Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-28 @ 12:16 AM
Study NCT ID:
NCT05729568
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-15
First Post:
2023-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Teropavimab and Zinlirvimab in Combination With Capsid Inhibitor Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000730993', 'term': 'lenacapavir'}, {'id': 'D023241', 'term': 'Antiretroviral Therapy, Highly Active'}], 'ancestors': [{'id': 'D004359', 'term': 'Drug Therapy, Combination'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GileadClinicalTrials@gilead.com', 'phone': '1-833-445-3230 (GILEAD-0)', 'title': 'Gilead Clinical Study Information Center', 'organization': 'Gilead Sciences'}, 'certainAgreement': {'otherDetails': 'After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:\n\n* The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or\n* The study has been completed at all study sites for at least 2 years', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All-cause Mortality and Adverse events: Up to Week 26', 'description': 'All-cause mortality: The All Randomized Analysis Set included all participants who were randomized into the study.\n\nAdverse events: The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).', 'eventGroups': [{'id': 'EG000', 'title': 'Randomized Phase Treatment Group 1: LEN + TAB + ZAB', 'description': 'Participants received loading dose of LEN 600 mg tablets, orally, on Day 1 and Day 2. They received LEN 927 mg SC injection along with TAB 2550 mg IV infusion and ZAB 2550 mg IV infusion on Day 1 and Q6M up to Week 52 in the Randomized Phase.\n\nAt Week 52, participants in this group with HIV-1 RNA \\< 50 copies/mL are given the option to participate in the study extension phase. In the study extension phase, participants continued to receive their randomized study drugs every 26 weeks.', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 56, 'otherNumAffected': 40, 'seriousNumAtRisk': 53, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Randomized Phase Treatment Group 3: SBR', 'description': 'Participants in SBR group continued their baseline oral ART up to Week 52. Antiretroviral therapy included drugs like bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir alafenamide, dolutegravir/abacavir lamivudine, and rilpivirine/emtricitabine/tenofovir alafenamide, administered as per standard of care.\n\nAt Week 52, participants in this group with HIV-1 RNA \\< 50 copies/mL and in the absence of confirmed virologic rebound throughout the Randomized Phase of the study are given the option to participate in the Extension Phase to switch from ART to LEN, TAB and ZAB, every 26 weeks at the dose specified for Treatment Group 1.', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 4, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Injection site mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Injection site nodule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}], 'seriousEvents': [{'term': 'Pancreatic carcinoma metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) ≥ 50 Copies/mL at Week 26 as Determined by the United States Food and Drug Administration (US FDA)-Defined Snapshot Algorithm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Phase Treatment Group 1: LEN + TAB+ ZAB', 'description': 'Participants received loading dose of LEN 600 mg tablets, orally, on Day 1 and Day 2. They received LEN 927 mg SC injection along with TAB 2550 mg IV infusion and ZAB 2550 mg IV infusion on Day 1 and Q6M up to Week 52 in the Randomized Phase.\n\nAt Week 52, participants in this group with HIV-1 RNA \\< 50 copies/mL are given the option to participate in the study extension phase. In the study extension phase, participants continued to receive their randomized study drugs every 26 weeks.'}, {'id': 'OG001', 'title': 'Randomized Phase Treatment Group 3: SBR', 'description': 'Participants in SBR group continued their baseline oral ART up to Week 52. Antiretroviral therapy included drugs like bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir alafenamide, dolutegravir/abacavir lamivudine, and rilpivirine/emtricitabine/tenofovir alafenamide, administered as per standard of care.\n\nAt Week 52, participants in this group with HIV-1 RNA \\< 50 copies/mL and in the absence of confirmed virologic rebound throughout the Randomized Phase of the study are given the option to participate in the Extension Phase to switch from oral ART to LEN, TAB and ZAB, every 26 weeks at the dose specified for Treatment Group 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '10.1'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '12.