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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-512505-66 | Other Identifier | European Medicines Agency |
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Sponsor decision to terminate study.
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The goal of this clinical study is to learn more about the experimental drugs lepetegravir (formerly GS-1720) (an oral, long-acting integrase strand transfer inhibitor (INSTI)) and lenacapavir pacfosacil (formerly GS-4182) (a prodrug of Lenacapavir (LEN)); to compare the combination of lepetegravir and lenacapavir pacfosacil with the current standard-of-care treatment bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (Biktarvy), to see if the combination of lepetegravir and lenacapavir pacfosacil is safe and if it works for treating human immunodeficiency virus type 1 (HIV-1) infection in treatment-naive people with HIV-1 (PWH).
This study has two phases: Phase 2 and Phase 3.
The primary objectives of this study are:
Phase 2: To evaluate the efficacy of oral weekly lepetegravir coadministered with lenacapavir pacfosacil versus continuing Biktarvy (BVY) in treatment-naive PWH at Week 24.
Phase 3: To evaluate the efficacy of oral weekly lepetegravir/lenacapavir pacfosacil fixed-dose combination (FDC) tablet regimen versus continuing BVY in treatment-naive PWH at Week 48.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 2: Lepetegravir + Lenacapavir Pacfosacil (Treatment Group 1) | Experimental | Participants will receive a 1-day loading dose of lepetegravir (1300 mg) and lenacapavir pacfosacil (600 mg) on Day 1.Thereafter, participants will take weekly doses of single agent lepetegravir (650 mg) and lenacapavir pacfosacil (300 mg) coadministered for at least 48 weeks. |
|
| Phase 2: B/F/TAF (Treatment Group 2) | Active Comparator | Participants will receive B/F/TAF (50/200/25 mg) daily for at least 48 weeks. |
|
| Phase 2 Extension Phase: Lepetegravir/Lenacapavir Pacfosacil Fixed-dose Combination (FDC) | Experimental | 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 lepetegravir/lenacapavir pacfosacil FDC (650/300 mg) weekly. Phase 2 Treatment Group 2 will receive a loading dose of lepetegravir/lenacapavir pacfosacil FDC (1300 mg/600 mg) on Extension Phase Day 1, then lepetegravir/lenacapavir pacfosacil FDC (650/300 mg) weekly. Participants who choose to enter the Extension Phase will receive lepetegravir/lenacapavir pacfosacil FDC tablets until the product becomes available or until Gilead Sciences elects to discontinue the study, whichever occurs first. |
|
| Phase 3: Lepetegravir/Lenacapavir Pacfosacil FDC + Placebo to Match B/F/TAF (Treatment Group 1) | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lepetegravir | Drug | Tablets administered orally without regard to food |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Week 24 | |
| Phase 3: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm | Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 2: Proportion of Participants With HIV-1 RNA < 50 copies/mL at Week 12 as Determined by the US FDA-defined Snapshot Algorithm | Week 12 | |
| Phase 2: Proportion of Participants With HIV-1 RNA < 50 copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Prior use of any long acting parenteral antiretrovirals (ARVs) such as monoclonal antibodies, broadly neutralizing antibodies targeting HIV-1, LEN, injectable cabotegravir (including oral cabotegravir lead-in), and/or injectable rilpivirine.
Documented resistance to the integrase strand-transfer inhibitor class, specifically, resistance-associated mutations E92G/Q, G118R, F121Y, Y143C/H/R, S147G, Q148H/K/R, N155H/S, or R263K in the integrase gene.
Any of the following laboratory values at screening:
Active or occult hepatitis B virus infection.
Active hepatitis C virus infection.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB 1917 Research Clinic | Birmingham | Alabama | 35222 | United States | ||
| The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center |
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| Label | URL |
|---|---|
| Gilead Clinical Trials Website | View source |
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Phase 2 of the study has 2 periods: Randomized and Extension, which are both open label.
Phase 3 of the study has 2 periods: Randomized Period which would be double-blind (at least Week 96), followed by an Extension Period which will be Open-label.
Participants will receive a 1-day loading dose of lepetegravir/lenacapavir pacfosacil FDC on Day 1. Thereafter, participants will receive lepetegravir/lenacapavir pacfosacil FDC tablets weekly + placebo to match (PTM) B/F/TAF once daily. Participants will receive treatment for at least 96 weeks.
