Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2025-12-26 @ 3:52 AM
Study NCT ID:
NCT04319718
Status:
COMPLETED
Last Update Posted:
2023-03-03
First Post:
2020-03-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Pharmacokinetics of Two Vaginal Film Formulations Containing the Integrase Inhibitor MK-2048
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'meynla@mwri.magee.edu', 'phone': '412-641-4233', 'title': 'Dr. Leslie Meyn, Research Assistant Professor', 'organization': 'University of Pittsburgh'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'After 25 participants were enrolled, 2 of 12 participants randomized to the low Eudragit® film arm had product discontinuations due to vaginal irritation and lack of product tolerability. The Protocol Safety Review Team voted to discontinue the low Eudragit® film arm resulting in only 12 participants of the 25 planned enrolled into that study arm. This limited the power of the study to detect significant differences in the outcomes between the two film arms.'}}, 'adverseEventsModule': {'timeFrame': '1 month', 'eventGroups': [{'id': 'EG000', 'title': 'High Eudragit MK-2048 Vaginal Film', 'description': 'Single use of 2" x 2" vaginal film containing 30 mg of MK-2048 and 68.1 mg of ammonio methacrylate copolymer type B (Eudragit®).\n\nMK-2048 High Eudragit Vaginal Film: 2" x 2" vaginal film containing 30 mg of MK-2048 and 68.1 mg of ammonio methacrylate copolymer type B (Eudragit®)', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 17, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Low Eudragit MK-2048 Vaginal Film', 'description': 'Single use of 2" x 2" vaginal film containing 30 mg of MK-2048 and 41.5 mg of ammonio methacrylate copolymer type B (Eudragit®).\n\nMK-2048 Low Eudragit Vaginal Film: 2" x 2" vaginal film containing 30 mg of MK-2048 and 41.5 mg of ammonio methacrylate copolymer type B (Eudragit®)', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 12, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abnormal vaginal discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vulvovaginal itching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Unexpected vaginal bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vulvovaginal irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bacterial vaginosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vaginal odor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Early menses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vaginal dryness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain, low', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Post-traumatic stress disorder, worsening', 'notes': 'Post-traumatic stress disorder, worsening of pre-existing condition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Grade 2 or Higher Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Eudragit MK-2048 Vaginal Film', 'description': 'Single use of 2" x 2" vaginal film containing 30 mg of MK-2048 and 68.1 mg of ammonio methacrylate copolymer type B (Eudragit®).\n\nMK-2048 High Eudragit Vaginal Film: 2" x 2" vaginal film containing 30 mg of MK-2048 and 68.1 mg of ammonio methacrylate copolymer type B (Eudragit®)'}, {'id': 'OG001', 'title': 'Low Eudragit MK-2048 Vaginal Film', 'description': 'Single use of 2" x 2" vaginal film containing 30 mg of MK-2048 and 41.5 mg of ammonio methacrylate copolymer type B (Eudragit®).\n\nMK-2048 Low Eudragit Vaginal Film: 2" x 2" vaginal film containing 30 mg of MK-2048 and 41.5 mg of ammonio methacrylate copolymer type B (Eudragit®)'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.025', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completion, approximately 28 days', 'description': 'Number of participants who experience Grade 2 or higher adverse events', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration Versus Time Curve of MK-2048', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Eudragit MK-2048 Vaginal Film', 'description': 'Single use of 2" x 2" vaginal film containing 30 mg of MK-2048 and 68.1 mg of ammonio methacrylate copolymer type B (Eudragit®).\n\nMK-2048 High Eudragit Vaginal Film: 2" x 2" vaginal film containing 30 mg of MK-2048 and 68.1 mg of ammonio methacrylate copolymer type B (Eudragit®)'}, {'id': 'OG001', 'title': 'Low Eudragit MK-2048 Vaginal Film', 'description': 'Single use of 2" x 2" vaginal film containing 30 mg of MK-2048 and 41.5 mg of ammonio methacrylate copolymer type B (Eudragit®).