Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-02-25 @ 4:14 AM
Study NCT ID:
NCT06532656
Status:
RECRUITING
Last Update Posted:
2025-10-30
First Post:
2024-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Bictegravir/Lenacapavir in Children and Adolescents With HIV-1
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000730993', 'term': 'lenacapavir'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2028-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-28', 'studyFirstSubmitDate': '2024-07-29', 'studyFirstSubmitQcDate': '2024-07-29', 'lastUpdatePostDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PK Parameter: Cmax of BIC and LEN at Steady State', 'timeFrame': 'Day 1 up to Week 24, as appropriate', 'description': 'Cmax is defined as the maximum observed concentration of drug at steady state.'}, {'measure': 'PK Parameter: AUCtau of BIC and LEN at Steady State', 'timeFrame': 'Day 1 up to Week 24, as appropriate', 'description': 'AUCtau is defined as the area under the concentration versus time curve over the dosing interval at steady state.'}, {'measure': 'PK Parameter: Ctrough of BIC and LEN at Steady State', 'timeFrame': 'Day 1 up to Week 24, as appropriate', 'description': 'Ctrough is defined as the observed drug concentration at the end of the dosing interval at steady state.'}, {'measure': 'Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) Through Week 24', 'timeFrame': 'First dose date up to Week 24'}, {'measure': 'Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Through Week 24', 'timeFrame': 'First dose date up to Week 24'}], 'secondaryOutcomes': [{'measure': 'PK Parameter: AUClast for BIC and LEN at Steady State', 'timeFrame': 'Day 1 up to Week 48, as appropriate', 'description': 'AUClast is defined as the area under the concentration versus time curve from time zero to the last quantifiable concentration at steady state.'}, {'measure': 'PK Parameter: Tmax for BIC and LEN at Steady State', 'timeFrame': 'Day 1 up to Week 48, as appropriate', 'description': 'Tmax is defined as the time (observed time point) of Cmax at steady state.'}, {'measure': 'PK Parameter: Tlast for BIC and LEN at Steady State', 'timeFrame': 'Day 1 up to Week 48, as appropriate', 'description': 'Tlast is defined as the time (observed time point) of Clast at steady state. Clast is defined as the last measurable concentration (above the quantification limit).'}, {'measure': 'PK Parameter: T1/2 for BIC and LEN at Steady State', 'timeFrame': 'Day 1 up to Week 48, as appropriate', 'description': 'T1/2 is defined as the terminal elimination half-life at steady state.'}, {'measure': 'PK Parameter: CL for BIC and LEN at Steady State', 'timeFrame': 'Day 1 up to Week 48, as appropriate', 'description': 'Clearance (CL) is the volume of plasma cleared of drug over a specified time period, at a steady state.'}, {'measure': 'PK Parameter: Vz for BIC and LEN at Steady State', 'timeFrame': 'Day 1 up to Week 48, as appropriate', 'description': 'Volume of distribution (Vz) is defined as the extent to in which the drug is distributed in the body tissue, rather than the plasma, to produce the desired effects at a steady state.'}, {'measure': 'PK Parameter: λz for BIC and LEN at Steady State', 'timeFrame': 'Day 1 up to Week 48, as appropriate', 'description': 'λz is defined as the terminal elimination rate constant, which determines the rate at which the drug will be eliminated from the body after it is absorbed and distributed at a steady state.'