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 26', 'description': "Percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 26 was analyzed using US FDA-defined snapshot algorithm, which defines a participant's virologic outcome and included participants a) who had last available on-treatment HIV-1 RNA ≥ 50 copies/mL in the Week 26 analysis window; b) who did not have on-treatment HIV-1 RNA data in the Week 26 analysis window and i) discontinued study drug prior to or in the Week 26 analysis window due to lack of efficacy, or ii) discontinued study drug prior to or in the Week 26 analysis window due to adverse event (AE) or death and had last available on-treatment HIV-1 RNA ≥ 50 copies/mL, or iii) discontinued study drug prior to or in the Week 26 analysis window due to reasons other than AE, death, or lack of efficacy and had the last available on-treatment HIV-1 RNA ≥ 50 copies/mL.\n\nClopper-Pearson exact method was used to calculate the 95% confidence interval (CI) for the outcome measure of each treatment. Percentages were rounded off.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set were analyzed. The Full Analysis Set included all randomized participants who have received at least one dose of the complete long acting study drug regimen (ie, SC LEN + TAB, ZAB) or continued with their baseline ART regimen.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 52 as Determined by the US FDA-defined Snapshot Algorithm', 'timeFrame': 'Week 52', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 26 as Determined by the US FDA-defined Snapshot Algorithm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Phase Treatment Group 1: LEN + TAB + ZAB', 'description': 'Participants received loading dose of LEN 600 mg tablets, orally, on Day 1 and Day 2. They received LEN 927 mg SC injection along with TAB 2550 mg IV infusion and ZAB 2550 mg IV infusion on Day 1 and Q6M up to Week 52 in the Randomized Phase.\n\nAt Week 52, participants in this group with HIV-1 RNA \\< 50 copies/mL are given the option to participate in the study extension phase. In the study extension phase, participants continued to receive their randomized study drugs every 26 weeks.'}, {'id': 'OG001', 'title': 'Randomized Phase Treatment Group 3: SBR', 'description': 'Participants in SBR group continued their baseline oral ART up to Week 52. Antiretroviral therapy included drugs like bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir alafenamide, dolutegravir/abacavir lamivudine, and rilpivirine/emtricitabine/tenofovir alafenamide, administered as per standard of care.\n\nAt Week 52, participants in this group with HIV-1 RNA \\< 50 copies/mL and in the absence of confirmed virologic rebound throughout the Randomized Phase of the study are given the option to participate in the Extension Phase to switch from oral ART to LEN, TAB and ZAB, every 26 weeks at the dose specified for Treatment Group 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '96.2', 'groupId': 'OG000', 'lowerLimit': '87.0', 'upperLimit': '99.5'}, {'value': '96.3', 'groupId': 'OG001', 'lowerLimit': '81.0', 'upperLimit': '99.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 26', 'description': "Percentage of participants with HIV-1 RNA \\< 50 copies/mL at Week 26 was analyzed using the US FDA-defined snapshot algorithm, which defined a participant's virologic outcome and included participants who had the last available on-treatment HIV-1 RNA \\< 50 copies/mL in the Week 26 analysis window.\n\nThe Clopper-Pearson exact method was used to calculate the 95% CI for the outcome measure of each treatment. Percentages were rounded off.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 52 as Determined by the US FDA-defined Snapshot Algorithm', 'timeFrame': 'Week 52', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Clusters of Differentiation 4 (CD4) + T-cell Counts at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Phase Treatment Group 1: LEN + TAB + ZAB', 'description': 'Participants received loading dose of LEN 600 mg tablets, orally, on Day 1 and Day 2. They received LEN 927 mg SC injection along with TAB 2550 mg IV infusion and ZAB 2550 mg IV infusion on Day 1 and Q6M up to Week 52 in the Randomized Phase.\n\nAt Week 52, participants in this group with HIV-1 RNA \\< 50 copies/mL are given the option to participate in the study extension phase. In the study extension phase, participants continued to receive their randomized study drugs every 26 weeks.'