|
| Phase 3: B/F/TAF + PTM lepetegravir/Lenacapavir Pacfosacil FDC (Treatment Group 2) | Active Comparator | Participants will receive oral B/F/TAF daily along with PTM lepetegravir/lenacapavir pacfosacil FDC weekly for at least 96 weeks. Additionally, participants will receive a 1-day loading dose of PTM lepetegravir/lenacapavir pacfosacil on Day 1. |
|
| Phase 3 Extension Phase: Lepetegravir/Lenacapavir Pacfosacil Fixed-dose Combination (FDC) | Experimental | 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 continue to receive lepetegravir/lenacapavir pacfosacil FDC weekly while PTM B/F/TAF will be discontinued. Phase 3 Treatment Group 2 will switch to receive lepetegravir/lenacapavir pacfosacil FDC tablets weekly. Participants in Treatment Group 2 will also receive a 1-day loading dose of lepetegravir/lenacapavir pacfosacil FDC on Extension Phase Day 1. Participants who choose to enter the Phase 3 Extension Phase will receive lepetegravir/lenacapavir pacfosacil FDC tablets until the product becomes available or until Gilead Sciences elects to discontinue the study, whichever occurs first. |
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| lenacapavir pacfosacil | Drug | Tablets administered orally without regard to food |
|
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| Bictegravir/emtricitabine/tenofovir alafenamide | Drug | Tablets administered orally without regard to food |
|
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| lepetegravir/lenacapavir pacfosacil FDC | Drug | Tablets administered orally without regard to food |
|
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| Placebo to Match BVY | Drug | Tablets administered orally without regard to food |
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| Placebo to Match GS1720/GS-4182 FDC | Drug | Tablets administered orally without regard to food |
|
| Week 48 |
| Phase 2: Change From Baseline in log10 HIV-1 RNA at Week 12 | Baseline, Week 12 |
| Phase 2: Change From Baseline in log10 HIV-1 RNA at Week 24 | Baseline, Week 24 |
| Phase 2: Change From Baseline in log10 HIV-1 RNA at Week 48 | Baseline, Week 48 |
| Phase 2: Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 12 | Baseline, Week 12 |
| Phase 2: Change From Baseline in CD4 Cell Count at Week 24 | Baseline, Week 24 |
| Phase 2: Change From Baseline in CD4 Cell Count at Week 48 | Baseline, Week 48 |
| Phase 2: Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) Through Week 12 | First dose date up to Week 12 |
| Phase 2: Percentage of Participants Experiencing TEAEs Through Week 24 | First dose date up to Week 24 |
| Phase 2: Percentage of Participants Experiencing TEAEs Through Week 48 | First dose date up to Week 48 |
| Phase 2: Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities Through Week 12 | First dose date up to Week 12 |
| Phase 2: Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities Through Week 24 | First dose date up to Week 24 |
| Phase 2: Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities Through Week 48 | First dose date up to Week 48 |
| Phase 2: Pharmacokinetic (PK) Parameter: Cmax of Lepetegravir and Lenacapavir (LEN), as Applicable | Cmax is defined as the maximum observed concentration of drug. | Day 1 up to Week 24 |
| Phase 2: PK Parameter: Tmax of Lepetegravir and LEN, as Applicable | Tmax is defined as the time (observed time point) of Cmax. | Day 1 up to Week 24 |
| Phase 2: PK Parameter: Ctau of Lepetegravir and LEN, as Applicable | Ctau is defined as the observed drug concentration at the end of the dosing interval. | Day 1 up to Week 24 |
| Phase 2: PK Parameter: AUCtau of Lepetegravir and LEN, as Applicable | AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). | Day 1 up to Week 24 |
| Phase 3: Proportion of Participants With HIV-1 RNA < 50 copies/mL at Week 96 as Determined by the US FDA-defined Snapshot Algorithm | Week 96 |
| Phase 3: Change From Baseline in log10 HIV-1 RNA at Week 48 | Baseline, Week 48 |
| Phase 3: Change From Baseline in log10 HIV-1 RNA at Week 96 | Baseline, Week 96 |
| Phase 3: Change From Baseline in CD4 Cell Count at Week 48 | Baseline, Week 48 |
| Phase 3: Change From Baseline in CD4 Cell Count at Week 96 | Baseline, Week 96 |
| Phase 3: Percentage of Participants Experiencing TEAEs Through Week 48 | First dose date up to Week 48 |
| Phase 3: Percentage of Participants Experiencing TEAEs Through Week 96 | First dose date up to Week 96 |
| Phase 3: Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities Through Week 48 | First dose date up to Week 48 |
| Phase 3: Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities Through Week 96 | First dose date up to Week 96 |
| Torrance |
| California |
| 90502 |
| United States |
| Mills Clinical Research | West Hollywood | California | 90046 | United States |
