Clinical Trials List
Protocol NumberGS-US-5635925
Active
2025-01-01 - 2031-01-26
Phase III
Recruiting5
A Phase 3, Randomized, Double-blind, Active-controlled Study to Evaluate a Switch to an Oral Weekly Islatravir/Lenacapavir Regimen in People With HIV-1 Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir (B/F/TAF)
-
Trial Applicant
GILEAD SCIENCES HONG KONG LIMITED
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Sponsor
Gilead Sciences HK Ltd. Taiwan Branch
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- CHIEN-YU CHENG 無
- 陳正斌 無
- 李淑媛 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Po-Liang Lu
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Virologically suppressed HIV-1–infected individuals receiving bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF).
Objectives
Primary Objective
• To evaluate the efficacy of switching to a once-weekly oral fixed-dose combination (FDC) of islatravir (ISL; MK-8591) and lenacapavir (LEN; GS-6207) compared with continuing bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in virologically suppressed people with HIV-1 (PWH) at Week 48.
Secondary Objectives
• To evaluate the efficacy of switching to a once-weekly oral ISL/LEN FDC compared with continuing B/F/TAF in virologically suppressed PWH at Weeks 48 and 96.
• To evaluate the safety and tolerability of the once-weekly oral ISL/LEN FDC regimen.
Test Drug
EMTRICITABINE
Lenacapavir Sodium
Lenacapavir Sodium
Active Ingredient
EMTRICITABINE
Lenacapavir Sodium
Lenacapavir Sodium
Dosage Form
116
116
116
Dosage
200 mg
300 mg
300 mg
Endpoints
Proportion of participants with HIV-1 RNA ≥50 copies/mL at Week 48, as determined by the U.S. FDA–defined Snapshot algorithm.
Inclution Criteria
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.
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.
Exclusion Criteria
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.
The Estimated Number of Participants
-
Taiwan
35 participants
-
Global
600 participants
