inserts'}], 'classes': [{'title': 'Baseline (Enrollment visit)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Below the Limit of Quantification', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': '1 hour postdosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1290.0', 'groupId': 'OG000', 'lowerLimit': '796.0', 'upperLimit': '1880.0'}, {'value': '2140.0', 'groupId': 'OG001', 'lowerLimit': '1520.0', 'upperLimit': '3070.0'}]}]}, {'title': '2 hours postdosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2080.0', 'groupId': 'OG000', 'lowerLimit': '1690.0', 'upperLimit': '3430.0'}, {'value': '3700.0', 'groupId': 'OG001', 'lowerLimit': '2490.0', 'upperLimit': '5170.0'}]}]}, {'title': '4 hours postdosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2380.0', 'groupId': 'OG000', 'lowerLimit': '1510.0', 'upperLimit': '3580.0'}, {'value': '4080.0', 'groupId': 'OG001', 'lowerLimit': '2360.0', 'upperLimit': '5520.0'}]}]}, {'title': '6 hours postdosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1780.0', 'groupId': 'OG000', 'lowerLimit': '1050.0', 'upperLimit': '3010.0'}, {'value': '3420.0', 'groupId': 'OG001', 'lowerLimit': '1910.0', 'upperLimit': '4640.0'}]}]}, {'title': '24 hours postdosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1105.0', 'groupId': 'OG000', 'lowerLimit': '558.5', 'upperLimit': '1995.0'}, {'value': '1910.0', 'groupId': 'OG001', 'lowerLimit': '1100.0', 'upperLimit': '3210.0'}]}]}, {'title': '48 hours postdosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '570.0', 'groupId': 'OG000', 'lowerLimit': '311.0', 'upperLimit': '1020.0'}, {'value': '1085.0', 'groupId': 'OG001', 'lowerLimit': '852.0', 'upperLimit': '1480.0'}]}]}, {'title': '72 hours postdosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '340.5', 'groupId': 'OG000', 'lowerLimit': '133.0', 'upperLimit': '696.0'}, {'value': '687.0', 'groupId': 'OG001', 'lowerLimit': '438.0', 'upperLimit': '841.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Samples collected at baseline (pre dose), 1, 2, 4, 6, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)', 'description': 'Based on laboratory evaluations on samples collected at baseline (pre dose), 1, 2, 4, 6, 24, 48, and 72 hours post dose', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline data were collected once at the enrollment visit prior to receiving both one insert and two inserts.\n\nParticipants had post dose blood samples collected at 1, 2, 4, 6, 24, 48, and 72 hours (One insert (n=21); Two inserts (n=19))).\n\nMissed sample collection (One insert (24-hour missed (n=1)); Two inserts (48-hour missed (n=1) and 72-hour missed (n=1))).\n\nUnable to draw sample (One insert (72-hours (n=1))).'}, {'type': 'PRIMARY', 'title': 'Tenofovir (TFV) Concentration in Rectal Fluid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One Insert', 'description': 'All participants who received a single TAF/EVG rectal insert'}, {'id': 'OG001', 'title': 'Two Inserts', 'description': 'All participants who received two TAF/EVG rectal inserts'}], 'classes': [{'title': '2 hours postdosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18086.0', 'groupId': 'OG000', 'lowerLimit': '15509.0', 'upperLimit': '34292.0'}, {'value': '43188.0', 'groupId': 'OG001', 'lowerLimit': '26667.0', 'upperLimit': '78240.0'}]}]}, {'title': '4 hours post dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '85434.0', 'groupId': 'OG000', 'lowerLimit': '37836.0', 'upperLimit': '126430.0'}, {'value': '100834.5', 'groupId': 'OG001', 'lowerLimit': '58003.0', 'upperLimit': '141675.0'}]}]}, {'title': '6 hours postdosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9794.0', 'groupId': 'OG000', 'lowerLimit': '2076.5', 'upperLimit': '18268.0'}, {'value': '10214.5', 'groupId': 'OG001', 'lowerLimit': '5255.0', 'upperLimit': '26800.5'}]}]}, {'title': '24 hours postdosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2909.0', 'groupId': 'OG000', 'lowerLimit': '1744.0', 'upperLimit': '8465.0'}, {'value': '8276.5', 'groupId': 'OG001', 'lowerLimit': '5261.0', 'upperLimit': '23540.0'}]}]}, {'title': '48 hours postdosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '924.0', 'groupId': 'OG000', 'lowerLimit': '337.0', 'upperLimit': '2010.0'}, {'value': '1057.0', 'groupId': 'OG001', 'lowerLimit': '687.0', 'upperLimit': '2289.0'}]}]}, {'title': '72 hours postdosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '380.0', 'groupId': 'OG000', 'lowerLimit': '41.8', 'upperLimit': '881.0'}, {'value': '545.5', 'groupId': 'OG001', 'lowerLimit': '78.2', 'upperLimit': '1011.