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Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1 ( ISLEND-2 )
EU CTIS ID: 2024-514047-28-00
What this study is testing
To evaluate the efficacy of switching to oral weekly islatravir (ISL; MK-8591)/lenacapavir (LEN; GS-6207) tablet regimen versus continuing standard of care in virologically suppressed people with HIV (PWH) at Week 48.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participants 18 years of age or older at screening and able to understand and give written informed consent.
- 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.
- Plasma HIV-1 RNA levels < 50 copies/mL at screening.
- Are receiving guideline-recommended standard of care treatment such as International Antiviral Society (IAS), Department of Health and Human Services (DHHS), European AIDS Clinical Society (EACS) 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 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 and single tablet regimen. TXF = TAF or TDF. Boosted PI taken once daily with cobicistat or ritonavir.
- 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.
You likely can't join if
- Prior virologic failure.
- 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
- Active hepatitis C virus (HCV) coinfection, defined as detectable HCV RNA. Note: particpants with prior/inactive HCV infection (defined as undetectable HCV RNA) may be enrolled.
- Any of the following laboratory values at screening: 1. Creatinine clearance (CLcr) ≤ 30 mL/min according to the Cockcroft-Gault formula 2. Alanine aminotransferase (ALT) > 5 x upper limit of normal (ULN) 3. Direct bilirubin > 1.5 x ULN 4. Platelets < 50,000/μL 5. Hemoglobin < 8.0 g/dL
- Participation or planned participation in any other clinical study (including observational studies) without prior approval from the sponsor.
- Known hypersensitivity to any of the study drugs, their metabolites, or formulation excipients.
See the full eligibility criteria
Who can join
- Participants 18 years of age or older at screening and able to understand and give written informed consent.
- 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.
- Plasma HIV-1 RNA levels < 50 copies/mL at screening.
- Are receiving guideline-recommended standard of care treatment such as International Antiviral Society (IAS), Department of Health and Human Services (DHHS), European AIDS Clinical Society (EACS) 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 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 and single tablet regimen. TXF = TAF or TDF. Boosted PI taken once daily with cobicistat or ritonavir.
- 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.
What rules you out
- Prior virologic failure.
- 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
- Active hepatitis C virus (HCV) coinfection, defined as detectable HCV RNA. Note: particpants with prior/inactive HCV infection (defined as undetectable HCV RNA) may be enrolled.
- Any of the following laboratory values at screening: 1. Creatinine clearance (CLcr) ≤ 30 mL/min according to the Cockcroft-Gault formula 2. Alanine aminotransferase (ALT) > 5 x upper limit of normal (ULN) 3. Direct bilirubin > 1.5 x ULN 4. Platelets < 50,000/μL 5. Hemoglobin < 8.0 g/dL
- Participation or planned participation in any other clinical study (including observational studies) without prior approval from the sponsor.
- Known hypersensitivity to any of the study drugs, their metabolites, or formulation excipients.
- 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.
- 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.
- Participants who plan to continue breastfeeding during the study.
- 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.
- History of or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, or variceal bleeding).
- Active malignancy requiring acute systemic therapy.
- Abnormal electrocardiogram (ECG) at the screening visit that is clinically significant as determined by the investigator.
- 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. (See Appendix 11.8.2 for United Kingdom [UK]-specific requirements for this criterion).
- Prior use of, or exposure to, ISL or LEN.
- Active, serious infections requiring parenteral therapy within 30 days before randomization.
- Active tuberculosis infection.
- Acute hepatitis within 30 days before randomization.
The study team makes the final eligibility decision.
Where it's taking place
- Puerto Rico
- Switzerland
- United Kingdom
- South Africa
- United States
- Argentina
- Thailand
- Taiwan
- Japan
- Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Puerto Rico; Switzerland; United Kingdom; South Africa; United States; Argentina and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.