}, {'id': 'OG001', 'title': 'Randomized Phase Treatment Group 3: SBR', 'description': 'Participants in SBR group continued their baseline oral ART up to Week 52. Antiretroviral therapy included drugs like bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir alafenamide, dolutegravir/abacavir lamivudine, and rilpivirine/emtricitabine/tenofovir alafenamide, administered as per standard of care.\n\nAt Week 52, participants in this group with HIV-1 RNA \\< 50 copies/mL and in the absence of confirmed virologic rebound throughout the Randomized Phase of the study are given the option to participate in the Extension Phase to switch from oral ART to LEN, TAB and ZAB, every 26 weeks at the dose specified for Treatment Group 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'spread': '143.4', 'groupId': 'OG000'}, {'value': '74', 'spread': '202.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1436', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in least-squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-56', 'ciLowerLimit': '-132', 'ciUpperLimit': '20', 'estimateComment': 'Difference in least-squares means (Diff in LSM), and its 95% CI were from ANCOVA model of change from baseline CD4 cell count with treatment as fixed effect and baseline CD4 cell count as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 26', 'unitOfMeasure': 'cells/µL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CD4+ T-cell Counts at Week 52', 'timeFrame': 'Baseline, Week 52', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'Up to approximately 6 years', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Trough Concentration at Week 26 for TAB and ZAB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Phase Treatment Group 1: LEN + TAB + ZAB', 'description': 'Participants received loading dose of LEN 600 mg tablets, orally, on Day 1 and Day 2. They received LEN 927 mg SC injection along with TAB 2550 mg IV infusion and ZAB 2550 mg IV infusion on Day 1 and Q6M up to Week 52 in the Randomized Phase.\n\nAt Week 52, participants in this group with HIV-1 RNA \\< 50 copies/mL are given the option to participate in the study extension phase. In the study extension phase, participants continued to receive their randomized study drugs every 26 weeks.'}], 'classes': [{'title': 'TAB', 'categories': [{'measurements': [{'value': '41.8', 'spread': '22.7', 'groupId': 'OG000'}]}]}, {'title': 'ZAB', 'categories': [{'measurements': [{'value': '72.0', 'spread': '39.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 26', 'description': 'Trough concentration is defined as the concentration of the drug in plasma/serum at the end of the dosing interval.', 'unitOfMeasure': 'µg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the TAB PK Analysis Set and ZAB PK Analysis Set with available data were analyzed.\n\nTAB PK Analysis Set included all randomized participants who have received at least 1 dose of study drug, and have at least 1 non-missing TAB concentration value reported by the PK laboratory test.\n\nZAB PK Analysis Set included all randomized participants who have received at least 1 dose of study drug, and have at least 1 non-missing ZAB concentration value reported by the PK laboratory test.'}, {'type': 'SECONDARY', 'title': 'Trough Concentration at Week 26 for LEN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Phase Treatment Group 1: LEN + TAB+ ZAB', 'description': 'Participants received loading dose of LEN 600 mg tablets, orally, on Day 1 and Day 2. They received LEN 927 mg SC injection along with TAB 2550 mg IV infusion and ZAB 2550 mg IV infusion on Day 1 and Q6M up to Week 52 in the Randomized Phase.\n\nAt Week 52, participants in this group with HIV-1 RNA \\< 50 copies/mL are given the option to participate in the study extension phase. In the study extension phase, participants continued to receive their randomized study drugs every 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.2', 'spread': '10.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 26', 'description': 'Trough concentration is defined as the concentration of the drug in plasma/serum at the end of the dosing interval.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the LEN PK Analysis Set with available data were analyzed. LEN PK Analysis Set included all randomized participants who have received at least 1 dose of study drug, and have at least 1 nonmissing LEN concentration value reported by the PK laboratory test.'}, {'type': 'SECONDARY', 'title': 'Trough Concentration at Week 52 for TAB and ZAB', 'timeFrame': 'Week 52', 'description': 'Trough concentration is defined as the concentration of the drug in plasma/serum at the end of the dosing interval.