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Samples collected at 2, 4, 6, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)', 'description': 'Based on laboratory evaluations on samples collected at 2, 4, 6, 24, 48, and 72 hours post dose', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants are randomly assigned 1:1 to post dose rectal fluid sampling at either 2, 6, and 48 hours (One insert (n=10); Two inserts (n=9)) or 4, 24, and 72 hours (One insert (n=11); Two inserts (n=10)).\n\nMissed sample collection (One insert (24-hour missed (n=1) but replaced by 48-hour sample); Two inserts (48-hour missed (n=1))).\n\nRejected samples, no results (One insert (2-hours (n=1), 4-hours (n=2), and 6-hours (n=2)); Two inserts (6-hours (n=1) and 48-hours (n=1))).'}, {'type': 'PRIMARY', 'title': 'Tenofovir (TFV) Concentration in Rectal Mucosal Tissue Homogenates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One Insert', 'description': 'All participants who received a single TAF/EVG rectal insert'}, {'id': 'OG001', 'title': 'Two Inserts', 'description': 'All participants who received two TAF/EVG rectal inserts'}], 'classes': [{'title': '2 hours postdosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.4', 'groupId': 'OG000', 'lowerLimit': '3.2', 'upperLimit': '35.6'}, {'value': '28.4', 'groupId': 'OG001', 'lowerLimit': '16.7', 'upperLimit': '40.6'}]}]}, {'title': '24 hours postdosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '9.8'}, {'value': '10.2', 'groupId': 'OG001', 'lowerLimit': '2.5', 'upperLimit': '21.9'}]}]}, {'title': '48 hours postdosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.3', 'comment': 'Below the Limit of Quantification', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': '5.1'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '2.3', 'upperLimit': '5.5'}]}]}, {'title': '72 hours postdosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Below the Limit of Quantification', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': '2.1'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '5.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Samples collected at 2, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)', 'description': 'Based on laboratory evaluations on samples collected at 2, 24, 48, and 72 hours post dose', 'unitOfMeasure': 'ng/mg', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants are randomly assigned 1:1 to post dose rectal tissue sampling at either 2 and 48 hours (One insert (n=10)); Two inserts (n=9)) or 24 and 72 hours (One insert (n=11); Two inserts (n=10)).\n\nMissed sample collection (One insert (24-hour missed (n=1)); Two inserts (48-hour missed (n=1) and 72-hour missed (n=1))).'}, {'type': 'PRIMARY', 'title': 'Tenofovir Diphosphate (TFV-DP) Concentration in Rectal Mucosal Tissue Cell Isolates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One Insert', 'description': 'All participants who received a single TAF/EVG rectal insert'}, {'id': 'OG001', 'title': 'Two Inserts', 'description': 'All participants who received two TAF/EVG rectal inserts'}], 'classes': [{'title': '2 hours postdosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8219.0', 'groupId': 'OG000', 'lowerLimit': '3443.0', 'upperLimit': '12723.0'}, {'value': '6230.0', 'groupId': 'OG001', 'lowerLimit': '5704.0', 'upperLimit': '12783.0'}]}]}, {'title': '24 hours postdosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2315.5', 'groupId': 'OG000', 'lowerLimit': '335.0', 'upperLimit': '8055.0'}, {'value': '6727.0', 'groupId': 'OG001', 'lowerLimit': '2189.0', 'upperLimit': '12295.0'}]}]}, {'title': '48 hours postdosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2459.0', 'groupId': 'OG000', 'lowerLimit': '89.0', 'upperLimit': '4559.0'}, {'value': '2822.0', 'groupId': 'OG001', 'lowerLimit': '815.0', 'upperLimit': '3599.0'}]}]}, {'title': '72 hours postdosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '149.0', 'groupId': 'OG000', 'lowerLimit': '43.6', 'upperLimit': '1075.0'}, {'value': '2022.0', 'groupId': 'OG001', 'lowerLimit': '347.0', 'upperLimit': '3122.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Samples collected at 2, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)', 'description': 'Based on laboratory evaluations on samples collected at 2, 24, 48, and 72 hours post dose', 'unitOfMeasure': 'fmol/10^6 Cells', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants are randomly assigned 1:1 to post dose rectal tissue sampling at either 2 and 48 hours (One insert (n=10)); Two inserts (n=9)) or 24 and 72 hours (One insert (n=11); Two inserts (n=10)).\n\nMissed sample collection (One insert (24-hour missed (n=1)); Two inserts (48-hour missed (n=1) and 72-hour missed (n=1))).\n\nRejected samples, no results (One insert (2-hours (n=2) and 48-hours (n=2)); Two inserts (48-hours (n=1) and 72-hours (n=1))).'