}, {'measure': 'Percentage of Participants Experiencing TEAEs Through Week 48', 'timeFrame': 'First dose date up to Week 48'}, {'measure': 'Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Through Week 48', 'timeFrame': 'First does date up to Week 48'}, {'measure': 'Proportion of Participants With Plasma HIV-1 RNA < 50 copies/mL and ≥ 50 copies/mL at Week 24 Based on the United States (US) Food and Drug Administration (FDA)-Defined Snapshot Algorithm', 'timeFrame': 'Week 24'}, {'measure': 'Proportion of Participants With Plasma HIV-1 RNA < 50 copies/mL and ≥ 50 copies/mL at Week 48 Based on the United States FDA-Defined Snapshot Algorithm', 'timeFrame': 'Week 48'}, {'measure': 'Change from Baseline in Clusters of Differentiation 4 (CD4) Cell Counts at Week 24', 'timeFrame': 'Baseline, Week 24'}, {'measure': 'Change from Baseline in CD4 Percentage at Week 24', 'timeFrame': 'Baseline, Week 24'}, {'measure': 'Change from Baseline in CD4 Cell Counts at Week 48', 'timeFrame': 'Baseline, Week 48'}, {'measure': 'Change from Baseline in CD4 Percentage at Week 48', 'timeFrame': 'Baseline, Week 48'}, {'measure': 'Acceptability and Palatability Summary of LEN Oral Loading Dose at Day 1 Assessed by Questionnaire', 'timeFrame': 'Day 1', 'description': 'Palatability and acceptability assessed by a numeric response between numbers 1-5. Higher scores indicate better palatability and acceptability.'}, {'measure': 'Acceptability and Palatability Summary of LEN Oral Loading Dose at Day 2 Assessed by Questionnaire', 'timeFrame': 'Day 2', 'description': 'Palatability and acceptability assessed by a numeric response between numbers 1-5. Higher scores indicate better palatability and acceptability.'}, {'measure': 'Acceptability and Palatability Summary of Oral BIC/LEN Fixed Dose Combination (FDC) at Day 1 Assessed by Questionnaire', 'timeFrame': 'Day 1', 'description': 'Palatability and acceptability assessed by a numeric response between numbers 1-5. Higher scores indicate better palatability and acceptability.'}, {'measure': 'Acceptability and Palatability Summary of Oral BIC/LEN FDC at Week 4 Assessed by Questionnaire', 'timeFrame': 'Week 4', 'description': 'Palatability and acceptability assessed by a numeric response between numbers 1-5. Higher scores indicate better palatability and acceptability.'}, {'measure': 'Acceptability and Palatability Summary of Oral BIC/LEN FDC at Week 24 Assessed by Questionnaire', 'timeFrame': 'Week 24', 'description': 'Palatability and acceptability assessed by a numeric response between numbers 1-5. Higher scores indicate better palatability and acceptability.'}, {'measure': 'Acceptability and Palatability Summary of Oral BIC/LEN FDC at Week 48 Assessed by Questionnaire', 'timeFrame': 'Week 48', 'description': 'Palatability and acceptability assessed by a numeric response between numbers 1-5. Higher scores indicate better palatability and acceptability.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV-1-infection']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.gileadclinicaltrials.com/study?nctid=NCT06532656', 'label': 'Gilead Clinical Trials Website'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical study is to learn about the safety and tolerability of bictegravir/lenacapavir (BIC/LEN) and to learn how the study drug interacts with the body in virologically suppressed (VS) children and adolescents with human immunodeficiency virus type 1 (HIV-1) on a stable and complex antiretroviral (ARV) regimen. The study will also assess the safe loading dose of LEN and pharmacokinetics (PK) of BIC/LEN.\n\nThe primary objectives of this study are:\n\n* To evaluate the steady-state PK of BIC and LEN and confirm the dose of the LEN loading dose and BIC/LEN FDC in VS children and adolescents with HIV-1.\n* To evaluate the safety and tolerability of BIC/LEN through Week 24 in VS children and adolescents with HIV-1.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Age and body weight at screening:\n\n * Cohort 1: ≥ 12 years to \\< 18 years weighing ≥ 35 kg.\n * Cohort 2: ≥ 6 years to \\< 12 years weighing ≥ 25 kg to \\< 35 kg.\n * Cohort 3: ≥ 2 years to \\< 6 years weighing ≥ 10 kg to \\< 25 kg.\n* On a complex ARV regimen. Complex regimens are any ARV therapy that is not a single-tablet regimen taken once daily (eg, \\> 1 tablet or any other formulation a day).