計劃書編號GS-US-5635925
試驗執行中
2025-01-01 - 2031-01-26
Phase III
召募中5
一項評估接受 Bictegravir/Emtricitabine/Tenofovir（B/F/TAF）病毒學抑制的 HIV-1 感染者轉為每週一次口服 Islatravir/Lenacapavir 的第 3 期、隨機、雙盲、活性對照試驗
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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
實際收案人數
0 召募中
實際收案人數
0 召募中
適應症
接受 Bictegravir/Emtricitabine/Tenofovir（B/F/TAF）病毒學抑制的 HIV-1 感染者
試驗目的
主要目標
• 評估病毒學抑制的 HIV 感染者（PWH）在第 48 週時轉為每週一次口服Islatravir（ISL；MK-8591）/Lenacapavir（LEN；GS-6207）固定劑量組合（FDC）片劑方案相較於繼續接受 B/F/TAF 的療效
次要目標
• 評估病毒學抑制的 PWH 在第 48 週和第 96 週時轉為每週一次口服 ISL/LEN FDC 相較於繼續接受 B/F/TAF 的療效
• 評估每週一次口服 ISL/LEN FDC 的安全性和耐受性
藥品名稱
Biktarvy
Islatravir/Lenacapavir
Islatravir/Lenacapavir
主成份
EMTRICITABINE
Lenacapavir Sodium
Lenacapavir Sodium
劑型
116
116
116
劑量
200 mg
300 mg
300 mg
評估指標
依據美國 (US) 食品藥物管理局 (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) Participants 18 years of age or older at screening and able to understand and give written
informed consent.
2) HIV-1 RNA < 50 copies/mL for ≥ 6 months before screening, as documented by:
a) One HIV-1 RNA < 50 copies/mL immediately preceding the 24 week period prior to
screening.
b) Within 24 weeks prior to screening, if HIV-1 RNA results are available, all levels must
be < 50 copies/mL.
c) During the 6 to 12 months period prior to screening, transient detectable viremia
≥ 50 copies/mL is acceptable (“blip”), as long as it is not confirmed on 2 consecutive
visits.
3) Plasma HIV-1 RNA levels < 50 copies/mL at screening.
4) Participants are receiving B/F/TAF for ≥ 6 months prior to screening and willing to continue
until Day 1.
5) Participants assigned female at birth and of childbearing potential who engage in
heterosexual intercourse must agree to use protocol-specified methods of contraception as
described in Appendix 11.5.
Participants who meet any of the following exclusion criteria are not eligible to be enrolled in
this study:
1) Prior virologic failure.
2) Prior use of, or exposure to, ISL or LEN.
3) Active, serious infections requiring parenteral therapy within 30 days before randomization.
4) Active tuberculosis infection.
5) Acute hepatitis within 30 days before randomization.
6) HBV infection, as determined below at the screening visit:
a) Positive HBV surface antigen.
OR
b) Positive HBV core antibody and negative HBV surface antibody.
Note: participants found to be susceptible to HBV infection (eg, negative hepatitis B surface
antibody at the screening visit, regardless of prior HBV vaccination history) should be
recommended to receive HBV vaccination.
7) Active hepatitis C virus (HCV) coinfection, defined as detectable HCV RNA.
Note: participants with prior/inactive HCV infection (defined as undetectable HCV RNA)
ma8) History of or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, or
variceal bleeding).
9) Treatment < 3 months prior to screening or anticipated treatment during the study period with
immunosuppressant therapies, hydroxyurea, foscarnet, radiation, or cytotoxic
chemotherapeutic agents without approval from sponsor prior to randomization. Agents
disallowed in Section 5.3 may not be considered for sponsor approval.
10) Active malignancy requiring acute systemic therapy.
11) Abnormal electrocardiogram (ECG) at the screening visit that is clinically significant as
determined by the investigator.y be enrolled.
12) Any of the following laboratory values at screening:
a) CLcr ≤ 30 mL/min according to the Cockcroft-Gault formula {Cockcroft 1976}
b) Alanine aminotransferase > 5 upper limit of normal (ULN)
c) Direct bilirubin > 1.5 ULN
d) Platelets < 50,000/μL
e) Hemoglobin < 8.0 g/dL
13) Participation or planned participation in any other clinical study (including observational
studies) without prior approval from the sponsor.
14) Known hypersensitivity to any of the study drugs, their metabolites, or formulation
excipients.
15) Any other clinical condition or prior therapy that, in the opinion of the investigator, would
make the participant unsuitable for the study or unable to comply with dosing requirements.
16) Participants of childbearing potential (as defined in Appendix 11.5) who have a positive
serum pregnancy test at screening or positive urine and serum pregnancy tests at Day 1 prior
to study drug administration.
17) Participants who plan to continue breastfeeding during the study.
18) Requirement for ongoing therapy or use of any prohibited medications listed in Section 5.3
within 30 days prior to screening through the last dose of study drug.
study:
1) Participants 18 years of age or older at screening and able to understand and give written
informed consent.