}, {'type': 'SECONDARY', 'title': 'Participant Self-report Rectal Insert Acceptability - Ease of Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One Insert', 'description': 'All participants who received a single TAF/EVG rectal insert'}, {'id': 'OG001', 'title': 'Two Inserts', 'description': 'All participants who received two TAF/EVG rectal inserts'}], 'classes': [{'categories': [{'title': 'Very difficult', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Difficult', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Easy', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}, {'title': 'Very easy', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': 'Decline to answer', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours after each dose (Visits 4 and 8) (up to 9 weeks after first dose)', 'description': 'Response for "Overall, how easy or difficult was it to use the study product when inserted by clinic staff?', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who completed the follow-up computer-administered self-interview (CASI) questionnaire at 24 hours post-dosing.'}, {'type': 'SECONDARY', 'title': 'Participant Self-report Rectal Insert Acceptability - Feeling When Inserted', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One Insert', 'description': 'All participants who received a single TAF/EVG rectal insert'}, {'id': 'OG001', 'title': 'Two Inserts', 'description': 'All participants who received two TAF/EVG rectal inserts'}], 'classes': [{'categories': [{'title': 'Very comfortable', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}, {'title': 'Comfortable', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'Uncomfortable', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Very uncomfortable', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Decline to answer', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours after each dose (Visits 4 and 8) (up to 9 weeks after first dose)', 'description': 'Response for "How did it feel to have the insert inside you?"', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who completed the follow-up computer-administered self-interview (CASI) questionnaire at 24 hours post-dosing.'}, {'type': 'SECONDARY', 'title': 'Participant Self-report Rectal Insert Acceptability - Problems With Rectal Insert', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One Insert', 'description': 'All participants who received a single TAF/EVG rectal insert'}, {'id': 'OG001', 'title': 'Two Inserts', 'description': 'All participants who received two TAF/EVG rectal inserts'}], 'classes': [{'title': 'Did you have any problems using the study insert after it was inserted?', 'categories': [{'title': 'No', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}, {'title': 'Yes', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Decline to answer', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Did you experience any leakage after you used the insert?', 'categories': [{'title': 'No', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}, {'title': 'Yes', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Decline to answer', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Since your last study visit, have you experienced any soiling of your underwear or linens?', 'categories': [{'title': 'No', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}, {'title': 'Yes', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Decline to answer', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Since your last study visit, have you experienced any diarrhea?', 'categories': [{'title': 'No', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}, {'title': 'Yes', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Decline to answer', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Since your last visit, have you experienced any other stomach or abdominal problems?', 'categories': [{'title': 'No', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': 'Yes', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'Decline to answer', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours after each dose (Visits 4 and 8) (up to 9 weeks after first dose)', 'description': 'Responses for questions related to problems with Rectal Insert', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who completed the follow-up computer-administered self-interview (CASI) questionnaire at 24 hours post-dosing.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tenofovir Alafenamide (TAF)/Elvitegravir (EVG) Insert', 'description': 'On the first dosing visit (Visit 3), participants will receive a single TAF/EVG Insert for rectal administration. On the second dosing visit (Visit 7), after a washout period of at least 7 days, participants will receive two TAF/EVG Inserts for rectal administration. Each participant will be on study for approximately 6-13 weeks.