\n* Documented plasma HIV-1 ribonucleic acid (RNA) levels must be \\< 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is \\< 50 copies/mL) in the last 6 months prior to screening (at least 1 measure prior to screening).\n* Plasma HIV-1 RNA levels \\< 50 copies/mL at screening.\n* No documented or suspected resistance to integrase strand transfer inhibitors (mutations T66A/I/K, E92G/Q/V, G118R, F121C/Y, G140R, Y143C/H/R, S147G, Q148H/K/R, N155H/S, or R263K in the integrase gene).\n* The following laboratory parameters at screening:\n\n * Estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2 using the Bedside Schwartz formula.\n * Absolute neutrophil count \\> 0.50 cells/L (\\> 500 cells/mm3).\n * Hemoglobin ≥ 85 g/L (\\> 8.5 g/dL).\n * Platelets ≥ 50 cells/L (≥ 50,000 cells/mm3).\n * Hepatic transaminases (aspartate aminotransferase and alanine aminotransferase)\n\n ≤ 5 x upper limit of normal.\n * Total bilirubin ≤ 23 μmol/L (≤ 1.5 mg/dL) and direct bilirubin ≤ 7 μmol/L (≤ 0.4 mg/dL).\n\nKey Exclusion Criteria:\n\n* CD4 cell count \\< 200 cells/mm\\^3.\n* CD4 percentage \\< 20%.\n* Life expectancy ≤ 1 year.\n* An opportunistic illness indicative of Stage 3 HIV diagnosed within the 30 days prior to screening.\n* Evidence of active pulmonary or extrapulmonary tuberculosis within 3 months prior to screening.\n* Acute hepatitis within 30 days prior to screening.\n* Positive hepatitis C virus (HCV) antibody with detectable HCV RNA (participants positive for HCV antibody will have an HCV RNA test performed).\n* Positive hepatitis B surface antigen (HBsAg) or positive hepatitis B virus (HBV) core antibody (antibody against hepatitis B core antigen \\[anti-HBc\\]) at screening. If a participant is negative for HBsAg and positive for anti-HBc but HBV DNA is undetectable, the participant may be enrolled.\n* A history of or current decompensated liver cirrhosis (eg, ascites, encephalopathy, or variceal bleeding).Current alcohol or substance use judged by the investigator to potentially interfere with the participant's study compliance.\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT06532656', 'briefTitle': 'Study of Bictegravir/Lenacapavir in Children and Adolescents With HIV-1', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'A Phase 2/3, Open-Label Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of Bictegravir/Lenacapavir in Children and Adolescents With HIV-1', 'orgStudyIdInfo': {'id': 'GS-US-621-6463'}, 'secondaryIdInfos': [{'id': '2023-509428-16', 'type': 'OTHER', 'domain': 'European Medicines Agency'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1: Participants Aged ≥ 12 to < 18 years with Weight ≥ 35 kg: BIC/LEN 75/50 mg FDC', 'description': 'Participants will receive a 2-day oral loading dose of LEN (600 mg) on Days 1 and 2 and daily oral BIC/LEN 75/50 mg starting on Day 1 through Week 48.\n\nFollowing Week 48, participants will have an option to continue BIC/LEN in the extension period.', 'interventionNames': ['Drug: Lenacapavir', 'Drug: BIC/LEN FDC']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2: Participants Aged ≥ 6 to < 12 years with Weight ≥ 25 kg to < 35 kg', 'description': 'All participants will receive a 2-day oral loading dose of LEN, and daily oral BIC and LEN dose starting on Day 1 through Week 48. Dose in cohort 2 to be defined.\n\nFollowing Week 48, participants will have an option to continue BIC/LEN in the extension period.', 'interventionNames': ['Drug: Lenacapavir', 'Drug: BIC/LEN FDC']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3: Participants Aged ≥ 2 to < 6 years with Weight ≥ 10 kg to < 25 kg', 'description': 'All participants will receive a 2-day oral loading dose of LEN, and daily oral BIC and LEN dose starting on Day 1 through Week 48. Dose in cohort 3 to be defined.