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Virus Therapy

Islatravir + Lenacapavir for HIV (ISLEND-1 Trial)

Phase 3

Recruiting

Research Sponsored by Gilead Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* Individuals are receiving B/F/TAF for ≥ 6 months prior to screening and willing to continue until Day 1.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial aims to study the safety and effectiveness of switching to a once weekly tablet of islatravir/lenacapavir (ISL/LEN) compared to staying on the standard

Who is the study for?

This trial is for people with HIV who have had low virus levels (<50 copies/mL) for at least 6 months while on B/F/TAF treatment. They must be willing to continue their current treatment until the start of the study and, if they can become pregnant, agree to use certain birth control methods.

What is being tested?

The study compares a once-weekly oral tablet regimen of islatravir/lenacapavir (ISL/LEN) against continuing the standard daily bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF). The main goal is to see if switching treatments maintains low HIV levels after 48 weeks.

What are the potential side effects?

Potential side effects are not listed in the provided information. However, common side effects for antiretroviral drugs include nausea, diarrhea, headaches, fatigue and sometimes more serious effects like liver or kidney problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been on B/F/TAF for at least 6 months and can continue it.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Open- Label Extension (OLE) PhaseExperimental Treatment1 Intervention

After the end of Blinded Phase at Week 96, if safety and efficacy of ISL/LEN are demonstrated following review of unblinded data, all participants will be given an option to enter the open-label extension phase to receive ISL/LEN in an extension phase until ISL/LEN becomes available or until the sponsor elects to discontinue the study, whichever occurs first. Participants receiving ISL/LEN and PTM B/F/TAF during the blinded phase will continue to take ISL/LEN weekly. Participants receiving B/F/TAF and PTM ISL/LEN during the blinded phase will take an initial dose of ISL/LEN (Dose A), followed by once weekly ISL/LEN (Dose B) from Day 8 onwards.

Group II: Blinded Phase: PTM ISL/LEN + B/F/TAFExperimental Treatment2 Interventions

Participants will receive an initial dose of PTM ISL/LEN (Dose A), followed by once weekly PTM ISL/LEN (Dose B) from Day 8 onwards up to Week 96. Participants will also receive B/F/TAF (50/200/25 mg) once daily up from Day 1 up to Week 96.

Group III: Blinded Phase: ISL/LEN + Placebo-to-Match (PTM) B/F/TAFExperimental Treatment2 Interventions

Participants will receive an initial dose of ISL/LEN (Dose A), followed by once weekly ISL/LEN (Dose B) from Day 8 onwards up to Week 96. Participants will also receive PTM B/F/TAF once daily from Day 1 up to Week 96.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

B/F/TAF

2016

Completed Phase 4

~5170

0 / 1Eligibility criteria met