Clinical Trials List
Protocol NumberGS-US-536-5938
NCT Number(ClinicalTrials.gov Identfier)NCT07682961
Not yet recruiting
2026-07-01 - 2033-11-30
Phase III
Not yet recruiting1
A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Switching to Long-acting Antiretroviral Therapy of Broadly Neutralizing Antibodies Teropavimab and Zinlirvimab in Combination With the Capsid Inhibitor Lenacapavir Twice-Yearly Versus Cabotegravir and Rilpivirine Every 8 Weeks in Virologically Suppressed Adults With HIV-1 on Oral Daily Antiretroviral Therapy
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Trial Applicant
GILEAD SCIENCES HONG KONG LIMITED
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Sponsor
-
Trial scale
Multi-Regional Multi-Center
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Update
2026/09/08
Investigators and Locations
Co-Principal Investigator
Principal Investigator
Nan-Yao Lee
Co-Principal Investigator
- 李佳雯 Division of Infectious Disease
- 冉浩恩 Division of Infectious Disease
- 李明吉 Division of Infectious Disease
- 蔡文嘉 Division of Infectious Disease
- 薛伶珊 Division of Infectious Disease
- Po-Lin Chen Division of Infectious Disease
- 羅景霳 Division of Infectious Disease
- Wen-Chien Ko Division of Infectious Disease
- 游天瑜 Division of Infectious Disease
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
HIV Infections
Objectives
主要目標
•在病毒抑制 HIV-1 感染患者 (PWH) 中，評估改用 lenacapavir (LEN)、teropavimab（TAB；GS-5423）與 zinlirvimab（ZAB；GS-2872）療程相較於改用 cabotegravir (CAB) 與 rilpivirine (RPV) 的療效，判定依據為第 52 週時 HIV-1 RNA ≥ 50 copies/mL 的受試者比例。
次要目標
•在第 52 週和 92 週時，透過 HIV-1 RNA 和 CD4+ T 細胞計數，評估改用 LEN + TAB + ZAB 療程相較於改用 CAB + RPV 的療效。
•評估 2 種試驗治療療程（LEN + TAB + ZAB 與 CAB + RPV）的安全性和耐受性。
•評估 LEN、TAB 和 ZAB 的藥物動力學 (PK)。
•評估 TAB 和 ZAB 的免疫原性。
探索性目標
•透過 HIV-1 RNA 和 CD4+T 細胞計數，評估 LEN + TAB + ZAB 的長期療效。
•評估試驗治療期間產生的病毒抗藥性。
•評估 2 個治療組透過下列方式所測得的患者報告結果 (PRO)：修正版 PozQoL、瞭解 HIV 介入試驗中的體驗和滿意度問卷、HIV 介入偏好問卷、HIV 臨床試驗期望問卷、患者對嚴重程度的整體印象、患者對變化的整體印象以及 EuroQoL 5 面向 3 等級問卷。
•評估 2 個治療組的依從性。
•評估 2 個治療組之間 HIV 病毒庫的變化。
Test Drug
膜衣錠
注射劑
靜脈輸注液
靜脈輸注液
注射劑
靜脈輸注液
靜脈輸注液
Active Ingredient
Lenacapavir
Teropavimab
Zinlirvimab
Teropavimab
Zinlirvimab
Dosage Form
116
270
246
246
270
246
246
Dosage
300 mg
309 mg/mL
85 mg/mL
309 mg/mL
85 mg/mL
Endpoints
依據美國 (US) 食品藥物管理局 (FDA) 快照演算法定義，在第 52 週時 HIV-1 RNA ≥ 50 copies/mL 的受試者比例。
Inclution Criteria
Key Inclusion Criteria:
Human immunodeficiency virus type 1 (HIV-1) susceptibility results from screening meeting specific criteria:
1) Proviral phenotypic susceptibility to both TAB and ZAB by the investigational protocol-defined assay at screening.