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Trough Concentration at Week 52 for LEN', 'timeFrame': 'Week 52', 'description': 'Trough concentration is defined as the concentration of the drug in plasma/serum at the end of the dosing interval.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetic (PK) Parameter: AUC0-tau for TAB and ZAB', 'timeFrame': 'Up to approximately 6 years', 'description': 'AUC0-tau is defined as the partial area under the concentration versus time curve from time "0" to time "t".', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'PK Parameter: t1/2 for TAB and ZAB', 'timeFrame': 'Up to approximately 6 years', 'description': 't1/2 is defined as the terminal elimination half-life.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'PK Parameter: Cmax for TAB and ZAB', 'timeFrame': 'Up to approximately 6 years', 'description': 'Cmax is defined as the maximum observed concentration of drug.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'PK Parameter: Cmax for LEN', 'timeFrame': 'Up to approximately 6 years', 'description': 'Cmax is defined as the maximum observed concentration of drug.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'PK Parameter: Tmax for TAB, ZAB, and LEN', 'timeFrame': 'Up to approximately 6 years', 'description': 'Tmax is defined as the time (observed time point) of Cmax.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Treatment-emergent Anti-TAB and Anti-ZAB Antibodies', 'timeFrame': 'Up to approximately 6 years', 'description': 'Anti-TAB and anti-ZAB antibodies incidence referred to the percentage of participants who have treatment-emergent anti-TAB and anti-ZAB antibodies among all participants evaluable for anti-drug antibody (ADA) incidence.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Randomized Phase Treatment Group 1: LEN + TAB + ZAB', 'description': 'Participants received loading dose of Lenacapavir (LEN) 600 mg tablets, orally, on Day 1 and Day 2. They received LEN 927 mg subcutaneous (SC) injection along with teropavimab (TAB) 2550 mg intravenous (IV) infusion and zinlirvimab (ZAB) 2550 mg IV infusion on Day 1 and every 6 months (Q6M) or every 26 weeks (Q26W) up to Week 52 in the Randomized Phase.\n\nAt Week 52, participants in this group with HIV-1 RNA \\< 50 copies/mL are given the option to participate in the study extension phase. In the study extension phase, participants continued to receive their randomized study drugs every 26 weeks.'}, {'id': 'FG001', 'title': 'Randomized Phase Treatment Group 3: SBR', 'description': 'Participants in Stay on Baseline Regimen (SBR) group continued their baseline oral antiretroviral therapy (ART) up to Week 52. Antiretroviral therapy included drugs like bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir alafenamide, dolutegravir/abacavir lamivudine, and rilpivirine/emtricitabine/tenofovir alafenamide, administered as per standard of care.\n\nAt Week 52, participants in this group with HIV-1 RNA \\< 50 copies/mL and in the absence of confirmed virologic rebound throughout the Randomized Phase of the study are given the option to participate in the Extension Phase to switch from ART to LEN, TAB and ZAB, every 26 weeks at the dose specified for Treatment Group 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '27'}]}], 'dropWithdraws': [{'type': 'Still on Study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'Randomized but Never Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': "Investigator's Discretion", 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '241 participants were screened. The study planned to enroll participants in Treatment Groups 1, 2 and 3. However, per review of the programmatic data overall and from study GS-US-536-5816 (NCT04811040), Treatment Group 2 was removed prior to dosing of all groups in the study and did not enroll any participants. Therefore, data is reported only for Treatment Groups 1 and 3.', 'preAssignmentDetails': 'Participants were enrolled at study sites in the United States, Puerto Rico, Australia, and Canada.\n\nData submitted represent primary analysis performed on data collected by the Primary Analysis Completion Date (02-July-2024). Complete data will be submitted within 1 year of actual study completion date.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Randomized Phase Treatment Group 1: LEN + TAB + ZAB', 'description': 'Participants received loading dose of LEN 600 mg tablets, orally, on Day 1 and Day 2. They received LEN 927 mg SC injection along with TAB 2550 mg IV infusion and ZAB 2550 mg IV infusion on Day 1 and Q6M up to Week 52 in the Randomized Phase.\n\nAt Week 52, participants in this group with HIV-1 RNA \\< 50 copies/mL are given the option to participate in the study extension phase. In the study extension phase, participants continued to receive their randomized study drugs every 26 weeks.'