\n\nMK-2048 Low Eudragit Vaginal Film: 2" x 2" vaginal film containing 30 mg of MK-2048 and 41.5 mg of ammonio methacrylate copolymer type B (Eudragit®)'}], 'classes': [{'categories': [{'measurements': [{'value': '1370', 'groupId': 'OG000', 'lowerLimit': '706', 'upperLimit': '2435'}, {'value': '1873', 'groupId': 'OG001', 'lowerLimit': '563', 'upperLimit': '3959'}]}]}], 'analyses': [{'pValue': '.47', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Through study completion, approximately 28 days', 'description': 'Area under the plasma concentration versus time curve of MK-2048 reported as pg x day/mL. MK-2048 plasma concentration was measured at 0, 3, 5, 7, 10, 14, and 28 days after film insertion.', 'unitOfMeasure': 'pg x day/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Area Under the Cervical Tissue Homogenate Concentration Versus Time Curve of MK-2048', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Eudragit MK-2048 Vaginal Film', 'description': 'Single use of 2" x 2" vaginal film containing 30 mg of MK-2048 and 68.1 mg of ammonio methacrylate copolymer type B (Eudragit®).\n\nMK-2048 High Eudragit Vaginal Film: 2" x 2" vaginal film containing 30 mg of MK-2048 and 68.1 mg of ammonio methacrylate copolymer type B (Eudragit®)'}, {'id': 'OG001', 'title': 'Low Eudragit MK-2048 Vaginal Film', 'description': 'Single use of 2" x 2" vaginal film containing 30 mg of MK-2048 and 41.5 mg of ammonio methacrylate copolymer type B (Eudragit®).\n\nMK-2048 Low Eudragit Vaginal Film: 2" x 2" vaginal film containing 30 mg of MK-2048 and 41.5 mg of ammonio methacrylate copolymer type B (Eudragit®)'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'MK 2048 levels in all tissue homogenate samples were below the limit of quantitation for the assay.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'MK 2048 levels in all tissue homogenate samples were below the limit of quantitation for the assay.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Through study completion, approximately 28 days', 'description': 'Area under the cervical tissue homogenate concentration versus time curve of MK-2048 reported as pg x day/mL. MK-2048 concentration was measured at 0, 3, 5, 7, 10, 14, and 28 days after film insertion.', 'unitOfMeasure': 'pg x day/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'MK 2048 levels in all tissue homogenate samples were below the limit of quantitation for the assay. Therefore, the area under the curve could not be calculated.'}, {'type': 'SECONDARY', 'title': 'Area Under the Cervicovaginal Lavage Fluid Concentration Versus Time Curve of MK-2048', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Eudragit MK-2048 Vaginal Film', 'description': 'Single use of 2" x 2" vaginal film containing 30 mg of MK-2048 and 68.1 mg of ammonio methacrylate copolymer type B (Eudragit®).\n\nMK-2048 High Eudragit Vaginal Film: 2" x 2" vaginal film containing 30 mg of MK-2048 and 68.1 mg of ammonio methacrylate copolymer type B (Eudragit®)'}, {'id': 'OG001', 'title': 'Low Eudragit MK-2048 Vaginal Film', 'description': 'Single use of 2" x 2" vaginal film containing 30 mg of MK-2048 and 41.5 mg of ammonio methacrylate copolymer type B (Eudragit®).\n\nMK-2048 Low Eudragit Vaginal Film: 2" x 2" vaginal film containing 30 mg of MK-2048 and 41.5 mg of ammonio methacrylate copolymer type B (Eudragit®)'}], 'timeFrame': 'Through study completion, approximately 28 days', 'description': 'Area under the cervicovaginal lavage fluid concentration versus time curve of MK-2048 reported as pg x day/mL', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected'}, {'type': 'SECONDARY', 'title': 'Area Under the Rectal Swab Eluent Concentration Versus Time Curve of MK-2048', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Eudragit MK-2048 Vaginal Film', 'description': 'Single use of 2" x 2" vaginal film containing 30 mg of MK-2048 and 68.1 mg of ammonio methacrylate copolymer type B (Eudragit®).\n\nMK-2048 High Eudragit Vaginal Film: 2" x 2" vaginal film containing 30 mg of MK-2048 and 68.1 mg of ammonio methacrylate copolymer type B (Eudragit®)'}, {'id': 'OG001', 'title': 'Low Eudragit MK-2048 Vaginal Film', 'description': 'Single use of 2" x 2" vaginal film containing 30 mg of MK-2048 and 41.5 mg of ammonio methacrylate copolymer type B (Eudragit®).