計劃書編號GS-US-621-6289
試驗執行中
2022-10-27 - 2030-01-21
Phase II/III
尚未開始4
一項連續操作的第 2/3 期、隨機分配、開放性、多中心、活性藥物對照試驗，在病毒抑制且接受穩定複合治療療程之人類免疫不全病毒 (HIV)-1 患者中評估 Bictegravir/Lenacapavir 相較於穩定基準期療程的安全性與療效
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試驗申請者
香港商吉立亞醫藥有限公司台灣分公司
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試驗委託 / 贊助單位名稱
香港商吉立亞醫藥有限公司台灣分公司
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臨床試驗規模
多國多中心
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更新日期
2026/02/01
試驗主持人及試驗醫院
適應症
人類免疫不全病毒 (HIV)-1感染
試驗目的
主要目標
第 2 期：
•依據第 24 週 HIV-1 核糖核酸 (RNA) ≥ 50 拷貝數/mL 的參與者比例的判定，在病毒抑制之 HIV 患者 (PWH) 評估轉換至 bictegravir (BIC) 加上 lenacapavir (LEN) 療程 (BIC 75 mg 加上 LEN 25 mg 或 BIC 75 mg 加上 LEN 50 mg) 相較於繼續接受穩定基準期療程 (SBR) 的療效。
第 3 期：
•依據第 48 週 HIV-1 RNA ≥ 50 拷貝數/mL 的參與者比例的判定，在病毒抑制之 PWH 評估轉換至 BIC/LEN 固定劑量組合 (FDC) 藥錠療程 (BIC 50 至 75 mg/LEN 25 或 50 mg) 相較於繼續接受 SBR 的療效。
次要目標
第 2 期：
•依據第 24 週病毒量抑制率及 CD4 細胞計數的判定，評估病毒抑制之 PWH 的 3 種治療療程療效。
•評估 3 個治療組直至第 24 週的安全性及耐受性。
•對於接受 BIC 75 mg 加上 LEN 25 mg 和 BIC 75 mg 加上 LEN 50 mg 的參與者，評估 BIC 和 LEN 的藥物動力學 (PK)。
第 3 期：
•依據第 48 週病毒量抑制率及 CD4 細胞計數的判定，評估病毒抑制之 PWH 的 2 個治療組療效。
•評估 2 個治療組直至第 48 週的安全性及耐受性。
探索性目標
第 3 期
•針對接受 BIC/LEN FDC 藥錠療程 (BIC 50 至 75 mg/LEN 25 或 50 mg) 的參與者，評估 BIC 和 LEN 的 PK。
•評估 2 個治療組對於治療滿意度和健康相關生活品質 (HRQOL) 的影響。
藥品名稱
錠劑
錠劑
錠劑
主成份
Bictegravir sodium
Lenacapavir sodium salt
Lenacapavir sodium salt
劑型
110
110
110
劑量
75 mg
25 mg, 50 mg, 300 mg
25 mg, 50 mg, 300 mg
評估指標
第 2 期：
• 依據美國食品藥物管理局 (FDA) 定義的快照演算法，判定第 24 週 HIV-1 RNA ≥ 50 拷貝數/mL 的參與者比例。
第 3 期：
• 依據美國 FDA 定義的快照演算法，判定第 48 週 HIV-1 RNA ≥ 50 拷貝數/mL 的參與者比例。
• 依據美國食品藥物管理局 (FDA) 定義的快照演算法，判定第 24 週 HIV-1 RNA ≥ 50 拷貝數/mL 的參與者比例。
第 3 期：
• 依據美國 FDA 定義的快照演算法，判定第 48 週 HIV-1 RNA ≥ 50 拷貝數/mL 的參與者比例。
主要納入條件
Participants must meet all of the following inclusion criteria to be eligible for participation in this
study:
1) Willing and able to provide written informed consent prior to performing study procedures.
2) Aged ≥ 18 years at screening.
3) Participants assigned female at birth and of childbearing potential who engage in
heterosexual intercourse must agree to use protocol-specified method(s) of contraception as
described in Appendix 11.4.
4) Documented plasma HIV-1 RNA levels ＜ 50 copies/mL during treatment with the baseline
regimen for a minimum period of 6 months prior to the screening visit.
5) Plasma HIV-1 RNA levels ＜ 50 copies/mL at screening.
6) Currently receiving a complex ARV regimen due to previous viral resistance, or intolerance,
or contraindication to existing STRs. The criteria to define a complex regimen in this study
are as follows:
A regimen containing a boosted protease inhibitor or a nonnucleos(t)ide reverse
transcriptase inhibitor plus at least 1 other third agent (ie, an agent from a class other than
NRTIs) (eg, BVY + darunavir/cobicistat, BVY + etravirine), or
A regimen of ≥ 2 pills/day, or a regimen requiring dosing more than once daily, or
A regimen containing parenteral agent(s) (excluding a complete long-acting injectable
regimen, such as intramuscular cabotegravir plus rilpivirine) as well as oral agents.
7) No documented or suspected resistance to BIC (T66A/I/K, E92G/Q, G118R,
F121Y, Y143C/H/R, S147G, Q148H/K/R, N155H/S, or R263K in the integrase gene).