2) HIV-1 RNA < 50 copies/mL for ≥ 6 months before screening, as documented by:
a) One HIV-1 RNA < 50 copies/mL immediately preceding the 24 week period prior to
screening.
b) Within 24 weeks prior to screening, if HIV-1 RNA results are available, all levels must
be < 50 copies/mL.
c) During the 6 to 12 months period prior to screening, transient detectable viremia
≥ 50 copies/mL is acceptable (“blip”), as long as it is not confirmed on 2 consecutive
visits.
3) Plasma HIV-1 RNA levels < 50 copies/mL at screening.
4) Participants are receiving B/F/TAF for ≥ 6 months prior to screening and willing to continue
until Day 1.
5) Participants assigned female at birth and of childbearing potential who engage in
heterosexual intercourse must agree to use protocol-specified methods of contraception as
described in Appendix 11.5.
Participants who meet any of the following exclusion criteria are not eligible to be enrolled in
this study:
1) Prior virologic failure.
2) Prior use of, or exposure to, ISL or LEN.
3) Active, serious infections requiring parenteral therapy within 30 days before randomization.
4) Active tuberculosis infection.
5) Acute hepatitis within 30 days before randomization.
6) HBV infection, as determined below at the screening visit:
a) Positive HBV surface antigen.
OR
b) Positive HBV core antibody and negative HBV surface antibody.
Note: participants found to be susceptible to HBV infection (eg, negative hepatitis B surface
antibody at the screening visit, regardless of prior HBV vaccination history) should be
recommended to receive HBV vaccination.
7) Active hepatitis C virus (HCV) coinfection, defined as detectable HCV RNA.
Note: participants with prior/inactive HCV infection (defined as undetectable HCV RNA)
ma8) History of or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, or
variceal bleeding).
9) Treatment < 3 months prior to screening or anticipated treatment during the study period with
immunosuppressant therapies, hydroxyurea, foscarnet, radiation, or cytotoxic
chemotherapeutic agents without approval from sponsor prior to randomization. Agents
disallowed in Section 5.3 may not be considered for sponsor approval.
10) Active malignancy requiring acute systemic therapy.
11) Abnormal electrocardiogram (ECG) at the screening visit that is clinically significant as
determined by the investigator.y be enrolled.
12) Any of the following laboratory values at screening:
a) CLcr ≤ 30 mL/min according to the Cockcroft-Gault formula {Cockcroft 1976}
b) Alanine aminotransferase > 5 upper limit of normal (ULN)
c) Direct bilirubin > 1.5 ULN
d) Platelets < 50,000/μL
e) Hemoglobin < 8.0 g/dL
13) Participation or planned participation in any other clinical study (including observational
studies) without prior approval from the sponsor.
14) Known hypersensitivity to any of the study drugs, their metabolites, or formulation
excipients.
15) Any other clinical condition or prior therapy that, in the opinion of the investigator, would
make the participant unsuitable for the study or unable to comply with dosing requirements.
16) Participants of childbearing potential (as defined in Appendix 11.5) who have a positive
serum pregnancy test at screening or positive urine and serum pregnancy tests at Day 1 prior
to study drug administration.
17) Participants who plan to continue breastfeeding during the study.
18) Requirement for ongoing therapy or use of any prohibited medications listed in Section 5.3
within 30 days prior to screening through the last dose of study drug.
主要排除條件
Participants must meet all of the following inclusion criteria to be eligible for participation in this
study:
1) Participants 18 years of age or older at screening and able to understand and give written
informed consent.
2) HIV-1 RNA < 50 copies/mL for ≥ 6 months before screening, as documented by:
a) One HIV-1 RNA < 50 copies/mL immediately preceding the 24 week period prior to
screening.
b) Within 24 weeks prior to screening, if HIV-1 RNA results are available, all levels must
be < 50 copies/mL.
c) During the 6 to 12 months period prior to screening, transient detectable viremia
≥ 50 copies/mL is acceptable (“blip”), as long as it is not confirmed on 2 consecutive
visits.
3) Plasma HIV-1 RNA levels < 50 copies/mL at screening.
4) Participants are receiving B/F/TAF for ≥ 6 months prior to screening and willing to continue
until Day 1.
5) Participants assigned female at birth and of childbearing potential who engage in
heterosexual intercourse must agree to use protocol-specified methods of contraception as
described in Appendix 11.5.
Participants who meet any of the following exclusion criteria are not eligible to be enrolled in
this study:
1) Prior virologic failure.
2) Prior use of, or exposure to, ISL or LEN.
3) Active, serious infections requiring parenteral therapy within 30 days before randomization.
4) Active tuberculosis infection.
5) Acute hepatitis within 30 days before randomization.
6) HBV infection, as determined below at the screening visit:
a) Positive HBV surface antigen.
OR
b) Positive HBV core antibody and negative HBV surface antibody.
Note: participants found to be susceptible to HBV infection (eg, negative hepatitis B surface
antibody at the screening visit, regardless of prior HBV vaccination history) should be
recommended to receive HBV vaccination.
7) Active hepatitis C virus (HCV) coinfection, defined as detectable HCV RNA.
Note: participants with prior/inactive HCV infection (defined as undetectable HCV RNA)
ma8) History of or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, or
variceal bleeding).