\n\nMK-2048 Low Eudragit Vaginal Film: 2" x 2" vaginal film containing 30 mg of MK-2048 and 41.5 mg of ammonio methacrylate copolymer type B (Eudragit®)'}], 'timeFrame': 'Through study completion, approximately 28 days', 'description': 'Area under the rectal swab eluent concentration versus time curve of MK-2048 reported as pg x day/mL', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected'}, {'type': 'SECONDARY', 'title': 'Area Under the Vaginal Swab Eluent Concentration Versus Time Curve of MK-2048', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Eudragit MK-2048 Vaginal Film', 'description': 'Single use of 2" x 2" vaginal film containing 30 mg of MK-2048 and 68.1 mg of ammonio methacrylate copolymer type B (Eudragit®).\n\nMK-2048 High Eudragit Vaginal Film: 2" x 2" vaginal film containing 30 mg of MK-2048 and 68.1 mg of ammonio methacrylate copolymer type B (Eudragit®)'}, {'id': 'OG001', 'title': 'Low Eudragit MK-2048 Vaginal Film', 'description': 'Single use of 2" x 2" vaginal film containing 30 mg of MK-2048 and 41.5 mg of ammonio methacrylate copolymer type B (Eudragit®).\n\nMK-2048 Low Eudragit Vaginal Film: 2" x 2" vaginal film containing 30 mg of MK-2048 and 41.5 mg of ammonio methacrylate copolymer type B (Eudragit®)'}], 'classes': [{'categories': [{'measurements': [{'value': '543608', 'groupId': 'OG000', 'lowerLimit': '50535', 'upperLimit': '3256911'}, {'value': '1112355', 'groupId': 'OG001', 'lowerLimit': '58319', 'upperLimit': '1642201'}]}]}], 'analyses': [{'pValue': '.67', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Through study completion, approximately 28 days', 'description': 'Area under the vaginal swab eluent concentration versus time curve of MK-2048 reported as ng x day/mL. MK-2048 concentration was measured at 0, 3, 5, 7, 10, 14, and 28 days after film insertion.', 'unitOfMeasure': 'ng x day/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Median Fold Change in Percent Inhibition of Human Immunodeficiency Virus-1 Replication in Cervicovaginal Lavage Fluid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Eudragit MK-2048 Vaginal Film', 'description': 'Single use of 2" x 2" vaginal film containing 30 mg of MK-2048 and 68.1 mg of ammonio methacrylate copolymer type B (Eudragit®).\n\nMK-2048 High Eudragit Vaginal Film: 2" x 2" vaginal film containing 30 mg of MK-2048 and 68.1 mg of ammonio methacrylate copolymer type B (Eudragit®)'}, {'id': 'OG001', 'title': 'Low Eudragit MK-2048 Vaginal Film', 'description': 'Single use of 2" x 2" vaginal film containing 30 mg of MK-2048 and 41.5 mg of ammonio methacrylate copolymer type B (Eudragit®).\n\nMK-2048 Low Eudragit Vaginal Film: 2" x 2" vaginal film containing 30 mg of MK-2048 and 41.5 mg of ammonio methacrylate copolymer type B (Eudragit®)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.01', 'groupId': 'OG000', 'lowerLimit': '.13', 'upperLimit': '1.25'}, {'value': '.92', 'groupId': 'OG001', 'lowerLimit': '.09', 'upperLimit': '1.11'}]}]}], 'analyses': [{'pValue': '.51', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Through study completion, approximately 28 days', 'description': 'Median fold change in in-vitro anti-human immunodeficiency virus-1 activity in cervicovaginal lavage fluid determined by the TZM-bl assay and defined as percent inhibition of human immunodeficiency virus-1 infection by luciferase for a single round of replication measured at day 28 divided by percent inhibition measured at baseline.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with a cervical biopsy sample taken. Two participants in the low Eudragit arm did not have cervical biopsies performed due to product discontinuation. One participant in the high arm also did not have a cervical biopsy collected due to safety concerns since she did not refrain from sexual activity prior to the visit.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Human Immunodeficiency Virus-1 p24 Core Protein Titer in Cervical Biopsies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Eudragit MK-2048 Vaginal Film', 'description': 'Single use of 2" x 2" vaginal film containing 30 mg of MK-2048 and 68.1 mg of ammonio methacrylate copolymer type B (Eudragit®).\n\nMK-2048 High Eudragit Vaginal Film: 2" x 2" vaginal film containing 30 mg of MK-2048 and 68.1 mg of ammonio methacrylate copolymer type B (Eudragit®)'}, {'id': 'OG001', 'title': 'Low Eudragit MK-2048 Vaginal Film', 'description': 'Single use of 2" x 2" vaginal film containing 30 mg of MK-2048 and 41.5 mg of ammonio methacrylate copolymer type B (Eudragit®).