8) Estimated glomerular filtration rate ≥ 15 mL/min according to the Cockcroft-Gault formula
for creatinine clearance (CLcr) {Cockcroft 1976} who are not on renal replacement therapy.
study:
1) Willing and able to provide written informed consent prior to performing study procedures.
2) Aged ≥ 18 years at screening.
3) Participants assigned female at birth and of childbearing potential who engage in
heterosexual intercourse must agree to use protocol-specified method(s) of contraception as
described in Appendix 11.4.
4) Documented plasma HIV-1 RNA levels ＜ 50 copies/mL during treatment with the baseline
regimen for a minimum period of 6 months prior to the screening visit.
5) Plasma HIV-1 RNA levels ＜ 50 copies/mL at screening.
6) Currently receiving a complex ARV regimen due to previous viral resistance, or intolerance,
or contraindication to existing STRs. The criteria to define a complex regimen in this study
are as follows:
A regimen containing a boosted protease inhibitor or a nonnucleos(t)ide reverse
transcriptase inhibitor plus at least 1 other third agent (ie, an agent from a class other than
NRTIs) (eg, BVY + darunavir/cobicistat, BVY + etravirine), or
A regimen of ≥ 2 pills/day, or a regimen requiring dosing more than once daily, or
A regimen containing parenteral agent(s) (excluding a complete long-acting injectable
regimen, such as intramuscular cabotegravir plus rilpivirine) as well as oral agents.
7) No documented or suspected resistance to BIC (T66A/I/K, E92G/Q, G118R,
F121Y, Y143C/H/R, S147G, Q148H/K/R, N155H/S, or R263K in the integrase gene).
8) Estimated glomerular filtration rate ≥ 15 mL/min according to the Cockcroft-Gault formula
for creatinine clearance (CLcr) {Cockcroft 1976} who are not on renal replacement therapy.
主要排除條件
Participants must meet all of the following inclusion criteria to be eligible for participation in this
study:
1) Willing and able to provide written informed consent prior to performing study procedures.
2) Aged ≥ 18 years at screening.
3) Participants assigned female at birth and of childbearing potential who engage in
heterosexual intercourse must agree to use protocol-specified method(s) of contraception as
described in Appendix 11.4.
4) Documented plasma HIV-1 RNA levels ＜ 50 copies/mL during treatment with the baseline
regimen for a minimum period of 6 months prior to the screening visit.
5) Plasma HIV-1 RNA levels ＜ 50 copies/mL at screening.
6) Currently receiving a complex ARV regimen due to previous viral resistance, or intolerance,
or contraindication to existing STRs. The criteria to define a complex regimen in this study
are as follows:
A regimen containing a boosted protease inhibitor or a nonnucleos(t)ide reverse
transcriptase inhibitor plus at least 1 other third agent (ie, an agent from a class other than
NRTIs) (eg, BVY + darunavir/cobicistat, BVY + etravirine), or
A regimen of ≥ 2 pills/day, or a regimen requiring dosing more than once daily, or
A regimen containing parenteral agent(s) (excluding a complete long-acting injectable
regimen, such as intramuscular cabotegravir plus rilpivirine) as well as oral agents.
7) No documented or suspected resistance to BIC (T66A/I/K, E92G/Q, G118R,
F121Y, Y143C/H/R, S147G, Q148H/K/R, N155H/S, or R263K in the integrase gene).
8) Estimated glomerular filtration rate ≥ 15 mL/min according to the Cockcroft-Gault formula
for creatinine clearance (CLcr) {Cockcroft 1976} who are not on renal replacement therapy.
study:
1) Willing and able to provide written informed consent prior to performing study procedures.
2) Aged ≥ 18 years at screening.
3) Participants assigned female at birth and of childbearing potential who engage in
heterosexual intercourse must agree to use protocol-specified method(s) of contraception as
described in Appendix 11.4.
4) Documented plasma HIV-1 RNA levels ＜ 50 copies/mL during treatment with the baseline
regimen for a minimum period of 6 months prior to the screening visit.
5) Plasma HIV-1 RNA levels ＜ 50 copies/mL at screening.
6) Currently receiving a complex ARV regimen due to previous viral resistance, or intolerance,
or contraindication to existing STRs. The criteria to define a complex regimen in this study
are as follows:
A regimen containing a boosted protease inhibitor or a nonnucleos(t)ide reverse
transcriptase inhibitor plus at least 1 other third agent (ie, an agent from a class other than
NRTIs) (eg, BVY + darunavir/cobicistat, BVY + etravirine), or
A regimen of ≥ 2 pills/day, or a regimen requiring dosing more than once daily, or
A regimen containing parenteral agent(s) (excluding a complete long-acting injectable
regimen, such as intramuscular cabotegravir plus rilpivirine) as well as oral agents.
7) No documented or suspected resistance to BIC (T66A/I/K, E92G/Q, G118R,
F121Y, Y143C/H/R, S147G, Q148H/K/R, N155H/S, or R263K in the integrase gene).
8) Estimated glomerular filtration rate ≥ 15 mL/min according to the Cockcroft-Gault formula
for creatinine clearance (CLcr) {Cockcroft 1976} who are not on renal replacement therapy.
試驗計畫預計收納受試者人數
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台灣人數
34 人
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全球人數
671 人