}, {'id': 'BG001', 'title': 'Randomized Phase Treatment Group 3: SBR', 'description': 'Participants in SBR group continued their baseline oral ART up to Week 52. Antiretroviral therapy included drugs like bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir alafenamide, dolutegravir/abacavir lamivudine, and rilpivirine/emtricitabine/tenofovir alafenamide, administered as per standard of care.\n\nAt Week 52, participants in this group with HIV-1 RNA \\< 50 copies/mL and in the absence of confirmed virologic rebound throughout the Randomized Phase of the study are given the option to participate in the Extension Phase to switch from ART to LEN, TAB and ZAB, every 26 weeks at the dose specified for Treatment Group 1.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44', 'spread': '13.7', 'groupId': 'BG000'}, {'value': '53', 'spread': '9.6', 'groupId': 'BG001'}, {'value': '47', 'spread': '13.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Puerto Rico', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Clusters of Differentiation 4 (CD4)+ T-cell Counts', 'classes': [{'categories': [{'measurements': [{'value': '740', 'spread': '239.3', 'groupId': 'BG000'}, {'value': '768', 'spread': '260.0', 'groupId': 'BG001'}, {'value': '749', 'spread': '245.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cells/µL', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, teropavimab, zinlirvimab, or continued with their baseline ART regimen).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-05-13', 'size': 2999671, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-06-23T12:01', 'hasProtocol': True}, {'date': '2024-08-12', 'size': 1944623, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-05-07T10:53', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-26', 'studyFirstSubmitDate': '2023-02-06', 'resultsFirstSubmitDate': '2025-06-26', 'studyFirstSubmitQcDate': '2023-02-06', 'lastUpdatePostDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-26', 'studyFirstPostDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) ≥ 50 Copies/mL at Week 26 as Determined by the United States Food and Drug Administration (US FDA)-Defined Snapshot Algorithm', 'timeFrame': 'Week 26', 'description': "Percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 26 was analyzed using US FDA-defined snapshot algorithm, which defines a participant's virologic outcome and included participants a) who had last available on-treatment HIV-1 RNA ≥ 50 copies/mL in the Week 26 analysis window; b) who did not have on-treatment HIV-1 RNA data in the Week 26 analysis window and i) discontinued study drug prior to or in the Week 26 analysis window due to lack of efficacy, or ii) discontinued study drug prior to or in the Week 26 analysis window due to adverse event (AE) or death and had last available on-treatment HIV-1 RNA ≥ 50 copies/mL, or iii) discontinued study drug prior to or in the Week 26 analysis window due to reasons other than AE, death, or lack of efficacy and had the last available on-treatment HIV-1 RNA ≥ 50 copies/mL.\n\nClopper-Pearson exact method was used to calculate the 95% confidence interval (CI) for the outcome measure of each treatment. Percentages were rounded off."}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 52 as Determined by the US FDA-defined Snapshot Algorithm', 'timeFrame': 'Week 52'}, {'measure': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 26 as Determined by the US FDA-defined Snapshot Algorithm', 'timeFrame': 'Week 26', 'description': "Percentage of participants with HIV-1 RNA \\< 50 copies/mL at Week 26 was analyzed using the US FDA-defined snapshot algorithm, which defined a participant's virologic outcome and included participants who had the last available on-treatment HIV-1 RNA \\< 50 copies/mL in the Week 26 analysis window.\n\nThe Clopper-Pearson exact method was used to calculate the 95% CI for the outcome measure of each treatment. Percentages were rounded off."}, {'measure': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 52 as Determined by the US FDA-defined Snapshot Algorithm', 'timeFrame': 'Week 52'}, {'measure': 'Change From Baseline in Clusters of Differentiation 4 (CD4) + T-cell Counts at Week 26', 'timeFrame': 'Baseline, Week 26'}, {'measure': 'Change From Baseline in CD4+ T-cell Counts at Week 52', 'timeFrame': 'Baseline, Week 52'}, {'measure': 'Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'Up to approximately 6 years'}, {'measure': 'Trough Concentration at Week 26 for TAB and ZAB', 'timeFrame': 'Week 26', 'description': 'Trough concentration is defined as the concentration of the drug in plasma/serum at the end of the dosing interval.'