\n\nMK-2048 Low Eudragit Vaginal Film: 2" x 2" vaginal film containing 30 mg of MK-2048 and 41.5 mg of ammonio methacrylate copolymer type B (Eudragit®)'}], 'classes': [{'categories': [{'measurements': [{'value': '96.0', 'groupId': 'OG000', 'lowerLimit': '17.1', 'upperLimit': '1210.5'}, {'value': '543.5', 'groupId': 'OG001', 'lowerLimit': '265.0', 'upperLimit': '9050.2'}]}]}], 'analyses': [{'pValue': '.09', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Through study completion, approximately 28 days', 'description': 'Human Immunodeficiency Virus-1 infection of cervical biopsies as defined as titer of the HIV-1 p24 core protein measured by ELISA and expressed as log10 pg/mL per mg of tissue', 'unitOfMeasure': 'log10 pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': "All participants with a cervical biopsy sample taken. Two participants in the low Eudragit arm did not have cervical biopsies performed due to product discontinuation. One participant in the high Eudragit arm did not have a cervical biopsy collected due to safety concerns since she did not remain sexually abstinence prior to the visit and one participant's biopsy p24 results are not evaluable due to a lab processing error."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Change in Nugent Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Eudragit MK-2048 Vaginal Film', 'description': 'Single use of 2" x 2" vaginal film containing 30 mg of MK-2048 and 68.1 mg of ammonio methacrylate copolymer type B (Eudragit®).\n\nMK-2048 High Eudragit Vaginal Film: 2" x 2" vaginal film containing 30 mg of MK-2048 and 68.1 mg of ammonio methacrylate copolymer type B (Eudragit®)'}, {'id': 'OG001', 'title': 'Low Eudragit MK-2048 Vaginal Film', 'description': 'Single use of 2" x 2" vaginal film containing 30 mg of MK-2048 and 41.5 mg of ammonio methacrylate copolymer type B (Eudragit®).\n\nMK-2048 Low Eudragit Vaginal Film: 2" x 2" vaginal film containing 30 mg of MK-2048 and 41.5 mg of ammonio methacrylate copolymer type B (Eudragit®)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.35', 'groupId': 'OG000', 'lowerLimit': '-0.93', 'upperLimit': '0.24'}, {'value': '-0.62', 'groupId': 'OG001', 'lowerLimit': '-1.71', 'upperLimit': '0.48'}]}]}], 'analyses': [{'pValue': '.65', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '.24', 'groupIds': ['OG000'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '.27', 'groupIds': ['OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Through study completion, approximately 28 days', 'description': 'Mean change in the Nugent score as determined from vaginal smears. Nugent scores range from 0 to 10; 0 indicates a Lactobacillus-dominant microbiome while a score of 10 indicates a microbiome dominated by bacterial vaginosis-associated bacteria. Nugent scores were assessed at 0, 3, 5, 7, 10, 14, and 28 days after film insertion. The mean change was estimated from a mixed effects linear regression model and is defined as the average change between each post-insertion time point and the pre-insertion time point.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who had Nugent scores assessed at enrollment and at one or more follow-up visits. The 2 women who discontinued product in the low Eudragit arm were only followed for safety and did not have urogenital samples collected beyond the enrollment visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'High Eudragit MK-2048 Vaginal Film', 'description': 'Single use of 2" x 2" vaginal film containing 30 mg of MK-2048 and 68.1 mg of ammonio methacrylate copolymer type B (Eudragit®).\n\nMK-2048 High Eudragit Vaginal Film: 2" x 2" vaginal film containing 30 mg of MK-2048 and 68.1 mg of ammonio methacrylate copolymer type B (Eudragit®)'}, {'id': 'FG001', 'title': 'Low Eudragit MK-2048 Vaginal Film', 'description': 'Single use of 2" x 2" vaginal film containing 30 mg of MK-2048 and 41.5 mg of ammonio methacrylate copolymer type B (Eudragit®).\n\nMK-2048 Low Eudragit Vaginal Film: 2" x 2" vaginal film containing 30 mg of MK-2048 and 41.5 mg of ammonio methacrylate copolymer type B (Eudragit®)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Cervical biopsy not performed since participant did not refrain from sexual activity', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'High Eudragit MK-2048 Vaginal Film', 'description': 'Single use of 2" x 2" vaginal film containing 30 mg of MK-2048 and 68.1 mg of ammonio methacrylate copolymer type B (Eudragit®).