Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-26 @ 2:01 AM
Study NCT ID:
NCT04860505
Status:
COMPLETED
Last Update Posted:
2023-05-23
First Post:
2021-04-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Combo-PEP: Multipurpose Prevention of Post-Exposure Prophylaxis Regimens
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}], 'ancestors': [{'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004318', 'term': 'Doxycycline'}, {'id': 'C000654125', 'term': 'bictegravir, emtricitabine, tenofovir alafenamide, drug combination'}], 'ancestors': [{'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'colleen.kelley@emory.edu', 'phone': '404-712-1823', 'title': 'Dr. Colleen Kelley', 'organization': 'Emory University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Information on adverse events was collected beginning at the time of enrollment until the participants completed the study or withdrew from the study, up to 7 days.', 'eventGroups': [{'id': 'EG000', 'title': 'Doxycycline and Biktarvy', 'description': 'Participants took both study drugs simultaneously at home and came to the clinic for a study visit the following day for samples to be obtained 24 hours after the single dose of study drugs.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Rectal Doxycycline Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Doxycycline and Biktarvy', 'description': 'Participants took both study drugs simultaneously at home and came to the clinic for a study visit the following day for samples to be obtained 24 hours after the single dose of study drugs.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.654', 'groupId': 'OG000', 'lowerLimit': '0.305', 'upperLimit': '1.237'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24 hours after a single dose', 'description': 'Doxycycline concentration in tissue from a rectal biopsy was measured. Rectal biopsies were obtained from men. Women had the option to provide a rectal tissue sample.', 'unitOfMeasure': 'µg/g', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who completed the rectal biopsy during the 24-hours post-dose visit. Ten men and 5 women provided rectal tissue samples at the 24-hours post-dose visit. One male attended the visit but was not able to tolerate the biopsy procedure and no rectal tissue was obtained.'}, {'type': 'PRIMARY', 'title': 'Vaginal Doxycycline Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Doxycycline and Biktarvy', 'description': 'Participants took both study drugs simultaneously at home and came to the clinic for a study visit the following day for samples to be obtained 24 hours after the single dose of study drugs.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.367', 'groupId': 'OG000', 'lowerLimit': '0.203', 'upperLimit': '1.445'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24 hours after a single dose', 'description': 'Doxycycline concentration in tissue from a vaginal biopsy was measured.', 'unitOfMeasure': 'µg/g', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'One female attended the visit 24 hours post-dose but was not able to proceed with the vaginal biopsy procedure due to menses and vaginal rugae.'}, {'type': 'PRIMARY', 'title': 'Plasma Doxycycline Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Doxycycline and Biktarvy', 'description': 'Participants took both study drugs simultaneously at home and came to the clinic for a study visit the following day for samples to be obtained 24 hours after the single dose of study drugs.'}], 'classes': [{'categories': [{'measurements': [{'value': '487', 'groupId': 'OG000', 'lowerLimit': '305', 'upperLimit': '824'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24 hours after a single dose', 'description': 'Doxycycline concentration in plasma was measured.', 'unitOfMeasure': 'µg/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rectal Bictegravir Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Doxycycline and Biktarvy', 'description': 'Participants took both study drugs simultaneously at home and came to the clinic for a study visit the following day for samples to be obtained 24 hours after the single dose of study drugs.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.085', 'comment': 'The lowest value is below the limit of detection of 0.010.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': '0.391'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24 hours after a single dose', 'description': 'Bectegravir concentration in tissue from a rectal biopsy was measured.', 'unitOfMeasure': 'µg/g', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who completed the rectal biopsy during the 24-hours post-dose visit. Ten men and 5 women provided rectal tissue samples at the 24-hours post-dose visit. One male attended the visit but was not able to tolerate the biopsy procedure and no rectal tissue was obtained.'}, {'type': 'SECONDARY', 'title': 'Vaginal Bictegravir Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Doxycycline and Biktarvy', 'description': 'Participants took both study drugs simultaneously at home and came to the clinic for a study visit the following day for samples to be obtained 24 hours after the single dose of study drugs.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.207', 'comment': 'The lowest value is below the limit of detection of 0.010.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': '1.038'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24 hours after a single dose', 'description': 'Bictegravir concentration in tissue from a vaginal biopsy was measured.', 'unitOfMeasure': 'µg/g', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'One female attended the visit 24 hours post-dose but was not able to proceed with the vaginal biopsy procedure due to menses and vaginal rugae.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Doxycycline and Biktarvy', 'description': 'Participants took both study drugs simultaneously at home and came to the clinic for a study visit the following day for samples to be obtained 24 hours after the single dose of study drugs.\n\nDoxycycline (DOX \\[200 mg\\]) is an oral medication used to treat or prevent infections that are strongly suspected to be caused by bacteria; it is an antimicrobial drug indicated for bacterial infections such as sexually transmitted infections.\n\nBiktarvy (200mg) is an oral combination anti-HIV medication that contains the drugs tenofovir alafenamide, emtricitabine, and bictegravir.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'Attended 24 Hours Post-dose Visit', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'comment': 'Completed 7 days post-dose visit', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Participants were recruited from the Hope Clinic in Atlanta, Georgia, USA. Participant enrollment began May 20, 2021 and all follow-up assessments were completed by May 9, 2022.