9) Treatment < 3 months prior to screening or anticipated treatment during the study period with
immunosuppressant therapies, hydroxyurea, foscarnet, radiation, or cytotoxic
chemotherapeutic agents without approval from sponsor prior to randomization. Agents
disallowed in Section 5.3 may not be considered for sponsor approval.
10) Active malignancy requiring acute systemic therapy.
11) Abnormal electrocardiogram (ECG) at the screening visit that is clinically significant as
determined by the investigator.y be enrolled.
12) Any of the following laboratory values at screening:
a) CLcr ≤ 30 mL/min according to the Cockcroft-Gault formula {Cockcroft 1976}
b) Alanine aminotransferase > 5 upper limit of normal (ULN)
c) Direct bilirubin > 1.5 ULN
d) Platelets < 50,000/μL
e) Hemoglobin < 8.0 g/dL
13) Participation or planned participation in any other clinical study (including observational
studies) without prior approval from the sponsor.
14) Known hypersensitivity to any of the study drugs, their metabolites, or formulation
excipients.
15) Any other clinical condition or prior therapy that, in the opinion of the investigator, would
make the participant unsuitable for the study or unable to comply with dosing requirements.
16) Participants of childbearing potential (as defined in Appendix 11.5) who have a positive
serum pregnancy test at screening or positive urine and serum pregnancy tests at Day 1 prior
to study drug administration.
17) Participants who plan to continue breastfeeding during the study.
18) Requirement for ongoing therapy or use of any prohibited medications listed in Section 5.3
within 30 days prior to screening through the last dose of study drug.
study:
1) Participants 18 years of age or older at screening and able to understand and give written
informed consent.
2) HIV-1 RNA < 50 copies/mL for ≥ 6 months before screening, as documented by:
a) One HIV-1 RNA < 50 copies/mL immediately preceding the 24 week period prior to
screening.
b) Within 24 weeks prior to screening, if HIV-1 RNA results are available, all levels must
be < 50 copies/mL.
c) During the 6 to 12 months period prior to screening, transient detectable viremia
≥ 50 copies/mL is acceptable (“blip”), as long as it is not confirmed on 2 consecutive
visits.
3) Plasma HIV-1 RNA levels < 50 copies/mL at screening.
4) Participants are receiving B/F/TAF for ≥ 6 months prior to screening and willing to continue
until Day 1.
5) Participants assigned female at birth and of childbearing potential who engage in
heterosexual intercourse must agree to use protocol-specified methods of contraception as
described in Appendix 11.5.
Participants who meet any of the following exclusion criteria are not eligible to be enrolled in
this study:
1) Prior virologic failure.
2) Prior use of, or exposure to, ISL or LEN.
3) Active, serious infections requiring parenteral therapy within 30 days before randomization.
4) Active tuberculosis infection.
5) Acute hepatitis within 30 days before randomization.
6) HBV infection, as determined below at the screening visit:
a) Positive HBV surface antigen.
OR
b) Positive HBV core antibody and negative HBV surface antibody.
Note: participants found to be susceptible to HBV infection (eg, negative hepatitis B surface
antibody at the screening visit, regardless of prior HBV vaccination history) should be
recommended to receive HBV vaccination.
7) Active hepatitis C virus (HCV) coinfection, defined as detectable HCV RNA.
Note: participants with prior/inactive HCV infection (defined as undetectable HCV RNA)
ma8) History of or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, or
variceal bleeding).
9) Treatment < 3 months prior to screening or anticipated treatment during the study period with
immunosuppressant therapies, hydroxyurea, foscarnet, radiation, or cytotoxic
chemotherapeutic agents without approval from sponsor prior to randomization. Agents
disallowed in Section 5.3 may not be considered for sponsor approval.
10) Active malignancy requiring acute systemic therapy.
11) Abnormal electrocardiogram (ECG) at the screening visit that is clinically significant as
determined by the investigator.y be enrolled.
12) Any of the following laboratory values at screening:
a) CLcr ≤ 30 mL/min according to the Cockcroft-Gault formula {Cockcroft 1976}
b) Alanine aminotransferase > 5 upper limit of normal (ULN)
c) Direct bilirubin > 1.5 ULN
d) Platelets < 50,000/μL
e) Hemoglobin < 8.0 g/dL
13) Participation or planned participation in any other clinical study (including observational
studies) without prior approval from the sponsor.
14) Known hypersensitivity to any of the study drugs, their metabolites, or formulation
excipients.
15) Any other clinical condition or prior therapy that, in the opinion of the investigator, would
make the participant unsuitable for the study or unable to comply with dosing requirements.
16) Participants of childbearing potential (as defined in Appendix 11.5) who have a positive
serum pregnancy test at screening or positive urine and serum pregnancy tests at Day 1 prior
to study drug administration.
17) Participants who plan to continue breastfeeding during the study.
18) Requirement for ongoing therapy or use of any prohibited medications listed in Section 5.3
within 30 days prior to screening through the last dose of study drug.
試驗計畫預計收納受試者人數
-
台灣人數
35 人
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全球人數
600 人
