Islatravir + Lenacapavir for HIV

Recruiting in Palo Alto (17 mi)

+47 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Gilead Sciences

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests the effectiveness of taking two medications, islatravir and lenacapavir, regularly for people with HIV who already have very low virus levels. The goal is to see if this combination keeps the virus under control over several months.

Research Team

Gilead Study Director

Principal Investigator

Gilead Sciences

Eligibility Criteria

This trial is for people with HIV who have maintained a viral load of less than 50 copies/mL and have been on B/F/TAF treatment for at least 24 weeks. They shouldn't have had previous virologic failures, exposure to ISL or LEN, serious infections within the last month, hepatitis B or C co-infections, low kidney function or certain low blood cell counts.

Inclusion Criteria

Plasma HIV-1 RNA < 50 copies/mL at screening

My HIV-1 levels have been undetectable or very low for at least 24 weeks.

I have been on B/F/TAF medication for at least 24 weeks.

Exclusion Criteria

CD4+ T-cells < 200 cells/mm^3 (Cohort 1); CD4+ T-cells < 350 cells/mm^3 (cohort 2)

I have previously used or been exposed to islatravir or lenacapavir.

My kidney function is low, with a creatinine clearance of 30 mL/min or less.

See 8 more

Treatment Details

Interventions

B/F/TAF (Antiretroviral Combination)
Islatravir (Nucleoside Reverse Transcriptase Inhibitor)
Lenacapavir (Integrase Strand Transfer Inhibitor)

Trial OverviewThe study tests the effectiveness of taking Islatravir (ISL) orally once a week combined with Lenacapavir (LEN) in those whose HIV is already under control. The goal is to see how well this combination works after 24 weeks compared to their current treatment.

Participant Groups

4Treatment groups

Experimental Treatment

Group I: Cohort 2 (ISL+LEN)Experimental Treatment2 Interventions

Participants will receive the following for at least 48 weeks * Day 1: LEN oral 600 mg (2 x 300 mg) and ISL 2 mg (2 x 1 mg) * Day 2: LEN only oral 600 mg (2 x 300 mg) * Day 8 and weekly thereafter (ie, every 7 days): LEN oral 300 mg (1 x 300 mg) and ISL 2 mg

Group II: Cohort 2 (B/F/TAF to ISL+LEN)Experimental Treatment3 Interventions

Participants will receive B/F/TAF 50/200/25 mg once daily for at least 48 weeks After 48 weeks, participants will switch from B/F/TAF to ISL+LEN * Day 1: LEN oral 600 mg (2 x 300 mg) and ISL 2 mg (2 x 1 mg) * Day 2: LEN only oral 600 mg (2 x 300 mg) * Day 8 and weekly thereafter (ie, every 7 days): LEN oral 300 mg (1 x 300 mg) and ISL 2 mg Participants who do not switch from B/F/TAF to ISL+LEN at Week 48 will be discontinued from the study.

Group III: Cohort 1 (ISL+LEN)Experimental Treatment2 Interventions

Participants will receive the following for at least 48 weeks: * Day 1 and Day 2: ISL 40 and LEN 600 mg * Day 8 and weekly thereafter (ie, every 7 days): ISL 20 mg and LEN 300 mg

Group IV: Cohort 1 (B/F/TAF to ISL+LEN)Experimental Treatment3 Interventions

Participants will receive bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) 50/200/25 mg once daily for at least 48 weeks After 48 weeks, participants will switch from B/F/TAF to ISL+LEN * ISL 40 and LEN 600 mg on Day 1 and Day 2 * ISL 20 mg and LEN 300 mg weekly Participants who do not switch from B/F/TAF to ISL+LEN at Week 48 will be discontinued from the study.