\n\nTAF/EVG Insert: TAF/EVG Insert (20/16 mg) administered rectally by study staff'}], 'periods': [{'title': 'Enrollment (Pre-dose) Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Refused Participation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}, {'title': 'One TAF/EVG Insert Dose', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Washout Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Refused Participation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}, {'title': 'Two TAF/EVG Inserts Dose', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'A total of 23 participants were eligible and enrolled. Two participants terminated early due to "Refused participation", so 21 participants received the one insert dose. After the one insert dose, two additional participants terminated early due to "Refused participation", so 19 participants received the two insert dose.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Tenofovir Alafenamide (TAF)/Elvitegravir (EVG) Insert', 'description': 'On the first dosing visit (Visit 3), participants will receive a single TAF/EVG Insert for rectal administration. On the second dosing visit (Visit 7), after a washout period of at least 7 days, participants will receive two TAF/EVG Inserts for rectal administration. Each participant will be on study for approximately 6-13 weeks.\n\nTAF/EVG Insert: TAF/EVG Insert (20/16 mg) administered rectally by study staff'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34.0', 'groupId': 'BG000', 'lowerLimit': '24', 'upperLimit': '43'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Age, Customized', 'classes': [{'title': '24 years or Under', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': '25-29 years', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': '30-34 years', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': '35-39 years', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': '40-44 years', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': '45-49 years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': '50+ years', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Gender', 'categories': [{'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Transgender Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Transgender Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Gender Nonconforming/Gender Variant', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Self-identify', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Prefer Not to Answer', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Multiple Genders', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'at birth', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Other', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Mixed', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'title': 'Pittsburgh', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Birmingham', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sexual Orientation', 'classes': [{'categories': [{'title': 'Gay/Lesbian/Homosexual', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Bisexual', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Queer', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Two Spirit', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Straight/Heterosexual', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Additional Category', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not sure', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Prefer not to Answer', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Participant Height (cm)', 'classes': [{'categories': [{'measurements': [{'value': '175.0', 'groupId': 'BG000', 'lowerLimit': '166', 'upperLimit': '182'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'cm', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Participant Weight (kg)', 'classes': [{'categories': [{'measurements': [{'value': '93.0', 'groupId': 'BG000', 'lowerLimit': '75', 'upperLimit': '116'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Participant BMI (kg/m^2)', 'classes': [{'categories': [{'measurements': [{'value': '30.8', 'groupId': 'BG000', 'lowerLimit': '26', 'upperLimit': '37'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-09-30', 'size': 1323463, 'label': 'Study Protocol and Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'Prot_ICF_000.pdf', 'typeAbbrev': 'Prot_ICF', 'uploadDate': '2023-09-11T20:27', 'hasProtocol': True}, {'date': '2021-10-08', 'size': 