Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-03-05 @ 9:54 PM
Study NCT ID:
NCT06544733
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-25
First Post:
2024-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Oral Weekly GS-1720 and GS-4182 Versus Biktarvy in People With HIV-1 Who Are Virologically Suppressed
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada']}, 'interventionBrowseModule': {'meshes': [{'id': 'C000654125', 'term': 'bictegravir, emtricitabine, tenofovir alafenamide, drug combination'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Phase 2 (Treatment Group 1, Treatment Group 2, and Extension Phase) arms and Phase 3 Extension Phase arm are open-label; Phase 3 Treatment Group 1 and Phase 3 Treatment Group 2 arms are blinded.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 675}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2029-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-22', 'studyFirstSubmitDate': '2024-08-05', 'studyFirstSubmitQcDate': '2024-08-05', 'lastUpdatePostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase 2: Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 24 as Determined by the United States (US) Food and Drug Administration (FDA)-defined Snapshot Algorithm', 'timeFrame': 'Week 24'}, {'measure': 'Phase 3: Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm', 'timeFrame': 'Week 48'}], 'secondaryOutcomes': [{'measure': 'Phase 2: Proportion of Participants With HIV-1 RNA ≥ 50 copies/mL at Week 12 as Determined by the US FDA-defined Snapshot Algorithm', 'timeFrame': 'Week 12'}, {'measure': 'Phase 2: Proportion of Participants With HIV-1 RNA ≥ 50 copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm', 'timeFrame': 'Week 48'}, {'measure': 'Phase 2: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 as Determined by the US FDA-defined Snapshot Algorithm', 'timeFrame': 'Week 12'}, {'measure': 'Phase 2: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Determined by the US FDA-defined Snapshot Algorithm', 'timeFrame': 'Week 24'}, {'measure': 'Phase 2: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm', 'timeFrame': 'Week 48'}, {'measure': 'Phase 2: Change From Baseline in Clusters of Differentiation 4 (CD4+) T-cell Count at Week 12', 'timeFrame': 'Baseline, Week 12'}, {'measure': 'Phase 2: Change From Baseline in CD4+ T-cell Count at Week 24', 'timeFrame': 'Baseline, Week 24'}, {'measure': 'Phase 2: Change From Baseline in CD4+ T-cell Count at Week 48', 'timeFrame': 'Baseline, Week 48'}, {'measure': 'Phase 2: Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) Through Week 12', 'timeFrame': 'First dose date up to Week 12'}, {'measure': 'Phase 2: Percentage of Participants Experiencing TEAEs Through Week 24', 'timeFrame': 'First dose date up to Week 24'}, {'measure': 'Phase 2: Percentage of Participants Experiencing TEAEs Through Week 48', 'timeFrame': 'First dose date up to Week 48'}, {'measure': 'Phase 2: Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities Through Week 12', 'timeFrame': 'First dose date up to Week 12'}, {'measure': 'Phase 2: Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities Through Week 24', 'timeFrame': 'First dose date up to Week 24'}, {'measure': 'Phase 2: Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities Through Week 48', 'timeFrame': 'First dose date up to Week 48'}, {'measure': 'Phase 2: Pharmacokinetic (PK) Parameter: Cmax of GS-1720 and Lenacapavir (LEN)', 'timeFrame': 'Day 1 up to Week 48', 'description': 'Cmax is defined as the maximum observed concentration of drug.'}, {'measure': 'Phase 2: PK Parameter: Tmax of GS-1720 and LEN', 'timeFrame': 'Day 1 up to Week 48', 'description': 'Tmax is defined as the time (observed time point) of Cmax.'}, {'measure': 'Phase 2: PK Parameter: Ctau of GS-1720 and LEN', 'timeFrame': 'Day 1 up to Week 48', 'description': 'Ctau is defined as the observed drug concentration at the end of the dosing interval.'}, {'measure': 'Phase 2: PK Parameter: AUCtau of GS-1720 and LEN', 'timeFrame': 'Day 1 up to Week 48', 'description': 'AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).'}, {'measure': 'Phase 3: Proportion of Participants With HIV-1 RNA ≥ 50 copies/mL at Week 96 as Determined by the US FDA-defined Snapshot Algorithm', 'timeFrame': 'Week 96'}, {'measure': 'Phase 3: Proportion of Participants With HIV-1 RNA < 50 copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm', 'timeFrame': 'Week 48'}, {'measure': 'Phase 3: Proportion of Participants With HIV-1 RNA < 50 copies/mL at Week 96 as Determined by the US FDA-defined Snapshot Algorithm', 'timeFrame': 'Week 96'}, {'measure': 'Phase 3: Change From Baseline in CD4+ T-cell Count at Week 48', 'timeFrame': 'Baseline, Week 48'}, {'measure': 'Phase 3: Change From Baseline in CD4+ T-cell Count at Week 96', 'timeFrame': 'Baseline, Week 96'}, {'measure': 'Phase 3: Percentage of Participants Experiencing TEAEs Through Week 48', 'timeFrame': 'First dose date up to Week 48'}, {'measure': 'Phase 3: Proportion of Participants Experiencing TEAEs Through Week 96', 'timeFrame': 'First dose date up to Week 96'}, {'measure': 'Phase 