\n\nMK-2048 High Eudragit Vaginal Film: 2" x 2" vaginal film containing 30 mg of MK-2048 and 68.1 mg of ammonio methacrylate copolymer type B (Eudragit®)'}, {'id': 'BG001', 'title': 'Low Eudragit MK-2048 Vaginal Film', 'description': 'Single use of 2" x 2" vaginal film containing 30 mg of MK-2048 and 41.5 mg of ammonio methacrylate copolymer type B (Eudragit®).\n\nMK-2048 Low Eudragit Vaginal Film: 2" x 2" vaginal film containing 30 mg of MK-2048 and 41.5 mg of ammonio methacrylate copolymer type B (Eudragit®)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '26.6', 'spread': '6.9', 'groupId': 'BG000'}, {'value': '28.2', 'spread': '5.5', 'groupId': 'BG001'}, {'value': '27.2', 'spread': '6.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic, white', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Non-Hispanic, white', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}, {'title': 'Non-Hispanic, black', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Bi-/multi-racial', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic, not otherwise specified', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Has current sexual partner', 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-04-23', 'size': 1907349, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-12-15T17:03', 'hasProtocol': True}, {'date': '2021-12-14', 'size': 332411, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-04-04T16:53', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-01', 'studyFirstSubmitDate': '2020-03-17', 'resultsFirstSubmitDate': '2023-01-03', 'studyFirstSubmitQcDate': '2020-03-20', 'lastUpdatePostDateStruct': {'date': '2023-03-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-03-01', 'studyFirstPostDateStruct': {'date': '2020-03-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Median Fold Change in Percent Inhibition of Human Immunodeficiency Virus-1 Replication in Cervicovaginal Lavage Fluid', 'timeFrame': 'Through study completion, approximately 28 days', 'description': 'Median fold change in in-vitro anti-human immunodeficiency virus-1 activity in cervicovaginal lavage fluid determined by the TZM-bl assay and defined as percent inhibition of human immunodeficiency virus-1 infection by luciferase for a single round of replication measured at day 28 divided by percent inhibition measured at baseline.'}, {'measure': 'Human Immunodeficiency Virus-1 p24 Core Protein Titer in Cervical Biopsies', 'timeFrame': 'Through study completion, approximately 28 days', 'description': 'Human Immunodeficiency Virus-1 infection of cervical biopsies as defined as titer of the HIV-1 p24 core protein measured by ELISA and expressed as log10 pg/mL per mg of tissue'}, {'measure': 'Mean Change in Nugent Score', 'timeFrame': 'Through study completion, approximately 28 days', 'description': 'Mean change in the Nugent score as determined from vaginal smears. Nugent scores range from 0 to 10; 0 indicates a Lactobacillus-dominant microbiome while a score of 10 indicates a microbiome dominated by bacterial vaginosis-associated bacteria. Nugent scores were assessed at 0, 3, 5, 7, 10, 14, and 28 days after film insertion. The mean change was estimated from a mixed effects linear regression model and is defined as the average change between each post-insertion time point and the pre-insertion time point.'}], 'primaryOutcomes': [{'measure': 'Number of Participants With Grade 2 or Higher Adverse Events', 'timeFrame': 'Through study completion, approximately 28 days', 'description': 'Number of participants who experience Grade 2 or higher adverse events'}], 'secondaryOutcomes': [{'measure': 'Area Under the Plasma Concentration Versus Time Curve of MK-2048', 'timeFrame': 'Through study completion, approximately 28 days', 'description': 'Area under the plasma concentration versus time curve of MK-2048 reported as pg x day/mL. MK-2048 plasma concentration was measured at 0, 3, 5, 7, 10, 14, and 28 days after film insertion.'}, {'measure': 'Area Under the Cervical Tissue Homogenate Concentration Versus Time Curve of MK-2048', 'timeFrame': 'Through study completion, approximately 28 days', 'description': 'Area under the cervical tissue homogenate concentration versus time curve of MK-2048 reported as pg x day/mL. MK-2048 concentration was measured at 0, 3, 5, 7, 10, 14, and 28 days after film insertion.'