A Phase 3b, multi-center, randomized, parallel-group, open-label, non-inferiority study evaluating the efficacy, safety, and tolerability of oral dolutegravir/lamivudine once-daily as a first-line regimen compared to oral bictegravir/emtricitabine/tenofovir alafenamide once daily for virologic suppression and maintenance in antiretroviral therapy naive adults living with HIV

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-504993-40-00

Acronym

219816

Enrollment

378

Registered

2024-01-22

Start date

2024-02-14

Completion date

Unknown

Last updated

2025-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human immunodeficiency virus (HIV)

Brief summary

Participant with plasma HIV-RNA <50 copies/mL as per Snapshot algorithm at Week 48

Detailed description

Participant with plasma HIV-1 RNA <50 c/mL (c/mL) at Weeks 96 as per the Snapshot algorithm, - Participant with HIV-RNA >/= 50 c/mL as per Snapshot algorithm at Week 48, and Week 96, - Change from Baseline in HIV-1 RNA (log10 c/mL) and CD4+ cell count and CD4/CD8 ratio over time through Week 48 and Week 96., - Occurrence of disease progression (HIVassociated conditionsAIDS and death) through Week 48 and Week 96.

Interventions

DRUGDovato 50 mg/300 mg film-coated tablets

DRUGBiktarvy 50 mg/200 mg/25 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Participant with plasma HIV-RNA <50 copies/mL as per Snapshot algorithm at Week 48	—

Secondary

Measure	Time frame
Participant with plasma HIV-1 RNA <50 c/mL (c/mL) at Weeks 96 as per the Snapshot algorithm, - Participant with HIV-RNA >/= 50 c/mL as per Snapshot algorithm at Week 48, and Week 96, - Change from Baseline in HIV-1 RNA (log10 c/mL) and CD4+ cell count and CD4/CD8 ratio over time through Week 48 and Week 96., - Occurrence of disease progression (HIVassociated conditionsAIDS and death) through Week 48 and Week 96.	—

Measure

Time frame

—

Countries

Belgium, Denmark, France, Germany, Greece, Ireland, Italy, Poland, Portugal, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026