3: Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities Through Week 48', 'timeFrame': 'First dose date up to Week 48'}, {'measure': 'Phase 3: Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities Through Week 96', 'timeFrame': 'First dose date up to Week 96'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV-1-Infection']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.gileadclinicaltrials.com/study?nctid=NCT06544733', 'label': 'Gilead Clinical Trials Website'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical study is to learn more about the experimental drugs GS-1720 and GS-4182; to compare the combination of GS-1720 and GS-4182 with the current standard-of-care treatment bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF, BVY), to see if the combination of GS-1720 and GS-4182 is safe and if it works for treating human immunodeficiency virus type 1 (HIV-1) infection.\n\nThis study has two phases: Phase 2 and Phase 3.\n\nThe primary objectives of this study are:\n\nPhase 2: To evaluate the efficacy of switching to oral weekly GS-1720 in combination with GS-4182 versus continuing BVY in virologically suppressed people with HIV-1 (PWH) at Week 24.\n\nPhase 3: To evaluate the efficacy of switching to oral weekly GS-1720/GS-4182 Fixed-dose combination (FDC) tablet regimen versus continuing BVY in virologically suppressed PWH at Week 48.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Documented plasma HIV-1 RNA \\< 50 copies/mL for ≥ 24 weeks before and at screening.\n* Receiving BVY for ≥ 24 weeks prior to screening.\n\nKey Exclusion Criteria:\n\n* Prior use of, or exposure to LEN, GS-1720, or GS-4182.\n* History of virologic failure while on an integrase strand-transfer inhibitor (INSTI)-based regimen.\n* Documented integrase strand-transfer inhibitor (INSTI) resistance, specifically, resistance-associated mutations (RAMs) E92G/Q, G118R, F121Y, Y143C/H/R, S147G, Q148H/K/R, N155H/S, or R263K in the integrase gene.\n* Prior use of any long-acting (LA) parenteral antiretrovirals (ARV) such as monoclonal antibodies (mAbs) or broadly neutralizing antibodies (bNAbs) targeting HIV-1, injectable cabotegravir (including oral cabotegravir lead-in), or injectable rilpivirine.\n* Any of the following laboratory values at screening:\n\n * Clusters of differentiation 4 (CD4) cell count \\< 200 cells/mm\\^3 at screening\n * Glomerular filtration rate \\< 60 mL/min according to the Modification of Diet in Renal Disease formula\n * Hepatic transaminases (aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\> 1.5 × upper limit of normal (ULN)\n * Direct bilirubin \\> 1.5 × ULN\n * Platelets count \\< 50,000 cells/mm\\^3\n * Hemoglobin \\< 8.0 g/dL\n* Active or occult hepatitis B virus (HBV) infection.\n* Active hepatitis C virus (HCV).\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT06544733', 'acronym': 'WONDERS1', 'briefTitle': 'Study of Oral Weekly GS-1720 and GS-4182 Versus Biktarvy in People With HIV-1 Who Are Virologically Suppressed', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'An Operationally Seamless Phase 2/3, Randomized, Active-Controlled Study Evaluating the Safety and Efficacy of an Oral Weekly Regimen of GS-1720 in Combination With GS-4182 Versus Biktarvy in Virologically Suppressed People With HIV-1', 'orgStudyIdInfo': {'id': 'GS-US-695-6509'}, 'secondaryIdInfos': [{'id': '2024-511054-50', 'type': 'OTHER', 'domain': 'European Medicines Agency'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase 2: GS-1720 + GS-4182 (Treatment Group 1)', 'description': 'Participants who have been virologically suppressed on bictegravir/emtricitabine/tenofovir alafenamide (BVY) will switch to GS-1720 (650 mg tablet) and GS-4182 (300 mg tablet) coadministered. Participants will receive a 1-day loading dose of GS-1720 (1300 mg) and GS-4182 (600 mg) on Day 1. Thereafter, participants will take weekly doses of single agent GS-1720 (650 mg) and GS-4182 (300 mg) coadministered for at least 48 weeks.', 'interventionNames': ['Drug: GS-1720', 'Drug: GS-4182']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Phase 2: Bictegravir/emtricitabine/tenofovir alafenamide (BVY) (Treatment Group 2)', 'description': 'Participants who have been virologically suppressed on bictegravir/emtricitabine/tenofovir alafenamide (BVY) will continue receiving BVY daily for at least 48 weeks.', 'interventionNames': ['Drug: Bictegravir/emtricitabine/tenofovir alafenamide']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2 Extension Phase: GS-1720/GS-4182 Fixed-dose Combination (FDC)', 'description': 'At the end of the randomized treatment, Phase 2 participants will be given the option to participate in the Extension Phase. Phase 2 Treatment Group 1 will switch to GS-1720/GS-4182 FDC weekly. Phase 2 Treatment Group 2 will receive a loading dose of GS-1720/GS-4182 FDC on Extension Phase Day 1 then, GS-1720/GS-4182 FDC weekly. Participants who choose to enter the Extension Phase will receive GS-1720/GS-4182 FDC tablets until the product becomes available or until Gilead Sciences elects to discontinue the study, whichever occurs first.', 'interventionNames': ['Drug: GS-1720/GS-4182 FDC']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 3: GS-1720/GS-4182 FDC + Placebo to Match (PTM) BVY (Treatment Group 1)', 'description': 'Participants who have been virologically suppressed on BVY will switch from BVY to GS-1720/GS-4182 FDC tablets weekly + placebo-to-match (PTM) BVY once daily. In addition, participants will receive a 1-day loading dose regimen of GS-1720/GS-4182 FDC on Day 1.