}, {'measure': 'Trough Concentration at Week 26 for LEN', 'timeFrame': 'Week 26', 'description': 'Trough concentration is defined as the concentration of the drug in plasma/serum at the end of the dosing interval.'}, {'measure': 'Trough Concentration at Week 52 for TAB and ZAB', 'timeFrame': 'Week 52', 'description': 'Trough concentration is defined as the concentration of the drug in plasma/serum at the end of the dosing interval.'}, {'measure': 'Trough Concentration at Week 52 for LEN', 'timeFrame': 'Week 52', 'description': 'Trough concentration is defined as the concentration of the drug in plasma/serum at the end of the dosing interval.'}, {'measure': 'Pharmacokinetic (PK) Parameter: AUC0-tau for TAB and ZAB', 'timeFrame': 'Up to approximately 6 years', 'description': 'AUC0-tau is defined as the partial area under the concentration versus time curve from time "0" to time "t".'}, {'measure': 'PK Parameter: t1/2 for TAB and ZAB', 'timeFrame': 'Up to approximately 6 years', 'description': 't1/2 is defined as the terminal elimination half-life.'}, {'measure': 'PK Parameter: Cmax for TAB and ZAB', 'timeFrame': 'Up to approximately 6 years', 'description': 'Cmax is defined as the maximum observed concentration of drug.'}, {'measure': 'PK Parameter: Cmax for LEN', 'timeFrame': 'Up to approximately 6 years', 'description': 'Cmax is defined as the maximum observed concentration of drug.'}, {'measure': 'PK Parameter: Tmax for TAB, ZAB, and LEN', 'timeFrame': 'Up to approximately 6 years', 'description': 'Tmax is defined as the time (observed time point) of Cmax.'}, {'measure': 'Percentage of Participants With Treatment-emergent Anti-TAB and Anti-ZAB Antibodies', 'timeFrame': 'Up to approximately 6 years', 'description': 'Anti-TAB and anti-ZAB antibodies incidence referred to the percentage of participants who have treatment-emergent anti-TAB and anti-ZAB antibodies among all participants evaluable for anti-drug antibody (ADA) incidence.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV Infection']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Mponponsuo K, McMahon JH, Gorgos L, Morales-Ramirez J, Workowski K, Brunetta J, Ogbuagu O, Collins SE, VanderVeen LA, Huang H, Baeten JM, Eron JJ. Efficacy and Safety of Lenacapavir, Teropavimab, and Zinlirvimab: Phase II Week 26 Primary Outcome [Oral 07]. Conference on Retroviruses and Opportunistic Infections (CROI); 2025 9-12 March, San Francisco, CA.'}], 'seeAlsoLinks': [{'url': 'https://www.gileadclinicaltrials.com/study/?id=GS-US-536-5939', 'label': 'Gilead Clinical Trials Website'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to test the effectiveness, safety, and tolerability of the combination of broadly neutralizing antibodies (bNAbs) (teropavimab (TAB; GS-5423) and zinlirvimab (ZAB; GS-2872)) with lenacapavir (LEN) in virologically suppressed adults with HIV-1 infection.\n\nThe purpose of this study is to evaluate the efficacy of switching to a regimen of LEN, TAB and ZAB, versus continuing on baseline oral antiretroviral therapy (ART) as determined by the proportion of participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) ≥ 50 copies/mL at Week 26.', 'detailedDescription': 'Participants will be randomized in Treatment Groups 1 and 2 to receive LEN, TAB, and ZAB, with differing doses of TAB and ZAB between the 2 groups and in Treatment Group 3 to continue their baseline oral ART for 52 weeks. Eligible participants in Treatment Groups 1 through 3 will have the option of participating in the study extension phase to receive LEN, TAB and ZAB after completing study follow-up through Week 52.\n\nTreatment Group 2 was removed prior to dosing of all groups during Protocol Amendment 2.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* On stable oral antiretroviral therapy (ART) consisting of no more than 2 drug classes (with the exception of pharmacologic boosters cobicistat or ritonavir) for ≥ 1 year prior to screening visit 2. A change in ART regimen ≥ 28 days prior to screening visit 2 for reasons other than virologic failure (VF) (eg, tolerability, simplification, drug-drug interaction profile) is allowed.\n* No clinically significant documented historical resistance to the current ART regimen with the exception of isolated nucleoside reverse transcriptase inhibitor mutations including M184V or ≤ 2 thymidine analog mutations (TAMs: M41L, D67N, K70R, L210W, T215Y, and/or K219Q).\n* Plasma human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \\< 50 copies/mL at screening visit 2.