Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-31 @ 12:40 PM
Study NCT ID:
NCT07055451
Status:
RECRUITING
Last Update Posted:
2025-12-02
First Post:
2025-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Newborns Exposed to HIV
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-01', 'studyFirstSubmitDate': '2025-06-27', 'studyFirstSubmitQcDate': '2025-06-27', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAs) Though Week 8 After Neonate Birth', 'timeFrame': 'First dose date up to 8 Weeks'}, {'measure': 'Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities Through Week 8 After Neonate Birth', 'timeFrame': 'First dose date up to 8 Weeks'}, {'measure': 'Pharmacokinetic (PK) parameters for Bictegravir (BIC): AUCinf', 'timeFrame': 'Predose up to 72 hours postdose', 'description': 'AUCinf is defined as area under the concentration versus time curve extrapolated to infinite time.'}, {'measure': 'PK parameters for BIC: AUClast', 'timeFrame': 'Predose up to 72 hours postdose', 'description': 'AUClast is defined as the area under the concentration versus time curve from time zero to the last quantifiable concentration.'}, {'measure': 'PK parameters for BIC: AUC0-24h', 'timeFrame': 'Predose up to 24 hours postdose', 'description': 'AUC0-24h is defined as the partial area under the concentration versus time curve from time 0 to time 24 hours.'}, {'measure': 'PK parameters for BIC: Cmax', 'timeFrame': 'Predose up to 72 hours postdose', 'description': 'Cmax is defined as the maximum observed concentration of drug.'}, {'measure': 'PK parameters for BIC: Tmax', 'timeFrame': 'Predose up to 72 hours postdose', 'description': 'Tmax is defined as the time (observed time point) of Cmax.'}, {'measure': 'PK parameters for BIC: Cmin', 'timeFrame': 'Predose up to 72 hours postdose', 'description': 'Cmin is defined as the minimum observed concentration of drug.'}, {'measure': 'PK parameters for BIC: C24h', 'timeFrame': 'At 24 hours postdose', 'description': 'C24h is defined as the concentration of drug at time 24 hours.'}, {'measure': 'PK parameters for BIC: t1/2', 'timeFrame': 'Predose up to 72 hours postdose', 'description': 't1/2 is defined as the terminal elimination half-life.'}, {'measure': 'PK parameters for BIC: Apparent CL/F', 'timeFrame': 'Predose up to 72 hours postdose', 'description': 'Apparent CL/F is defined as the apparent total body clearance for extravascular administration.'}, {'measure': 'PK parameters for BIC: Apparent Vz/F', 'timeFrame': 'Predose up to 72 hours postdose', 'description': 'Apparent Vz/F is defined as the apparent volume of distribution based on the terminal phase.'}], 'secondaryOutcomes': [{'measure': 'PK Parameters for Emtricitabine (FTC), and Tenofovir (TFV): AUCinf', 'timeFrame': 'Predose up to 72 hours postdose', 'description': 'AUCinf is defined as the area under the concentration versus time curve extrapolated to infinite time.'}, {'measure': 'PK parameters for FTC, TAF, and TFV: AUClast', 'timeFrame': 'Predose up to 72 hours postdose', 'description': 'AUClast is defined as the area under the concentration versus time curve from time zero to the last quantifiable concentration.'}, {'measure': 'PK parameters for FTC, TAF, and TFV: AUC0-24h', 'timeFrame': 'Predose up to 24 hours postdose', 'description': 'AUC0-24h is defined as the partial area under the concentration versus time curve from time 0 to time 24 hours.'}, {'measure': 'PK parameters for FTC, TAF, and TFV: Cmax', 'timeFrame': 'Predose up to 72 hours postdose', 'description': 'Cmax is defined as the maximum observed concentration of drug.'}, {'measure': 'PK parameters for FTC, TAF, and TFV: Tmax', 'timeFrame': 'Predose up to 72 hours postdose', 'description': 'Tmax is defined as the time (observed time point) of Cmax.'}, {'measure': 'PK parameters for FTC, TAF, and TFV: Cmin', 'timeFrame': 'Predose up to 72 hours postdose', 'description': 'Cmin is defined as the minimum observed concentration of drug.'}, {'measure': 'PK parameters for FTC, TAF, and TFV: C24h', 'timeFrame': 'At 24 hours postdose', 'description': 'C24h is defined as the concentration of drug at time 24 hours.'}, {'measure': 'PK parameters for FTC, TAF, and TFV: t1/2', 'timeFrame': 'Predose up to 72 hours postdose', 'description': 't1/2 is defined as the terminal elimination half-life.'}, {'measure': 'PK parameters for FTC and TAF: Apparent CL/F', 'timeFrame': 'Predose up to 72 hours postdose', 'description': 'Apparent CL/F is defined as the apparent total body clearance for extravascular administration.'}, {'measure': 'PK parameters for FTC and TAF: Apparent Vz/F', 'timeFrame': 'Predose up to 72 hours postdose', 'description': 'Apparent Vz/F is defined as the apparent volume of distribution based on the terminal phase.'}, {'measure': 'Mother/Caregiver Reported Acceptability of B/F/TAF tablet for oral suspension (TOS)', 'timeFrame': 'First dose date up to 15 days', 'description': 'Acceptability assessed by a numeric response between numbers 1-5. Higher scores indicate better acceptability.'}, {'measure': 'Mother/Caregiver Reported Palatability of B/F/TAF tablet for oral suspension (TOS)', 'timeFrame': 'First dose date up to 15 days', 'description': 'Palatability assessed by a numeric response between numbers 1-5. Higher scores indicate better palatability.