\n\nParticipants will receive treatment for at least 96 weeks.', 'interventionNames': ['Drug: Placebo to Match BVY', 'Drug: GS-1720/GS-4182 FDC']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Phase 3: BVY Placebo to Match GS-1720/GS-4182 FDC + BVY (Treatment Group 2)', 'description': 'Participants who have been virologically suppressed on BVY will continue receiving oral BVY daily. In addition, participants will receive a 1-day loading dose of PTM GS-1720/GS-4182 on Day 1 and weekly PTM thereafter. Participants will receive treatment for at least 96 weeks.', 'interventionNames': ['Drug: Bictegravir/emtricitabine/tenofovir alafenamide', 'Drug: Placebo to Match GS1720/GS-4182 FDC']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 3 Extension Phase: GS-1720/GS-4182 Fixed-dose Combination (FDC)', 'description': 'After the end of blinded treatment, Phase 3 participants will be given the option to participate in the Extension Phase. Phase 3 Treatment Group 1 will switch to GS-1720/GS-4182 FDC weekly. Phase 3 Treatment Group 2 will receive a 1-day loading dose of GS-1720/GS-4182 FDC on Extension Phase Day 1, then GS-1720/GS-4182 FDC weekly. Participants who choose to enter the Extension Phase will receive GS-1720/GS-4182 FDC tablets until the product becomes available or until Gilead Sciences elects to discontinue the study, whichever occurs first.', 'interventionNames': ['Drug: GS-1720/GS-4182 FDC']}], 'interventions': [{'name': 'GS-1720', 'type': 'DRUG', 'description': 'Tablets administered orally without regard to food', 'armGroupLabels': ['Phase 2: GS-1720 + GS-4182 (Treatment Group 1)']}, {'name': 'GS-4182', 'type': 'DRUG', 'description': 'Tablets administered orally without regard to food', 'armGroupLabels': ['Phase 2: GS-1720 + GS-4182 (Treatment Group 1)']}, {'name': 'Placebo to Match BVY', 'type': 'DRUG', 'description': 'Tablets administered orally without regard to food', 'armGroupLabels': ['Phase 3: GS-1720/GS-4182 FDC + Placebo to Match (PTM) BVY (Treatment Group 1)']}, {'name': 'Bictegravir/emtricitabine/tenofovir alafenamide', 'type': 'DRUG', 'otherNames': ['Biktarvy®'], 'description': 'Tablets administered orally without regard to food', 'armGroupLabels': ['Phase 2: Bictegravir/emtricitabine/tenofovir alafenamide (BVY) (Treatment Group 2)', 'Phase 3: BVY Placebo to Match GS-1720/GS-4182 FDC + BVY (Treatment Group 2)']}, {'name': 'GS-1720/GS-4182 FDC', 'type': 'DRUG', 'description': 'Tablets administered orally without regard to food', 'armGroupLabels': ['Phase 2 Extension Phase: GS-1720/GS-4182 Fixed-dose Combination (FDC)', 'Phase 3 Extension Phase: GS-1720/GS-4182 Fixed-dose Combination (FDC)', 'Phase 3: GS-1720/GS-4182 FDC + Placebo to Match (PTM) BVY (Treatment Group 1)']}, {'name': 'Placebo to Match GS1720/GS-4182 FDC', 'type': 'DRUG', 'description': 'Tablets administered orally without regard to food', 'armGroupLabels': ['Phase 3: BVY Placebo to Match GS-1720/GS-4182 FDC + BVY (Treatment Group 2)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'UAB 1917 Research Clinic', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Oaks Medical Group', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '90036', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Ruane Clinical Research Group', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90069', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Mills Clinical Research', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92262', 'city': 'Palm Springs', 'state': 'California', 'country': 'United States', 'facility': 'BIOS Clinical Research', 'geoPoint': {'lat': 33.8303, 'lon': -116.54529}}, {'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Division of HIV, Infectious Diseases & Global Medicine', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University Medical Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32720', 'city': 'DeLand', 'state': 'Florida', 'country': 'United States', 'facility': 'Midland Florida Clinical Research Center, LLC', 'geoPoint': {'lat': 29.02832, 'lon': -81.30312}}, {'zip': '33316', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'CAN Community Health', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '34982', 'city': 'Ft. 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'facility': 'HOPE Clinical Research', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'zip': '00935', 'city': 'San Juan', 'state': 'PR', 'country': 'Puerto Rico', 'facility': 'Proyecto ACTC', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'overallOfficials': [{'name': 'Gilead Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gilead Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}