台灣臨床試驗主持人資料庫|TPIDB

Condition/Disease

Virologically suppressed individuals with HIV-1 infection receiving standard therapy.

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 standard therapy 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 standard therapy 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

Islatravir/Lenacapavir

Active Ingredient

Islatravir/Lenacapavir

Dosage Form

116

Dosage

0.5/300 mg

Endpoints

• Proportion of participants with HIV-1 RNA ≥50 copies/mL at Week 48, as determined by the U.S. Food and Drug Administration (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 weeks 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) Are receiving a guideline-recommended standard of care oral therapy (per guidelines such as
IAS, DHHS, EACS) listed below consisting of 2 or 3 ARVs for ≥ 6 months prior to
screening and willing to continue until Day 1. Participants in Treatment Group 2 must also be
willing to continue their standard of care until the end of randomized treatment visit (through
at least Week 96).
a) INSTI combined with 1 or 2 NRTIs (B/F/TAF, DTG/ABC/3TC, DTG+TXF/FTC,
DTG/TDF/3TC, DTG/3TC, RAL+TXF/FTC, RAL+TDF/3TC, EVG/c/TXF/FTC), or
b) Boosted PI combined with 2 NRTIs (D/C/F/TAF, boosted DRV+TXF/FTC, boosted
DRV+TDF/3TC), or
c) NNRTI combined with 2 NRTIs (DOR/TDF/3TC, DOR+TXF/FTC, DOR+TDF/3TC,
RPV/TXF/FTC, RPV+TXF/FTC, RPV+TDF/3TC).
Notes: RAL can be taken either once or twice daily; all other agents are to be taken once
daily, including FDC and single tablet regimen. TXF = TAF. Boosted PI taken once daily
with cobicistat or ritonavir.
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) may be
enrolled.
8) 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.
12) Any of the following laboratory values at screening:
a) Creatinine clearance (CLcr) ≤ 30 mL/min according to the Cockcroft-Gault formula
{Cockcroft 1976}
b) Alanine aminotransferase (ALT) > 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.

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 weeks 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) Are receiving a guideline-recommended standard of care oral therapy (per guidelines such as
IAS, DHHS, EACS) listed below consisting of 2 or 3 ARVs for ≥ 6 months prior to
screening and willing to continue until Day 1. Participants in Treatment Group 2 must also be
willing to continue their standard of care until the end of randomized treatment visit (through
at least Week 96).
a) INSTI combined with 1 or 2 NRTIs (B/F/TAF, DTG/ABC/3TC, DTG+TXF/FTC,
DTG/TDF/3TC, DTG/3TC, RAL+TXF/FTC, RAL+TDF/3TC, EVG/c/TXF/FTC), or
b) Boosted PI combined with 2 NRTIs (D/C/F/TAF, boosted DRV+TXF/FTC, boosted
DRV+TDF/3TC), or
c) NNRTI combined with 2 NRTIs (DOR/TDF/3TC, DOR+TXF/FTC, DOR+TDF/3TC,
RPV/TXF/FTC, RPV+TXF/FTC, RPV+TDF/3TC).
Notes: RAL can be taken either once or twice daily; all other agents are to be taken once
daily, including FDC and single tablet regimen. TXF = TAF. Boosted PI taken once daily
with cobicistat or ritonavir.
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) may be
enrolled.
8) 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.
12) Any of the following laboratory values at screening:
a) Creatinine clearance (CLcr) ≤ 30 mL/min according to the Cockcroft-Gault formula
{Cockcroft 1976}
b) Alanine aminotransferase (ALT) > 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.

Clinical Trials List

A Phase 3, Randomized, Open-Label, Active-Controlled Study to Evaluate a Switch to an Oral Weekly Islatravir/Lenacapavir Regimen in People With HIV-1 Who Are Virologically Suppressed on Standard of Care

Investigators and Locations