\n\nFollowing Week 48, participants will have an option to continue BIC/LEN in the extension period.', 'interventionNames': ['Drug: Lenacapavir', 'Drug: BIC/LEN FDC']}], 'interventions': [{'name': 'Lenacapavir', 'type': 'DRUG', 'otherNames': ['GS-6207'], 'description': 'Tablets administered orally without regard to food', 'armGroupLabels': ['Cohort 1: Participants Aged ≥ 12 to < 18 years with Weight ≥ 35 kg: BIC/LEN 75/50 mg FDC', 'Cohort 2: Participants Aged ≥ 6 to < 12 years with Weight ≥ 25 kg to < 35 kg', 'Cohort 3: Participants Aged ≥ 2 to < 6 years with Weight ≥ 10 kg to < 25 kg']}, {'name': 'BIC/LEN FDC', 'type': 'DRUG', 'description': 'Tablets administered orally without regard to food', 'armGroupLabels': ['Cohort 1: Participants Aged ≥ 12 to < 18 years with Weight ≥ 35 kg: BIC/LEN 75/50 mg FDC', 'Cohort 2: Participants Aged ≥ 6 to < 12 years with Weight ≥ 25 kg to < 35 kg', 'Cohort 3: Participants Aged ≥ 2 to < 6 years with Weight ≥ 10 kg to < 25 kg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United States', 'facility': "Children's National Hospital", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Grady Ponce de Leon Center', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60614', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': "Ann and Robert H. Lurie Children's Hospital of Chicago", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': 'C1141ACG,', 'city': 'Buenos Aires', 'status': 'RECRUITING', 'country': 'Argentina', 'facility': 'Helios Salud S.A', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '20157', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'facility': 'ASST FBF Sacco Ospedale Sacco', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '00165', 'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'facility': 'IRCCS Ospedale Pediatrico Bambino Gesu, UOS Infezioni Complesse e Perinatali', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '7505', 'city': 'Cape Town', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'South Africa', 'facility': 'FAMCRU Ukwanda School for Rural Health', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '7646', 'city': 'Cape Town', 'status': 'RECRUITING', 'country': 'South Africa', 'facility': 'Be Part Yoluntu', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '3629', 'city': 'Durban', 'status': 'RECRUITING', 'country': 'South Africa', 'facility': 'Durban International Clinical Research Site, Enhancing Care Foundation', 'geoPoint': {'lat': -29.8579, 'lon': 31.0292}}, {'zip': '1862', 'city': 'Johannesburg', 'status': 'RECRUITING', 'country': 'South Africa', 'facility': 'Perinatal HIV Research Unit', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'zip': '2038', 'city': 'Johannesburg', 'status': 'RECRUITING', 'country': 'South Africa', 'facility': 'Wits RHI Shandukani Research Centre CRS', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'zip': '2112', 'city': 'Johannesburg', 'status': 'RECRUITING', 'country': 'South Africa', 'facility': 'Nkanyezi VIDA Research Unit', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'zip': '944', 'city': 'Ka-Majosi', 'status': 'RECRUITING', 'country': 'South Africa', 'facility': 'Khomanani Health Research and Wellness Centre'}, {'zip': '4449', 'city': 'KwaDukuza', 'status': 'RECRUITING', 'country': 'South Africa', 'facility': 'Clinical Research Institute of South Africa (CRISA)', 'geoPoint': {'lat': -29.32816, 'lon': 31.28954}}, {'zip': '0087', 'city': 'Pretoria', 'status': 'RECRUITING', 'country': 'South Africa', 'facility': 'The Aurum Institute: Pretoria Clinical Research Centre', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'zip': '0152', 'city': 'Soshanguve', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'South Africa', 'facility': 'Setshaba Research Centre', 'geoPoint': {'lat': -25.47288, 'lon': 28.09919}}, {'zip': '28007', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital General Universitario Gregorio Marano', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28041', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario 12 De Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28046', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], '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'}}}}