Study of an Injectable Regimen of GS-3242 With Lenacapavir Compared to Biktarvy in People New to HIV-1 Treatment

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NCT07708727 · readout ≤ 1,534 d

Sponsored by Gilead Sciences (industry) · GILD — their whole pipeline →.

Phase

Phase 2/3

Status

Recruiting

Study type

Interventional

Design

Randomized · None · Treatment

Enrollment

700estimated

Sites

Countries

Puerto Rico, United States

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2026-07-29

actual

When the study began enrolling

Primary completion

Oct 2030

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

Apr 2033

estimated

The whole study's end, after follow-up

First posted

2026-07-16

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-08-14

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

HIV-1-infection

Interventions

Drug: GS-3242 Tablet
Drug: GS-3242 Injection
Drug: Lenacapavir Tablet — also filed as LEN
Drug: Lenacapavir Injection — also filed as LEN
Drug: B/F/TAF — also filed as Biktarvy

Primary outcomes

what the primary-completion date above is the date OF

Phase 2: Part A: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 35 as Determined by the United States (US) Food and Drug Administration (FDA) Snapshot Algorithm

measured Week 35

Phase 2: Part B: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 26 as Determined by the US FDA Snapshot Algorithm

measured Week 26

Phase 3: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 52 as Determined by the US FDA Snapshot Algorithm

measured Week 52

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