At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 203 enrolled
Drug / intervention
DTG/3TCdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating DTG/3TC for HIV and HIV Infections. Completed, enrolled 203 participants across 56 sites in 12 countries.
Detailed Summary
The study aims at evaluating the maintenance of virologic suppression of dolutegravir/lamivudine (DTG/3TC) fixed dose combination (FDC) at Week 48 post-switch from bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in participants living with Human Immunodeficiency Virus Type 1 (HIV-1) who are of at least 50 years of age and above.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV, HIV Infections
CountriesAustria, Belgium, Canada, France, Germany, Italy, Mexico, Netherlands, Portugal, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
202420252026
First PostedJun 2023
Enrollment StartJul 2023
Primary CompletionJan 2026
Study CompletionFeb 2026
TodayJul 2026
First PostedJun 22, 2023
Enrollment StartJul 27, 2023
Primary CompletionJan 23, 2026
Study CompletionFeb 9, 2026
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 3.0 years ago
Interventions
DTG/3TCdrug
DTG/3TC FDC will be administered once daily.