\n* Documented plasma HIV-1 RNA \\< 50 copies/mL for ≥ 12 months preceding screening visit 2 (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL). Virologic elevations of ≥ 50 copies/mL (transient detectable viremia or "blips") prior to screening are acceptable.\n* Proviral phenotypic sensitivity to both teropavimab and zinlirvimab at screening or from protocol GS-US-536-5816 within 24 months prior to screening.\n* Screening clusters of differentiation 4 (CD4)+ T-cell count ≥ 200 cells/μL at screening visit 2.\n\nKey Exclusion Criteria:\n\n* Comorbid condition requiring ongoing immunosuppression.\n* Evidence of hepatitis C virus (HCV) infection (prior infection cleared spontaneously or with treatment is acceptable)\n* Evidence of current hepatitis B virus (HBV) infection regardless of HBV surface antigen status, at the screening visit 2.\n* History of opportunistic infection or illness indicative of Stage 3 HIV disease.\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT05729568', 'briefTitle': 'A Study of Teropavimab and Zinlirvimab in Combination With Capsid Inhibitor Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'A Phase 2 Randomized, Open-label Study to Evaluate the Safety and Efficacy of Broadly Neutralizing Antibodies (bNAbs) GS-5423 and GS-2872 in Combination With the Capsid Inhibitor Lenacapavir as Long-Acting Treatment Dosed Every 6 Months in Virologically Suppressed Adults With HIV-1 Infection', 'orgStudyIdInfo': {'id': 'GS-US-536-5939'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Randomized Phase Treatment Group 1: LEN + TAB + ZAB', 'description': 'Participants will receive loading dose of lenacapavir (LEN) 600 mg tablets, orally, on Day 1 and Day 2. They will receive LEN 927 mg subcutaneous (SC) injection along with teropavimab (TAB) 2550 mg intravenous (IV) infusion and zinlirvimab (ZAB) 2550 mg IV infusion on Day 1 and every 6 months (Q6M) up to Week 52 in the Randomized Phase.', 'interventionNames': ['Drug: Teropavimab', 'Drug: Zinlirvimab', 'Drug: Lenacapavir Tablet', 'Drug: Lenacapavir Injection']}, {'type': 'EXPERIMENTAL', 'label': 'Randomized Phase Treatment Group 3: SBR', 'description': 'Participants in Stay on Baseline Regimen (SBR) group will continue their baseline oral antiretroviral therapy (ART) up to Week 52. ART included drugs like bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir alafenamide, dolutegravir/abacavir lamivudine, and rilpivirine/emtricitabine/tenofovir alafenamide, administered as per standard of care.', 'interventionNames': ['Drug: Antiretroviral Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Extension Phase: Treatment Group 1: LEN + TAB + ZAB', 'description': 'At Week 52, participants in this group with HIV-1 RNA \\< 50 copies/mL will be given the option to participate in the study extension phase. In the study extension phase, participants will continue to receive their randomized study drugs every 26 weeks.', 'interventionNames': ['Drug: Teropavimab', 'Drug: Zinlirvimab', 'Drug: Lenacapavir Injection']}, {'type': 'EXPERIMENTAL', 'label': 'Extension Phase Treatment Group 3: SBR', 'description': 'At Week 52, participants in this group with HIV-1 RNA \\< 50 copies/mL and in the absence of confirmed virologic rebound throughout the Randomized Phase of the study will be given the option to participate in the Extension Phase to switch from oral ART to LEN, TAB and ZAB, every 26 weeks at the dose specified for Treatment Group 1.', 'interventionNames': ['Drug: Teropavimab', 'Drug: Zinlirvimab', 'Drug: Lenacapavir Tablet', 'Drug: Lenacapavir Injection']}], 'interventions': [{'name': 'Teropavimab', 'type': 'DRUG', 'otherNames': ['GS-5423'], 'description': 'Administered intravenously', 'armGroupLabels': ['Extension Phase Treatment Group 3: SBR', 'Extension Phase: Treatment Group 1: LEN + TAB + ZAB', 'Randomized Phase Treatment Group 1: LEN + TAB + ZAB']}, {'name': 'Zinlirvimab', 'type': 'DRUG', 'otherNames': ['GS-2872'], 'description': 'Administered intravenously', 'armGroupLabels': ['Extension Phase Treatment Group 3: SBR', 'Extension Phase: Treatment Group 1: LEN + TAB + ZAB', 'Randomized Phase Treatment Group 1: LEN + TAB + ZAB']}, {'name': 'Lenacapavir Tablet', 'type': 'DRUG', 'otherNames': ['GS-6207'], 'description': 'Administered orally', 'armGroupLabels': ['Extension Phase Treatment Group 3: SBR', 'Randomized Phase Treatment Group 1: LEN + TAB + ZAB']}, {'name': 'Lenacapavir Injection', 'type': 'DRUG', 'otherNames': ['GS-6207', 'Sunlenca®'], 'description': 'Administered subcutaneously', 'armGroupLabels': ['Extension Phase Treatment Group 3: SBR', 'Extension Phase: Treatment Group 1: LEN + TAB + ZAB', 'Randomized