446391, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-09-11T20:25', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2021-04-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-04', 'studyFirstSubmitDate': '2019-08-05', 'resultsFirstSubmitDate': '2023-09-14', 'studyFirstSubmitQcDate': '2019-08-05', 'lastUpdatePostDateStruct': {'date': '2023-12-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-12-04', 'studyFirstPostDateStruct': {'date': '2019-08-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-12-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Grade 2 and Higher Adverse Events (AEs)', 'timeFrame': 'Measured from Enrollment through Final Contact at Visit 11 with a median (IQR) of 76 (47, 292) days. COVID restrictions delayed first dosing 9-10 months in 5 participants. Follow-up time from first dosing was a median (IQR) of 34 (22, 39) days.', 'description': 'Graded per the Division of AIDS (DAIDS) Table for Grading Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 and/or Addenda 1, 2 and 3 (Female Genital \\[Dated November 2007\\], Male Genital \\[Dated November 2007\\] and Rectal \\[Clarification Dated May 2012\\] Grading Tables for Use in Microbicide Studies).'}, {'measure': 'Elvitegravir (EVG) Concentration in Blood', 'timeFrame': 'Samples collected at baseline (pre dose), 1, 2, 4, 6, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)', 'description': 'Based on laboratory evaluations on samples collected at baseline (pre dose), 1, 2, 4, 6, 24, 48, and 72 hours post dose'}, {'measure': 'Elvitegravir (EVG) Concentration in Rectal Fluid', 'timeFrame': 'Samples collected at 2, 4, 6, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)', 'description': 'Based on laboratory evaluations on samples collected at 2, 4, 6, 24, 48, and 72 hours post dose'}, {'measure': 'Elvitegravir (EVG) Concentration in Rectal Mucosal Tissue Homogenates', 'timeFrame': 'Samples collected at 2, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)', 'description': 'Based on laboratory evaluations on samples collected at 2, 24, 48, and 72 hours post dose'}, {'measure': 'Tenofovir Alafenamide (TAF) Concentration in Blood', 'timeFrame': 'Samples collected at baseline (pre dose), 1, 2, 4, 6, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)', 'description': 'Based on laboratory evaluations on samples collected at baseline (pre dose), 1, 2, 4, 6, 24, 48, and 72 hours post dose'}, {'measure': 'Tenofovir Alafenamide (TAF) Concentration in Rectal Fluid', 'timeFrame': 'Samples collected at 2, 4, 6, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)', 'description': 'Based on laboratory evaluations on samples collected at 2, 4, 6, 24, 48, and 72 hours post dose'}, {'measure': 'Tenofovir Alafenamide (TAF) Concentration in Rectal Mucosal Tissue Homogenates', 'timeFrame': 'Samples collected at 2, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)', 'description': 'Based on laboratory evaluations on samples collected at 2, 24, 48, and 72 hours post dose'}, {'measure': 'Tenofovir (TFV) Concentration in Blood', 'timeFrame': 'Samples collected at baseline (pre dose), 1, 2, 4, 6, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)', 'description': 'Based on laboratory evaluations on samples collected at baseline (pre dose), 1, 2, 4, 6, 24, 48, and 72 hours post dose'}, {'measure': 'Tenofovir (TFV) Concentration in Rectal Fluid', 'timeFrame': 'Samples collected at 2, 4, 6, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)', 'description': 'Based on laboratory evaluations on samples collected at 2, 4, 6, 24, 48, and 72 hours post dose'}, {'measure': 'Tenofovir (TFV) Concentration in Rectal Mucosal Tissue Homogenates', 'timeFrame': 'Samples collected at 2, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)', 'description': 'Based on laboratory evaluations on samples collected at 2, 24, 48, and 72 hours post dose'}, {'measure': 'Tenofovir Diphosphate (TFV-DP) Concentration in Rectal Mucosal Tissue Cell Isolates', 'timeFrame': 'Samples collected at 2, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)', 'description': 'Based on laboratory evaluations on samples collected at 2, 24, 48, and 72 hours post dose'}], 'secondaryOutcomes': [{'measure': 'Participant Self-report Rectal Insert Acceptability - Ease of Use', 'timeFrame': '24 hours after each dose (Visits 4 and 8) (up to 9 weeks after first dose)', 'description': 'Response for "Overall, how easy or difficult was it to use the study product when inserted by clinic staff?'}, {'measure': 'Participant Self-report Rectal Insert Acceptability - Feeling When Inserted', 'timeFrame': '24 hours after each dose (Visits 4 and 8) (up to 9 weeks after first dose)', 'description': 'Response for "How did it feel to have the insert inside you?"'