| Georgetown University Medical School | Washington D.C. | District of Columbia | 20007 | United States |
| Midland Florida Clinical Research Center, LLC | DeLand | Florida | 32720 | United States |
| Midway Immunology and Research Center | Ft. Pierce | Florida | 34982 | United States |
| Floridian Clinical Research, LLC | Miami Lakes | Florida | 33016 | United States |
| Orlando Immunology Center | Orlando | Florida | 32803 | United States |
| Triple O Research Institute, P.A. | West Palm Beach | Florida | 33407 | United States |
| Emory University Hospital Midtown Infectious Disease Clinic | Atlanta | Georgia | 30308 | United States |
| Mercer University, Department of Internal Medicine | Macon | Georgia | 31201 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| Saint Michael's Medical Center | Newark | New Jersey | 07102 | United States |
| NYU Langone Health Vaccine Center | New York | New York | 10016 | United States |
| Medical University of South Carolina (MUSC) Research Nexus | Charleston | South Carolina | 29425 | United States |
| St Hope Foundation, Inc. | Bellaire | Texas | 77401 | United States |
| Prism Health North Texas, Aids Arms | Dallas | Texas | 75208 | United States |
| North Texas Infectious Diseases Consultants, PA | Dallas | Texas | 75246 | United States |
| Texas Centers for Infectious Disease Associates | Fort Worth | Texas | 76104 | United States |
| UT Health San Antonio | San Antonio | Texas | 78229 | United States |
| MultiCare Rockwood Main Clinic | Spokane | Washington | 99202 | United States |
| Clinique Médicale L'Actuel | Montreal | H2L 4P9 | Canada |
| Chronic Viral Illness Service / McGill University Health Centre | Montreal | H4A 3J1 | Canada |
| Ottawa Hospital Research Institute | Ottawa | K1H 8L6 | Canada |
| Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I, Immunologische Studienambulanz | Bonn | 53127 | Germany |
| Universitätsmedizin Essen, Universitätsklinikum Essen, Klinik für Dermatologie, Venerologie und Allergologie, HPSTD-Ambulanz | Essen | 45122 | Germany |
| ICH Study Center GmbH & Co. KG | Hamburg | 20146 | Germany |
| Medizinische Hochschule Hannover, Klinik für Rheumatologie und Immunologie, Gebäude K14 | Hanover | 30625 | Germany |
| Klinikum rechts der Isar, Technische Universität München, Klinik und Poliklinik für Innere Medizin II | München | 81675 | Germany |
| Wojewódzki Szpital Obserwacyjno-Zakaźny im. Tadeusza Browicza | Bydoszcz | 85-030 | Poland |
| Punkt Zdrowia | Gdansk | 80-172 | Poland |
| Samodzielny Publiczny Wojewódzki Szpital Zespolony w Szczecinie | Szczecin | 71-455 | Poland |
| Unidade Local de Saude de Amadora Sinatra EPE, Hospital Prof. Doutor Fernando Fonseca | Amadora | 2720- 276 | Portugal |
| Unidade Local de Saúde de Lisboa Ocidental E.P.E. - Hospital Egas Moniz | Lisbon | 1249-019 | Portugal |
| Unidade Local de Saúde de Santo Maria E.P.E. - Hospital Santa Maria | Lisbon | 1649-035 | Portugal |
| Unidade Local de Saúde de Santo António, E.P.E. | Porto | 4050 | Portugal |
| Unidade Local de Saúde de São João E.P.E. | Porto | 4200-319 | Portugal |
| HOPE Clinical Research | San Juan | PR | 00909 | Puerto Rico |
| Proyecto ACTU | San Juan | PR | 00935 | Puerto Rico |
| Institutul National De Boli Infectioase Prof. Dr. Matei Bals | Bucharest | 021105 | Romania |
| Spitalul Clinic De Urgenta Prof Dr Agrippa Ionescu | Bucharest | Romania |
| Spitalul Clinic De Boli Infectioase Cluj-Napoca | Cluj-Napoca | 400003 | Romania |
| Spitalul Clinic de Boli Infectioase Constanta | Constanța | 00709 | Romania |
| Clinical Hospital of Infectious Diseases and Pneumophysiology Dr. Victor Babes Timisoara | Timișoara | Romania |
| JOSHA Research | Bloemfontein | 9301 | South Africa |
| Durban International Clinical Research Site, Enhancing Care Foundation | Durban | 4013 | South Africa |
| Synergy Biomed Research Institute | East London | 5241 | South Africa |
| CRISMO Research Center | Germiston | 1401 | South Africa |
| WITS RHI Research Centre | Johannesburg | 2038 | South Africa |
| Clinical Research Institute of South Africa (CRISA) | KwaZulu-Natal | 4449 | South Africa |
| FPD Ndevana Community Research Site | Ndevana | 5660 | South Africa |
| The Aurum Institute Tembisa Clinic 4 | Tembisa | 1632 | South Africa |
| Hospital Clinic de Barcelona | Barcelona | 8036 | Spain |
| Hospital Clinico San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario Fundación Jiménez Díaz | Madrid | 28040 | Spain |
| Hospital Universitario Virgen de la Victoria | Málaga | 29010 | Spain |
| Hospital Universitario Alvaro Cunqueiro | Pontevedra | 36312 | Spain |
| Hospital Arnau de Vilanova de Valencia | Valencia | 46015 | Spain |
| ID | Term |
|---|---|
| C000654125 | bictegravir, emtricitabine, tenofovir alafenamide, drug combination |
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