At least 1 documented HIV-1 RNA level measured between 6 months and 12 months (+2 months) prior to screening. This and any other HIV-1 RNA measurements documented in this period must be < 50 copies/mL (undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL). A single virologic elevation of ≥ 50 copies/mL and < 400 copies/mL (transient detectable viremia or "blips") prior to screening are acceptable if the subsequent plasma HIV-1 RNA level is < 50 copies/mL.
A plasma HIV-1 RNA test < 50 copies/mL (undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL) within the last 6 months prior to screening.
1) If > 1 plasma HIV-1 RNA measurements in the last 6 months prior to screening are available, all must be < 50 copies/mL (undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL).
On a stable oral ARV therapy (ART) for ≥ 6 months prior to screening.
A change in ART regimen ≥ 3 months prior to the screening visit for reasons other than virologic failure (VF) (eg, tolerability, simplification, drug-drug interaction profile) is allowed; individuals with a change in ART regimen ≥ 3 months prior to screening must have been on the regimen for ≥ 3 months prior to screening, and all HIV-1 RNA measurements in that period must be < 50 copies/mL. There are no permitted changes to ART regimens between screening and Day 1.
Human immunodeficiency virus type 1 (HIV-1) susceptibility results from screening meeting specific criteria:
1) Proviral phenotypic susceptibility to both TAB and ZAB by the investigational protocol-defined assay at screening.
At least 1 documented HIV-1 RNA level measured between 6 months and 12 months (+2 months) prior to screening. This and any other HIV-1 RNA measurements documented in this period must be < 50 copies/mL (undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL). A single virologic elevation of ≥ 50 copies/mL and < 400 copies/mL (transient detectable viremia or "blips") prior to screening are acceptable if the subsequent plasma HIV-1 RNA level is < 50 copies/mL.
A plasma HIV-1 RNA test < 50 copies/mL (undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL) within the last 6 months prior to screening.
1) If > 1 plasma HIV-1 RNA measurements in the last 6 months prior to screening are available, all must be < 50 copies/mL (undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL).
On a stable oral ARV therapy (ART) for ≥ 6 months prior to screening.
A change in ART regimen ≥ 3 months prior to the screening visit for reasons other than virologic failure (VF) (eg, tolerability, simplification, drug-drug interaction profile) is allowed; individuals with a change in ART regimen ≥ 3 months prior to screening must have been on the regimen for ≥ 3 months prior to screening, and all HIV-1 RNA measurements in that period must be < 50 copies/mL. There are no permitted changes to ART regimens between screening and Day 1.
Exclusion Criteria
Key Exclusion Criteria:
History of an opportunistic infection or illness indicative of Stage 3 HIV disease.
History of treatment failure.
Known or suspected resistance to either CAB or RPV.
Resistance to CAB defined as the following mutations: G118R, Q148K, Q148R, T66K+L74M, E92Q+N155H, E138A+Q148R, E138K+Q148K/R, G140C+Q148R, G140S+Q148H/K/R, Y143H+N155H, and Q148R+N155H.
Resistance to RPV defined as the following mutations: K101E and P; E138A, G, K, R, and Q; V179L; Y181C, I, and V; Y188L; H221Y; F227C; M230I and L, and the combination of L100I/K103N.
Individuals with a dermatologic condition or implanted prothesis overlying the gluteal injection site for CAB + RPV.
Known hypersensitivity to the study intervention, its metabolites, or formulation excipients.
Active, serious infections (other than HIV-1) requiring therapy < 30 days prior to randomization.
Active tuberculosis infection.
Acute hepatitis of any cause < 30 days before randomization.
History of, or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, or variceal bleeding) or severe hepatic impairment (Child-Pugh Class C).
Active malignancy requiring acute systemic therapy.
Have poor venous access that would limit phlebotomy or intravenous (IV) infusion of study drugs.
Prior use of, or exposure to, LEN or a broadly neutralizing antibody (bNAb) for HIV-1.
Prior use of, or exposure to, long-acting (LA) injectable CAB or LA injectable RPV.
