Phase 3
Completed N=205
A Study to Evaluate Efficacy, Safety and Tolerability in Antiretroviral Therapy (ART)-Experienced Participants of at Least 50 Years of Age Living With Human Immunodeficiency Virus (HIV) With Virologic Suppression Who Switch to DTG/3TC FDC From BIC/FTC/TAF
Source: ClinicalTrials.gov NCT05911360 ↗Enrolled (actual)
205
Serious AEs
12.7%
Results posted
May 2026
Primary outcomePrimary: Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Greater Than or Equal to (>=)50 Copies/Millilitre (c/mL) at Week 48 — 2 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Greater Than or Equal to (>=)50 Copies/Millilitre (c/mL) at Week 48 |
2 | — |
| SECONDARY Number of Participants With Plasma HIV-1 RNA >= 50 c/mL at Week 24 |
14 | — |
| SECONDARY Number of Participants With Plasma HIV-1 RNA >= 50 c/mL at Week 96 |
— | — |
| SECONDARY Number of Participants With Plasma HIV-1 RNA Less Than (<) 50 c/mL at Week 24 |
183; 8 | — |
| SECONDARY Number of Participants With Plasma HIV-1 RNA < 50 c/mL at Week 48 |
177; 26 | — |
| SECONDARY Number of Participants With Plasma HIV-1 RNA < 50 c/mL at Week 96 |
— | — |
| SECONDARY Absolute Values for Cluster of Differentiation 4 (CD4+) Cells Count at Week 24 |
724.8 | — |
| SECONDARY Absolute Values for CD4+ Cells Count at Week 48 |
723.6 | — |
| SECONDARY Absolute Values for CD4+ Cells Count at Week 96 |
— | — |
| SECONDARY Absolute Values for CD4: Cluster of Differentiation 8 (CD8) Ratio at Week 24 |
1.127 | — |
| SECONDARY Absolute Values for CD4:CD8 Ratio at Week 48 |
1.210 | — |
| SECONDARY Absolute Values for CD4:CD8 Ratio at Week 96 |
— | — |
| SECONDARY Change From Baseline in CD4+ Cells Count at Week 24 |
733.6; -8.9 | — |
| SECONDARY Change From Baseline in CD4+ Cells Count at Week 48 |
733.6; -16.8 | — |
| SECONDARY Change From Baseline in CD4+ Cells Count at Week 96 |
— | — |
| SECONDARY Change From Baseline in CD4:CD8 Ratio at Week 24 |
1.167; -0.027 | — |
| SECONDARY Change From Baseline in CD4:CD8 Ratio at Week 48 |
1.167; 0.030 | — |
| SECONDARY Change From Baseline in CD4:CD8 Ratio at Week 96 |
— | — |
| SECONDARY Number of Participants With Disease Progression (HIV-associated Conditions, AIDS, and Death) Through Week 24 |
4 | — |
| SECONDARY Number of Participants With Disease Progression (HIV-associated Conditions, AIDS, and Death) Through Week 48 |
6 | — |
| SECONDARY Number of Participants With Disease Progression (HIV-associated Conditions, AIDS, and Death) Through Week 96 |
— | — |
| SECONDARY Number of Participants With Viral Resistance After Meeting Confirmed Virologic Withdrawal (CVW) Criterion |
— | — |
| SECONDARY Number of Participants With Viral Resistance After Meeting CVW Criterion |
— | — |
| SECONDARY Number of Participants With Treatment Related Non-serious Adverse Events (AEs) |
17 | — |
| SECONDARY Number of Participants With Treatment Related Non-serious AEs |
— | — |
| SECONDARY Number of Participants With Any Serious Adverse Events (SAEs) |
26 | — |
| SECONDARY Number of Participants With SAEs |
— | — |
| SECONDARY Number of Participants With AEs Leading to Treatment Discontinuation |
— | — |
Eligibility Criteria
Inclusion Criteria
- Participants living with HIV-1 with documented plasma HIV-1 RNA ]35 percentage [%] direct bilirubin).
- Participant has estimated creatine clearance <30 millilitres per minute (mL/min) per 1.73 square meter (m^2) using the refitted, race-neutral Chronic Kidney Disease Epidemiology Collaboration (CKD-EPIcr\_R) method.
Data sourced from ClinicalTrials.gov (NCT05911360). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.