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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-511054-50 | Other Identifier | European Medicines Agency |
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The goal of this clinical study is to learn more about the experimental drugs lepetegravir and lenacapavir pacfosacil; to compare the combination of lepetegravir and lenacapavir pacfosacil with the current standard-of-care treatment bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF, BVY), 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.
This study has two phases: Phase 2 and Phase 3.
The primary objectives of this study are:
Phase 2: To evaluate the efficacy of switching to oral weekly lepetegravir in combination with lenacapavir pacfosacil versus continuing BVY in virologically suppressed people with HIV-1 (PWH) at Week 24.
Phase 3: To evaluate the efficacy of switching to oral weekly lepetegravir /lenacapavir pacfosacil Fixed-dose combination (FDC) tablet regimen versus continuing BVY in virologically suppressed PWH at Week 48.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 2: Lepetegravir + Lenacapavir pacfosacil (Treatment Group 1) | Experimental | Participants who have been virologically suppressed on bictegravir/emtricitabine/tenofovir alafenamide (BVY) will switch to lepetegravir (650 mg tablet) and lenacapavir pacfosacil (300 mg tablet) coadministered. 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. |
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| Phase 2: Bictegravir/emtricitabine/tenofovir alafenamide (BVY) (Treatment Group 2) | Active Comparator | Participants who have been virologically suppressed on bictegravir/emtricitabine/tenofovir alafenamide (BVY) will continue receiving BVY daily for at least 48 weeks. |
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| 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 weekly. Phase 2 Treatment Group 2 will receive a loading dose of lepetegravir /lenacapavir pacfosacil FDC on Extension Phase Day 1 then, lepetegravir/lenacapavir pacfosacil FDC 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lepetegravir | Drug | Tablets administered orally without regard to food |
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| 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, or exposure to LEN, lepetegravir, or lenacapavir pacfosacil.
History of virologic failure while on an integrase strand-transfer inhibitor (INSTI)-based regimen.
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.
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.
Any of the following laboratory values at screening:
Active or occult hepatitis B virus (HBV) infection.
Active hepatitis C virus (HCV).
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 | 35294 | United States | ||
| Pacific Oaks Medical Group |
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| Label | URL |
|---|---|
| Gilead Clinical Trials Website | View source |
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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.
| Phase 3: Lepetegravir /Lenacapavir pacfosacil FDC + Placebo to Match (PTM) BVY (Treatment Group 1) | Experimental | Participants who have been virologically suppressed on BVY will switch from BVY to lepetegravir/lenacapavir pacfosacil FDC tablets weekly + placebo-to-match (PTM) BVY once daily. In addition, participants will receive a 1-day loading dose regimen of lepetegravir /lenacapavir pacfosacil FDC on Day 1. Participants will receive treatment for at least 96 weeks. |
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| Phase 3: BVY Placebo to Match Lepetegravir /Lenacapavir pacfosacil FDC + BVY (Treatment Group 2) | Active Comparator | 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 lepetegravir /lenacapavir pacfosacil on Day 1 and weekly PTM thereafter. Participants will receive treatment for at least 96 weeks. |
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| 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 switch to lepetegravir/lenacapavir pacfosacil FDC weekly. Phase 3 Treatment Group 2 will receive a 1-day loading dose of lepetegravir/lenacapavir pacfosacil FDC on Extension Phase Day 1, then lepetegravir/lenacapavir pacfosacil FDC 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. |
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| Lenacapavir pacfosacil | 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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| 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 GS1720/GS-4182 FDC | Drug | Tablets administered orally without regard to food |
|
| Week 48 |