}, {'measure': 'Participant Self-report Rectal Insert Acceptability - Problems With Rectal Insert', 'timeFrame': '24 hours after each dose (Visits 4 and 8) (up to 9 weeks after first dose)', 'description': 'Responses for questions related to problems with Rectal Insert'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '38655842', 'type': 'DERIVED', 'citation': 'Riddler SA, Kelly CW, Hoesley CJ, Ho KS, Piper JM, Edick S, Heard F, Doncel GF, Johnson S, Anderson PL, Brand RM, Kunjara Na Ayudhya RP, Bauermeister JA, Hillier SL, Hendrix CW. A Phase 1 Clinical Trial to Assess the Safety and Pharmacokinetics of a Tenofovir Alafenamide/Elvitegravir Insert Administered Rectally for HIV Prevention. J Infect Dis. 2024 Sep 23;230(3):696-705. doi: 10.1093/infdis/jiae211.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and pharmacokinetics of rectal administration of a tenofovir alafenamide (TAF)/elvitegravir (EVG) insert at two dose levels in HIV-uninfected individuals.', 'detailedDescription': 'This study will evaluate the safety and pharmacokinetics of rectal administration of a tenofovir alafenamide (TAF)/elvitegravir (EVG) insert at two dose levels in HIV-uninfected individuals.\n\nAll participants will receive a single TAF/EVG Insert at Study Visit 3. After a washout period of at least 7 days, participants will receive two TAF/EVG Inserts at Study Visit 7. The inserts will be administered rectally by study staff. After each dosing visit, samples will be collected over a 3-day period.\n\nParticipants will attend 10 study visits and will be followed for approximately 6 to 13 weeks. Study visits may include physical and rectal examinations; collection of blood, urine, rectal and vaginal fluid; and interviews. The total duration of the study will be approximately 11 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals who are 18 years of age or older at Screening, verified per site standard operating procedure (SOP)\n* Able and willing to provide written informed consent to be screened for and enrolled in MTN-039\n* HIV-1/2 uninfected at Screening and Enrollment, per applicable algorithm in the study protocol and willing to receive HIV test results\n* Able and willing to provide adequate locator information, as defined in site SOP\n* Able to communicate in spoken and written English\n* Available for all visits and able and willing to comply with all study procedural requirements\n* In general good health at Screening and Enrollment, as determined by the site Investigator of Record (IoR) or designee\n* At Screening, history of consensual receptive anal intercourse (RAI) at least once in lifetime per participant report\n* Willing not to take part in other research studies involving drugs, medical devices, genital or rectal products, or vaccines for the duration of study participation (including the time between Screening and Enrollment)\n* Willing to comply with abstinence and other protocol requirements as outlined in the study protocol\n* For participants of childbearing potential: a negative pregnancy test at Screening and Enrollment\n* For participants of childbearing potential: Per participant report at Enrollment, using an effective method of contraception for at least 30 days (inclusive) prior to Enrollment and intending to use an effective method for the duration of study participation. Effective methods include:\n\n * Hormonal methods\n * Intrauterine device (IUD) inserted at least 30 days prior to Enrollment (but not past the maximum length of recommended usage according to package instructions)\n * Sterilization (of participant or partner, as defined in site SOPs)\n * Sexually abstinent as defined by abstaining from penile-vaginal intercourse for 90 days prior to Enrollment and intending to remain abstinent for the duration of study participation; this includes having sex exclusively with individuals assigned female sex at birth\n\nExclusion Criteria:\n\n* At Screening:\n\n * Hemoglobin Grade 1 or higher\\*\n * Platelet count Grade 1 or higher\\*\n * Aspartate aminotransferase (AST) or alanine transaminase (ALT) Grade 1 or higher\\*\n * Serum creatinine greater than 1.3 times the site laboratory upper limit of normal (ULN)\n * International normalized ratio (INR) greater than 1.5 times the site laboratory ULN\n * History of inflammatory bowel disease by participant report\n * Positive hepatitis B surface antigen (HBsAg) test result\n * \\*As per the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Corrected Version 2.1, July 2017.\n * Note: Otherwise eligible participants with an exclusionary test result (other than HIV) can be re-tested during the screening process. If a participant is re-tested and a non-exclusionary result is documented within 45 days of providing informed consent for screening, the participant may be enrolled.