A Phase 3, Randomized, Open-Label, Active-Controlled Study toEvaluate a Switch to an Oral Weekly Islatravir/Lenacapavir Regimen in People With HIV-1 Who Are Virologically Suppressed on Standard of Care
Samir Gupta, MD
Primary Investigator
Brief description of study
- To evaluate the efficacy of switching to oral weekly ISL/LEN FDC tablet regimen versus continuing standard of care in virologically suppressed PWH at Week 48</li>
- To evaluate the efficacy of switching to oral weekly ISL/LEN FDC in virologically suppressed PWH at Weeks 48 and 96</li>
- To evaluate the safety and tolerability of oral weekly ISL/LEN FDC
Study Population: PWH (≥ 18 years of age) who are on standard of care and have been
virologically suppressed for at least 6 months prior to screening.
Detailed description of study
What will happen during the study?
Participants who provide written consent and meet all eligibility criteria will be randomized in a
1:1 ratio to 1 of the following 2 treatment groups:
Treatment Group 1:
• Loading doses of ISL/LEN 0.5/300 mg FDC tablets on Days 1 and 2<br>• Maintenance dose of ISL/LEN 2/300 mg FDC tablets administered orally, once weekly from
Day 8 onwards, without regard to food (n = 300).
Treatment Group 2: continue guideline-recommended standard of care oral daily therapy (per
guidelines such as International Antiviral Society [IAS], Department of Health and Human
Services [DHHS], and European AIDS Clinical Society [EACS]) consisting of 2 or 3 ARVs
(n = 300). This includes people receiving:
• Integrase strand-transfer inhibitor (INSTI) combined with 1 or 2 nucleoside reverse
transcriptase inhibitors (NRTIs; bictegravir/emtricitabine/tenofovir alafenamide [B/F/TAF;
coformulated; Biktarvy®], dolutegravir [DTG]/abacavir [ABC]/lamivudine [3TC],
DTG+TXF/emtricitabine [FTC; Emtriva®], DTG/tenofovir disoproxil fumarate [TDF;
Viread®]/3TC, DTG/3TC, raltegravir [RAL] + TXF/FTC, RAL+TDF/3TC, elvitegravir
[EVG; Vitekta®]/cobicistat [c; Tybost®]/TXF/FTC), or
• Boosted protease inhibitor (PI) combined with 2 NRTIs
(darunavir/cobicistat/emtricitabine/tenofovir alafenamide [D/C/F/TAF; coformulated],
boosted darunavir (DRV)+TXF/FTC, boosted DRV+TDF/3TC), or
• Nonnucleoside reverse transcriptase inhibitor (NNRTI) combined with 2 NRTIs ([doravirine]
DOR/TDF/3TC, DOR+TXF/FTC, DOR+TDF/3TC, rilpivirine [RPV]/TXF/FTC,
RPV+TXF/FTC, RPV+TDF/3TC).
• NOTE: 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 = tenofovir alafenamide (TAF;
Vemlidy®) or TDF. Boosted PI taken once daily with cobicistat or ritonavir.
Investigators must ensure to provide a prescription for standard of care medications to
participants in Treatment Group 2. Participants in Treatment Group 2 are responsible for
obtaining their standard of care medications.
Extension Phase
After Week 96, all participants will continue to take their randomized study drug and attend
visits every 12 weeks until the end of randomized treatment visit. Once the last participant
completes the Week 96 visit and the sponsor completes the Week 96 analysis, all participants
will return to the clinic (preferable within 30 days) for an end of randomized treatment visit. At
the end of randomized treatment visit, if safety and efficacy of ISL/LEN FDC are demonstrated
following review of randomized data, participants will be given the option to receive
ISL/LEN FDC in an extension phase until ISL/LEN FDC becomes available, or until the sponsor
elects to discontinue the study, whichever occurs first. Participants who opt out of receiving
ISL/LEN FDC in the extension phase will discontinue the study
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: HIV-1
-
Age: 18 years - 100 years
-
Gender: All
Inclusion Criteria:
• ≥ 18 years of age at screening.
• Documented plasma HIV-1 RNA < 50 copies/mL for ≥ 6 months before and at screening.
• Are receiving guideline-recommended standard of care oral therapy (per guidelines such as
IAS, DHHS, 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.
• No prior use of, or exposure to, ISL or LEN.
• No prior virologic failure.
• No Hepatitis B virus infection.