}, {'measure': 'Area Under the Cervicovaginal Lavage Fluid Concentration Versus Time Curve of MK-2048', 'timeFrame': 'Through study completion, approximately 28 days', 'description': 'Area under the cervicovaginal lavage fluid concentration versus time curve of MK-2048 reported as pg x day/mL'}, {'measure': 'Area Under the Rectal Swab Eluent Concentration Versus Time Curve of MK-2048', 'timeFrame': 'Through study completion, approximately 28 days', 'description': 'Area under the rectal swab eluent concentration versus time curve of MK-2048 reported as pg x day/mL'}, {'measure': 'Area Under the Vaginal Swab Eluent Concentration Versus Time Curve of MK-2048', 'timeFrame': 'Through study completion, approximately 28 days', 'description': 'Area under the vaginal swab eluent concentration versus time curve of MK-2048 reported as ng x day/mL. MK-2048 concentration was measured at 0, 3, 5, 7, 10, 14, and 28 days after film insertion.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vagina', 'Film', 'Extended Release'], 'conditions': ['Pharmacokinetics', 'Safety']}, 'descriptionModule': {'briefSummary': 'This is a proof of concept study to determine whether an extended release vaginal film can deliver drug for seven days. Two film formulations containing MK-2048 which differ by dissolution and spreadability attributes will be compared for safety and pharmacokinetic outcomes.', 'detailedDescription': 'This is a phase I randomized trial assessing the safety, acceptability, and pharmacokinetics of two formulations of MK-2048 vaginal film. While the primary objective is to evaluate the safety of the product, the overarching objective of this study is to provide proof of concept that an antiretroviral drug can be delivered in an extended release film formulation to provide drug delivery for 7 days or more after a single application. Forty eight women will be randomized with equal frequency to receive a single dose of a vaginal film containing MK-2048 (either the high Eudragit® or low Eudragit® formulation). The film will be inserted by a clinician on the day of enrollment. Vaginal swabs and plasma will be collected at days 0, 3, 5, 7, 10, 14 and 28 for all participants. On the day of enrollment, some participants may elect to participate in immediate post insertion sample collection (vaginal swab and plasma) at one or two time points within 6 hours of insertion. Genital biopsy samples and a rectal swab will be obtained on day 7, and cervicovaginal lavage will be collected at screening and days 14 and 28. The primary endpoint is the frequency of Grade 2 or higher adverse events. The secondary endpoints are: MK-2048 concentrations in plasma, cervical tissue homogenate, cervicovaginal lavage fluid, rectal and vaginal swab eluents; self-reported assessment of qualities of the experience with the films drawn from existing survey on microbicidal films, and general acceptability ratings drawn from market research methodology.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able and willing to provide written informed consent.\n* Willing to use an effective method of birth control throughout the duration of the study. Examples of effective methods include: hormonal methods (other than NuvaRing®), intrauterine device, bilateral tubal ligation, same sex partner, partner with a vasectomy, abstinence (defined as no vaginal sex for one month prior to screening).\n* Able and willing to provide adequate locator information\n* HIV-uninfected based on testing performed by study staff at screening\n* In general good health as determined by the site clinician\n* Agree to be sexually abstinent, including use of sex toys, from visit 2 (Enrollment) until visit 7 (7 days after the biopsy visit) and 48 hours prior to all study visits.\n* Agree to refrain from use of vaginal device or products (for example, lubricants, creams, suppositories) throughout participation in the study. Tampons may be used except between visit 5 (biopsy visit) and visit 7 (day 14).\n* Willingness to undergo all study-related assessments and follow all study-related procedures\n* At screening and enrollment, agrees not to participate in other research studies involving drugs, medical devices, or vaginal products while enrolled in this trial\n* Participants over the age of 21 (inclusive) must have documentation of a satisfactory Pap within three years prior to Enrollment consistent with Grade 0 according to the Female Genital Grading Table for Use in Microbicide Studies Addendum 1 (Dated November 2007) to the Division of Acquired Immune Deficiency Syndrome Table for Grading Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017, or satisfactory evaluation with no treatment required of grade 1 or higher Pap results. If no documentation of a Pap smear can be provided, a Pap smear will be collected at the screening visit.