A Phase 3b, multicenter, single-arm, open-label study evaluating the efficacy, safety, and tolerability of switching to DTG/3TC single tablet regimen administered once daily from a bictegravir/emtricitabine/tenofovir alafenamide single tablet regimen in people living with HIV of at least 50 years of age who are virologically suppressed

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-503137-66-00

Acronym

219516

Enrollment

117

Registered

2023-11-10

Start date

2023-11-29

Completion date

Unknown

Last updated

2025-11-23

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

Participants with plasma HIV-1 RNA ≥ 50 copies/mL (Snapshot algorithm) at Week 48

Detailed description

Participants with plasma HIV-1 RNA ≥ 50 copies/mL (Snapshot algorithm) at 24 and 96 weeks Participants with plasma HIV-1 RNA <50 copies/mL (Snapshot algorithm) at 24, 48 and 96 weeks Absolute values and changes from baseline in CD4+ cells count and CD4:CD8 ratio at 24, 48 and 96 weeks Occurrence of disease progression (HIV associated conditions, AIDS, and death) through Weeks 24, 48 and 96., Occurrence of viral resistance in participants meeting confirmed virologic withdrawal criterion over time, Occurrence of DTG/3TC-non-Serious Adverse drug-related reactions, all SAEs and proportion of participants who discontinue treatment due to AEs

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
Participants with plasma HIV-1 RNA ≥ 50 copies/mL (Snapshot algorithm) at Week 48	—

Secondary

Measure	Time frame
Participants with plasma HIV-1 RNA ≥ 50 copies/mL (Snapshot algorithm) at 24 and 96 weeks Participants with plasma HIV-1 RNA <50 copies/mL (Snapshot algorithm) at 24, 48 and 96 weeks Absolute values and changes from baseline in CD4+ cells count and CD4:CD8 ratio at 24, 48 and 96 weeks Occurrence of disease progression (HIV associated conditions, AIDS, and death) through Weeks 24, 48 and 96., Occurrence of viral resistance in participants meeting confirmed virologic withdrawal criterion over time, Occurrence of DTG/3TC-non-Serious Adverse drug-related reactions, all SAEs and proportion of participants who discontinue treatment due to AEs	—

Measure

Time frame

—

Countries

Austria, Belgium, France, Germany, Italy, Netherlands, Portugal, Spain

Outcome results

None listed

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