Phase Treatment Group 1: LEN + TAB + ZAB']}, {'name': 'Antiretroviral Therapy', 'type': 'DRUG', 'description': 'Antiretroviral therapy, administered orally may include regimens such as: bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir alafenamide, dolutegravir/abacavir lamivudine, and rilpivirine/emtricitabine/tenofovir alafenamide.', 'armGroupLabels': ['Randomized Phase Treatment Group 3: SBR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90036', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Ruane Clinical Research Group, Inc.', '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': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'UC San Diego (UCSD) AntiViral Research Center (AVRC)', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94102', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Optimus Medical Group', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Clinical and Translational Research Center', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University; School of Medicine; AIDS Program', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'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 Care', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '34982', 'city': 'Ft. Pierce', 'state': 'Florida', 'country': 'United States', 'facility': 'Midway Immunology and Research Center', 'geoPoint': {'lat': 27.44671, 'lon': -80.32561}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Orlando Immunology Center', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33407', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Triple O Research Institute, P.A.', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Hospital Midtown Infectious Disease Clinic', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30033', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'Infectious Disease Specialists of Atlanta', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '63139', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Southhampton Healthcare, Inc', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '87109', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'AXCES Research Group, LLC', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '27514', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Health Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27401', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Regional Center for Infectious Disease Research', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '27858', 'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'The Brody School of Medicine at East Carolina University', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}, {'zip': '28078', 'city': 'Huntersville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Rosedale Health and Wellness', 'geoPoint': {'lat': 35.41069, 'lon': -80.84285}}, {'zip': '29203', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Prisma Health - Clinical Research Unit', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'zip': '38105', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': "St Jude Children's Research Hospital", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Central Texas Clinical Research', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75208', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'AIDS Arms, Inc. DBA Prism Health North Texas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '79902', 'city': 'El Paso', 'state': 'Texas', 'country': 'United States', 'facility': 'AXCES Research Group, LLC', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}, {'zip': '77098', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The Crofoot Research Center, INC', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '22003', 'city': 'Annandale', 'state': 'Virginia', 'country': 'United States', 'facility': 'Clinical Alliance for Research & Education, Infectious Diseases LLC (CARE-ID)', 'geoPoint': {'lat': 38.83039, 'lon': -77.19637}}, {'zip': '2010', 'city': 'Darlinghurst', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'East Sydney Doctors', 'geoPoint': {'lat': -33.87939, 'lon': 151.21925}}, {'zip': '2010 NSW', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Holdsworth House Medical Practice', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Alfred Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': 'M5G 1K2', 'city': 'Toronto', 'country': 'Canada', 'facility': 'Maple Leaf Research/Maple Leaf Medical Clinic', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '909', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Clinical Research Puerto Rico', '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'}}}}