| 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 24 as Determined by the US FDA-defined Snapshot Algorithm | Week 24 |
| Phase 2: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm | Week 48 |
| Phase 2: Change From Baseline in Clusters of Differentiation 4 (CD4+) T-cell Count at Week 12 | Baseline, Week 12 |
| Phase 2: Change From Baseline in CD4+ T-cell Count at Week 24 | Baseline, Week 24 |
| Phase 2: Change From Baseline in CD4+ T-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) | Cmax is defined as the maximum observed concentration of drug. | Day 1 up to Week 48 |
| Phase 2: PK Parameter: Tmax of Lepetegravir and LEN | Tmax is defined as the time (observed time point) of Cmax. | Day 1 up to Week 48 |
| Phase 2: PK Parameter: Ctau of Lepetegravir and LEN | Ctau is defined as the observed drug concentration at the end of the dosing interval. | Day 1 up to Week 48 |
| Phase 2: PK Parameter: AUCtau of Lepetegravir and LEN | 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 48 |
| 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: Proportion of Participants With HIV-1 RNA < 50 copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm | Week 48 |
| 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 CD4+ T-cell Count at Week 48 | Baseline, Week 48 |
| Phase 3: Change From Baseline in CD4+ T-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: Proportion 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 |
| Beverly Hills |
| California |
| 90211 |
| United States |
| Ruane Clinical Research Group | Los Angeles | California | 90036 | United States |
| Mills Clinical Research | Los Angeles | California | 90069 | United States |
| BIOS Clinical Research | Palm Springs | California | 92262 | United States |
| UCSF Division of HIV, Infectious Diseases & Global Medicine | San Francisco | California | 94110 | United States |
| Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Torrance | California | 90502 | United States |
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | United States |
| Midland Florida Clinical Research Center, LLC | DeLand | Florida | 32720 | United States |
| CAN Community Health | Fort Lauderdale | Florida | 33316 | United States |
| Midway and Immunology Research Center | Ft. Pierce | Florida | 34982 | United States |
| AIDS Healthcare Foundation - The Kinder Medical Group | Miami | Florida | 33133 | United States |
| Floridian Clinical Research | Miami Lakes | Florida | 33016 | United States |
| Orlando Immunology Center | Orlando | Florida | 32803 | United States |
| CAN Community Health | Sarasota | Florida | 34237 | United States |
| Triple O Research Institute, P.A. | West Palm Beach | Florida | 33407 | United States |
| Metro Infectious Disease Consultants, P.L.L.C. | Decatur | Georgia | 30033 | United States |
| Mercer University, Department of Internal Medicine | Macon | Georgia | 31201 | United States |
| Chatham County Health Department | Savannah | Georgia | 31401 | United States |
| Be Well Medical Center | Berkley | Michigan | 48072 | United States |
| KC CARE Health Center | Kansas City | Missouri | 64111 | United States |
| Saint Michael's Medical Center | Newark | New Jersey | 07102 | United States |
| AXCES Research Group, LLC | Santa Fe | New Mexico | 87505 | United States |
| NewYork-Presbyterian Queens | Flushing | New York | 11355 | United States |
| NYU Langone Health Vaccine Center | New York | New York | 10016 | United States |
| Rosedale Health and Wellness | Huntersville | North Carolina | 28078 | United States |
| Central Texas Clinical Research | Austin | Texas | 78705 | United States |
| St Hope Foundation, Inc. | Bellaire | Texas | 77401 | United States |
| Prism Health North Texas, Oak Cliff Health Center | Dallas | Texas | 75215 | United States |
| North Texas Infectious Diseases Consultants, PA | Dallas | Texas | 75246 | United States |
| AXCES Research Group, LLC | El Paso | Texas | 79902 | United States |
| Texas Centers for Infectious Disease Associates | Fort Worth | Texas | 76104 | United States |
| The Crofoot Research Center, INC. | Houston | Texas | 77098 | United States |
| DCOL Center for Clinical Research | Longview | Texas | 75605 | United States |
| Peter Shalit, MD | Seattle | Washington | 98104 | United States |
| Centro Ararat, Inc. | San Juan | PR | 00717 | Puerto Rico |
| Clinical Research Puerto Rico | San Juan | PR | 00909-1711 | Puerto Rico |
| HOPE Clinical Research | San Juan | PR | 00909 | Puerto Rico |
| Proyecto ACTC | San Juan | PR | 00935 | Puerto Rico |
| ID | Term |
|---|---|
| C000654125 | bictegravir, emtricitabine, tenofovir alafenamide, drug combination |
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