\n* Anticipated use of and/or unwillingness to abstain from the following medications during study participation:\n\n * Anticoagulant medications\n * Non-study rectally-administered medications and any products containing nonoxynol-9 (N-9)\n* Known adverse reaction to any of the components of the study product\n* Use of approved or other investigational pre-exposure prophylaxis (PrEP) for HIV prevention within 3 months prior to Enrollment, and/or anticipated use and/or unwillingness to abstain from PrEP during trial participation\n* Use of post-exposure prophylaxis (PEP) for potential HIV exposure within 6 months prior to Enrollment\n* Condomless RAI and/or penile-vaginal intercourse with a partner who is known to be HIV-positive or whose status is unknown in the 6 months prior to Enrollment\n* History of transactional sex in the 12 months prior to Enrollment\n* Non-therapeutic injection drug use or use of non-therapeutic, non-injection stimulant drugs in the 12 months prior to Enrollment\n* Participation in research studies involving drugs, medical devices, genital or rectal products, or vaccines within 30 days of the Enrollment Visit\n* Per participant report, medical records, clinical diagnosis and/or diagnostic testing at either Screening or Enrollment:\n\n * Diagnosis or treatment of an anogenital sexually transmitted infection (STI) in the 3 months prior to enrollment (including window between Screening and Enrollment).\n * Symptoms, clinical or laboratory diagnosis of active pharyngeal, anorectal, or reproductive tract infection (RTI) requiring treatment per current Centers for Disease Control and Prevention (CDC) guidelines (http://www.cdc.gov/std/treatment).\n * Current symptomatic urinary tract infection (UTI).\n\n * Infections requiring treatment include Neisseria gonorrhea (GC), Chlamydia trachomatis (CT) infection, syphilis, active herpes simplex virus (HSV) lesions, or symptomatic genital warts, chancroid, pelvic inflammatory disease (PID), bacterial vaginosis (BV), symptomatic vaginal candidiasis, and trichomoniasis.\n * Note: Otherwise eligible participants with an exclusionary UTI, BV and/or candida finding may be re-tested during the screening process.\n* For participants of childbearing potential: Pregnant or breastfeeding at either Screening or Enrollment or planning to become pregnant during study participation\n\n * Note: A documented negative pregnancy test performed by study staff is required for inclusion; however, a self-reported pregnancy is adequate for exclusion from screening/enrollment into the study.\n* For participants of childbearing potential: Last pregnancy outcome 90 days or less prior to Screening\n* Has any other condition that, in the opinion of the IoR/designee, would preclude informed consent, make study participation unsafe, complicate the interpretation of study outcome data, or otherwise interfere with achieving the study objectives including any significant uncontrolled active or chronic medical condition.'}, 'identificationModule': {'nctId': 'NCT04047420', 'briefTitle': 'Safety and Pharmacokinetic Study of Tenofovir Alafenamide (TAF)/Elvitegravir (EVG) Administered Rectally', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'A Phase 1 Open Label Safety and Pharmacokinetic Study of Rectal Administration of a Tenofovir Alafenamide/Elvitegravir Insert at Two Dose Levels', 'orgStudyIdInfo': {'id': 'MTN-039'}, 'secondaryIdInfos': [{'id': '38470', 'type': 'REGISTRY', 'domain': 'DAIDS-ES Registry Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tenofovir Alafenamide (TAF)/Elvitegravir (EVG) Insert', 'description': 'On the first dosing visit (Visit 3), participants will receive a single TAF/EVG Insert for rectal administration. On the second dosing visit (Visit 7), after a washout period of at least 7 days, participants will receive two TAF/EVG Inserts for rectal administration. Each participant will be on study for approximately 6-13 weeks.', 'interventionNames': ['Drug: TAF/EVG Insert']}], 'interventions': [{'name': 'TAF/EVG Insert', 'type': 'DRUG', 'description': 'TAF/EVG Insert (20/16 mg) administered rectally by study staff', 'armGroupLabels': ['Tenofovir Alafenamide (TAF)/Elvitegravir (EVG) Insert']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama CRS', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh CRS', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Sharon A. Riddler, MD, MPH', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, 'collaborators': [{'name': 'CONRAD', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}