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV-1-infection']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.gileadclinicaltrials.com/study?nctid=NCT07055451', 'label': 'Gilead Clinical Trials Website'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical study is to learn more about the study drug, Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF), safety, tolerability, and pharmacokinetics (how B/F/TAF is absorbed, modified, distributed, and removed from the body of the participants) in neonates exposed to human immunodeficiency virus type 1 (HIV-1).\n\nThe primary objective of this study is to evaluate the safety and plasma pharmacokinetics (PK) (how B/F/TAF is absorbed, modified, distributed, and removed from the body of the participants) of B/F/TAF tablet for oral suspension (TOS) in full-term neonates exposed to HIV-1 but uninfected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '120 Hours', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\nMother inclusion criteria:\n\n* Be on standard of care (SOC) antiretroviral therapy for human immunodeficiency virus type 1 (HIV-1) treatment.\n* Have confirmed HIV-1 infection based on positive test results obtained from medical records.\n\nNeonate inclusion criteria:\n\n* Be born at term (≥ 37.0 weeks gestational age).\n* Be able to take oral medication.\n* Be ≤ 120 hours of life at enrollment.\n* Have a birth weight ≥ 2.5 kg.\n* Is receiving or plans to receive HIV-1 SOC prophylaxis regimen with 1 antiretroviral (ARV) to prevent perinatal transmission.\n\nKey Exclusion Criteria:\n\nMother exclusion criteria:\n\n* Has a maternal-fetal blood group incompatibility identified by clinically relevant antibody that can cause hemolytic diseases of the neonate.\n* Is breastfeeding or plans to breastfeed while on bictegravir (BIC) or emtricitabine (FTC) containing regimen. Mothers on BIC or FTC containing regimen, but not breastfeeding, can be enrolled in the study.\n\nNeonate exclusion criteria:\n\n* Had prior or expected to require blood exchange transfusion.\n* Is receiving or plans to receive any component of B/F/TAF or dolutegravir as part of their SOC ARV prophylaxis regimen.\n* Has a documented positive HIV-1 nucleic acid test.\n* Has Grade 2 or higher aspartate aminotransferase, total bilirubin, hemoglobin, platelets or creatinine. Has Grade 1 or higher alanine aminotransferase.\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT07055451', 'briefTitle': 'Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Newborns Exposed to HIV', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'A Phase 1b Study to Evaluate the Safety and Pharmacokinetics of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Neonates Exposed to HIV-1', 'orgStudyIdInfo': {'id': 'GS-US-380-5578'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1: Group A of B/F/TAF', 'description': 'Full-term neonate participants, who are exposed to HIV-1 but uninfected, with a weight of ≥ 2.5 kg at birth and their mothers will be assigned to Cohort 1 Group A to evaluate a different pharmacokinetic (PK) sampling scheme than Cohort 1 Group B.\n\nNeonate participants will receive a single dose of B/F/TAF fixed-dose combination 1.88/7.5/0.94 mg tablet for oral suspension administered along with 1 antiretroviral as standard of care postnatal prophylaxis at both Visits 1 and 3.', 'interventionNames': ['Drug: B/F/TAF']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 1: Group B of B/F/TAF', 'description': 'Once enrollment in Cohort 1 Group A is completed, full-term neonate participants, who are exposed to HIV-1 but uninfected, with a weight of ≥ 2.5 kg at birth and their mothers will be assigned to Cohort 1 Group B to evaluate a different PK sampling scheme than Cohort 1 Group A.\n\nParticipants will receive a single dose of B/F/TAF fixed-dose combination 1.88/7.5/0.94 mg tablet for oral suspension administered along with 1 antiretroviral as standard of care postnatal prophylaxis at both Visits 1 and 3.', 'interventionNames': ['Drug: B/F/TAF']}], 'interventions': [{'name': 'B/F/TAF', 'type': 'DRUG', 'description': 'Tablet for oral suspension administered', 'armGroupLabels': ['Cohort 1: Group A of B/F/TAF', 'Cohort 1: Group B of B/F/TAF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Ronald Reagan UCLA Medical Center (inpatient hospital)', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Grady Health System - Ponce de Leon Center', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '38105', 'city': 'Memphis', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'facility': "St Jude Children's Research Hospital", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '7505', 'city': 'Cape Town', 'status': 'RECRUITING', 'country': 'South Africa', 'facility': 'Family Centre for Research with Ubuntu (FAMCRU)', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '1864', 'city': 'Gauteng', 'status': 'RECRUITING', 'country': 'South Africa', 'facility': 'Perinatal HIV Research Unit (PHRU)'}, {'zip': '2001', 'city': 'Johannesburg', 'status': 'RECRUITING', 'country': 'South Africa', 'facility': 'WITS RHI Shandukani Research Centre', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'zip': '4093', 'city': 'KwaZulu - Natal', 'status': 'RECRUITING', 'country': 'South Africa', 'facility': 'Durban International Clinical Research Site, Enhancing Care Foundation'}], 'centralContacts': [{'name': 'Gilead Clinical Study Information Center', 'role': 'CONTACT', 'email': 'GileadClinicalTrials@gilead.com', 'phone': '1-833-445-3230 (GILEAD-0)'}], 'overallOfficials': [{'name': 'Gilead Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gilead Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}