Prior use of, or exposure to, ibalizumab, fostemsavir, or maraviroc.
Baseline regimen consisting of monotherapy with any single antiretroviral (ARV).
Treatment with immunosuppressant therapies (eg, corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies) within 4 weeks of screening (with the exception of a single short course of corticosteroids lasting ≤ 7 days) or have a comorbid condition with an anticipated need ongoing immunosuppressive treatment during the study.
Hepatitis C virus (HCV) antibody positive and HCV RNA detectable.
Chronic hepatitis B virus (HBV) infection, as determined by either:
Positive HBV surface antigen and negative HBV surface antibody, regardless of HBV core antibody status, at the screening visit.
Positive HBV core antibody and negative HBV surface antibody, regardless of HBV surface antigen status, at the screening visit.
Severe renal impairment-estimated glomerular filtration rate < 30 mL/min according to the Cockcroft-Gault formula.
Abnormal electrocardiogram (ECG) at the screening visit that is clinically significant, as determined by the investigator.
Any of the following laboratory values at screening:
Alanine aminotransferase > 5 x upper limit of normal (ULN).
Direct bilirubin > 1.5 x ULN.
Platelets < 50,000/mm^3.
Hemoglobin < 8.0 g/dL.
History of an opportunistic infection or illness indicative of Stage 3 HIV disease.
History of treatment failure.
Known or suspected resistance to either CAB or RPV.
Resistance to CAB defined as the following mutations: G118R, Q148K, Q148R, T66K+L74M, E92Q+N155H, E138A+Q148R, E138K+Q148K/R, G140C+Q148R, G140S+Q148H/K/R, Y143H+N155H, and Q148R+N155H.
Resistance to RPV defined as the following mutations: K101E and P; E138A, G, K, R, and Q; V179L; Y181C, I, and V; Y188L; H221Y; F227C; M230I and L, and the combination of L100I/K103N.
Individuals with a dermatologic condition or implanted prothesis overlying the gluteal injection site for CAB + RPV.
Known hypersensitivity to the study intervention, its metabolites, or formulation excipients.
Active, serious infections (other than HIV-1) requiring therapy < 30 days prior to randomization.
Active tuberculosis infection.
Acute hepatitis of any cause < 30 days before randomization.
History of, or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, or variceal bleeding) or severe hepatic impairment (Child-Pugh Class C).
Active malignancy requiring acute systemic therapy.
Have poor venous access that would limit phlebotomy or intravenous (IV) infusion of study drugs.
Prior use of, or exposure to, LEN or a broadly neutralizing antibody (bNAb) for HIV-1.
Prior use of, or exposure to, long-acting (LA) injectable CAB or LA injectable RPV.
Prior use of, or exposure to, ibalizumab, fostemsavir, or maraviroc.
Baseline regimen consisting of monotherapy with any single antiretroviral (ARV).
Treatment with immunosuppressant therapies (eg, corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies) within 4 weeks of screening (with the exception of a single short course of corticosteroids lasting ≤ 7 days) or have a comorbid condition with an anticipated need ongoing immunosuppressive treatment during the study.
Hepatitis C virus (HCV) antibody positive and HCV RNA detectable.
Chronic hepatitis B virus (HBV) infection, as determined by either:
Positive HBV surface antigen and negative HBV surface antibody, regardless of HBV core antibody status, at the screening visit.
Positive HBV core antibody and negative HBV surface antibody, regardless of HBV surface antigen status, at the screening visit.
Severe renal impairment-estimated glomerular filtration rate < 30 mL/min according to the Cockcroft-Gault formula.
Abnormal electrocardiogram (ECG) at the screening visit that is clinically significant, as determined by the investigator.
Any of the following laboratory values at screening:
Alanine aminotransferase > 5 x upper limit of normal (ULN).
Direct bilirubin > 1.5 x ULN.
Platelets < 50,000/mm^3.
Hemoglobin < 8.0 g/dL.
The Estimated Number of Participants
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Taiwan
40 participants
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Global
590 participants