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Doxycycline and Biktarvy', 'description': 'Participants took both study drugs simultaneously at home and came to the clinic for a study visit the following day for samples to be obtained 24 hours after the single dose of study drugs.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-09-13', 'size': 612044, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-03-27T16:19', 'hasProtocol': True}, {'date': '2022-02-22', 'size': 317475, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-04-26T13:43', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-05-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-26', 'studyFirstSubmitDate': '2021-04-22', 'resultsFirstSubmitDate': '2023-04-22', 'studyFirstSubmitQcDate': '2021-04-22', 'lastUpdatePostDateStruct': {'date': '2023-05-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-04-26', 'studyFirstPostDateStruct': {'date': '2021-04-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rectal Doxycycline Concentration', 'timeFrame': '24 hours after a single dose', 'description': 'Doxycycline concentration in tissue from a rectal biopsy was measured. Rectal biopsies were obtained from men. Women had the option to provide a rectal tissue sample.'}, {'measure': 'Vaginal Doxycycline Concentration', 'timeFrame': '24 hours after a single dose', 'description': 'Doxycycline concentration in tissue from a vaginal biopsy was measured.'}, {'measure': 'Plasma Doxycycline Concentration', 'timeFrame': '24 hours after a single dose', 'description': 'Doxycycline concentration in plasma was measured.'}], 'secondaryOutcomes': [{'measure': 'Rectal Bictegravir Concentration', 'timeFrame': '24 hours after a single dose', 'description': 'Bectegravir concentration in tissue from a rectal biopsy was measured.'}, {'measure': 'Vaginal Bictegravir Concentration', 'timeFrame': '24 hours after a single dose', 'description': 'Bictegravir concentration in tissue from a vaginal biopsy was measured.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Post-Exposure Prophylaxis', 'HIV', 'STI', 'PEP', 'Prevention'], 'conditions': ['Sexually Transmitted Diseases']}, 'descriptionModule': {'briefSummary': 'The study will determine tissue pharmacology of a single dose of doxycycline for sexually transmitted infection (STI) Post-exposure Prophylaxis (PEP).', 'detailedDescription': 'To determine tissue pharmacology of a single dose of doxycycline for STI PEP, investigators at Emory University will collaborate with the Centers for Disease Control and Prevention (CDC) to conduct a clinical trial of up to 20 men who have sex with men (MSM) and women aged 18-59, with measurement of anti-retroviral drug and doxycycline concentrations in the rectum and vaginal regions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. HIV negative person, who was assigned male or female at birth, who reports sex with another man in the last year and is in good general health\n2. Aged 18-59 years\n3. Not currently taking PrEP and no plans to initiate during study\n4. Not currently taking PEP\n5. Not currently taking doxycycline or other tetracycline-derived antibiotics and no plans to initiate during the study\n6. Willing to use condoms consistently for the duration of the study\n7. Able to provide informed consent in English\n8. No plans for relocation in the next 4 months\n9. Willing to undergo peripheral blood, urine, rectal or vaginal secretion collection, and a rectal or vaginal and cervical biopsy procedure\n10. Willing to use study products as directed\n11. Hepatitis B surface antigen (HBsAg) negative (screening lab test)\n12. Creatinine clearance \\>60 ml/min\n\nExclusion Criteria:\n\n1. Currently infected with hepatitis virus and/ or has liver disease\n2. Current or chronic history of kidney disease or creatinine clearance (CrCl)\\<60 ml/min\n3. Continued need for, or use during the 90 days prior to enrollment, of the following medications:\n\n 1. Systemic immunomodulatory agents\n 2. Supraphysiologic doses of steroids (short course steroids less than 7 days duration, allowable at the discretion of the investigators)\n 3. Chemotherapy or radiation for treatment of malignancy\n 4. Experimental medications, vaccines, or biologicals\n4. Intent to use HIV antiretroviral pre/post-exposure prophylaxis (PrEP or PEP) during the study, outside of the study procedures\n5. Intent to use doxycycline or other tetracycline-derived antibiotics during the course of the study, outside of the study procedures\n6. Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study requirements\n7. Not pregnant and no plans on getting pregnant throughout the duration of the study\n8. Known allergic reaction to study drugs'}, 'identificationModule': {'nctId': 'NCT04860505', 'briefTitle': 'Combo-PEP: Multipurpose Prevention of Post-Exposure Prophylaxis Regimens', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Combo-PEP: Multipurpose Prevention of Post-Exposure Prophylaxis Regimens', 'orgStudyIdInfo': {'id': 'STUDY00002242'}, 'secondaryIdInfos': [{'id': '0000058968', 'type': 'OTHER_GRANT', 'domain': 'CDC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Doxycycline and Biktarvy', 'description': 'Participants will take both study drugs simultaneously at home approximately 1 hour before Visit 2 and will be instructed to take a timestamped photograph or videotape of themselves taking the dose.', 'interventionNames': ['Drug: Doxycycline', 'Drug: Biktarvy']}], 'interventions': [{'name': 'Doxycycline', 'type': 'DRUG', 'description': 'Doxycycline (DOX \\[200 mg\\]) is an oral medication used to treat or prevent infections that are strongly suspected to be caused by bacteria; it is an antimicrobial drug indicated for bacterial infections such as sexually transmitted infections.', 'armGroupLabels': ['Doxycycline and Biktarvy']}, {'name': 'Biktarvy', 'type': 'DRUG', 'description': 'Biktarvy (200mg) is an oral combination anti-HIV medication that contains the drugs tenofovir alafenamide, emtricitabine, and bictegravir.', 'armGroupLabels': ['Doxycycline and Biktarvy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Hope Clinic', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Colleen Kelley, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data will be made available to researchers providing a methodologically sound proposal, beginning 9 months and ending 36 months following publication.', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results published for this study (including text, tables, figures, and appendices), will be made available for sharing, after de-identification.', 'accessCriteria': 'Proposals should be directed to colleen.kelley@emory.edu. To gain access, data requestors will need to sign a data access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centers for Disease Control and Prevention', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Colleen Kelley', 'investigatorAffiliation': 'Emory University'}}}}