\n\nExclusion Criteria:\n\n* Menopause (as defined as amenorrhea for one year or more without an alternative etiology)\n* Hysterectomy\n* Participant report of any of the following:\n\n 1. Known adverse reaction to any of the study products (ever)\n 2. Non- therapeutic injection drug use in the 12 months prior to Screening\n 3. Surgical procedure involving the pelvis in the 60 days prior to enrollment (includes dilation and curettage or evacuation, and cryosurgery; does not include cervical biopsy for evaluation of an abnormal pap smear)\n 4. Participation in a drug, spermicide and/or microbicide study in the 30 days prior to enrollment\n 5. Currently pregnant or pregnancy within 42 days prior to enrollment\n 6. Currently lactating\n 7. Use of a diaphragm, NuvaRing®, or spermicide for contraception\n* Urogenital infection or suspected infection within 7 days of enrollment including: symptomatic candidiasis, trichomonas vaginalis, and symptomatic bacterial vaginosis; or cervical infection, including N. gonorrhoeae, C. trachomatis, or mucopurulent cervicitis; syphilis; herpes simplex virus lesions, or other sores (Note: seropositive herpes simplex virus without active lesions will not be excluded); acute pelvic inflammatory disease; urinary tract infection; recent exposure to a partner with N. gonorrhoeae, C. trachomatis, Trichomonas, syphilis, or non-gonorrheal urethritis\n* Antibiotic or antifungal therapy (vaginal or systemic) within 7 days of enrollment\n* As determined by the primary investigator, has any significant uncontrolled active or chronic cardiovascular, renal, liver, hematologic, neurologic, gastrointestinal, psychiatric, endocrine \\*including poorly controlled diabetes), respiratory, immunologic disorder or infectious disease\n* Menses-like bleeding at the time of the Enrollment visit\\* or expected menses-like bleeding within 14 days of the Enrollment visit (\\*Women who have vaginal bleeding at the scheduled Enrollment visit may return at a different date to be re-examined and possibly enrolled provided they are still within the screening window and meet all criteria.)\n* Any condition that, in the opinion of the Investigator, would preclude provision of consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives'}, 'identificationModule': {'nctId': 'NCT04319718', 'acronym': 'FAME103', 'briefTitle': 'Safety and Pharmacokinetics of Two Vaginal Film Formulations Containing the Integrase Inhibitor MK-2048', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'A Randomized, Double Blinded Study of the Safety and Pharmacokinetics of Two Vaginal Film Formulations Containing the Integrase Inhibitor MK-2048', 'orgStudyIdInfo': {'id': 'STUDY19100120'}, 'secondaryIdInfos': [{'id': '1U19AI120249', 'link': 'https://reporter.nih.gov/quickSearch/1U19AI120249', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'High Eudragit MK-2048 vaginal film', 'description': 'Single use of 2" x 2" vaginal film containing 30 mg of MK-2048 and 68.1 mg of ammonio methacrylate copolymer type B (Eudragit®).', 'interventionNames': ['Combination Product: MK-2048 High Eudragit Vaginal Film']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low Eudragit MK-2048 vaginal film', 'description': 'Single use of 2" x 2" vaginal film containing 30 mg of MK-2048 and 41.5 mg of ammonio methacrylate copolymer type B (Eudragit®).', 'interventionNames': ['Combination Product: MK-2048 Low Eudragit Vaginal Film']}], 'interventions': [{'name': 'MK-2048 High Eudragit Vaginal Film', 'type': 'COMBINATION_PRODUCT', 'description': '2" x 2" vaginal film containing 30 mg of MK-2048 and either 68.1 mg of ammonio methacrylate copolymer type B (Eudragit®)', 'armGroupLabels': ['High Eudragit MK-2048 vaginal film']}, {'name': 'MK-2048 Low Eudragit Vaginal Film', 'type': 'COMBINATION_PRODUCT', 'description': '2" x 2" vaginal film containing 30 mg of MK-2048 and 41.5 mg of ammonio methacrylate copolymer type B (Eudragit®)', 'armGroupLabels': ['Low Eudragit MK-2048 vaginal film']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Magee-Womens Hospital of UPMC', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Katherine Bunge, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}, {'name': 'Sharon L Hillier, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillier, Sharon, PhD', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Katherine Bunge', 'investigatorAffiliation': 'University of Pittsburgh'}}}}