NCT04493216 (DOMINO) is a Phase 2 clinical trial of GSK3640254 in HIV Infections, sponsored by ViiV Healthcare.

Who is sponsoring NCT04493216?

NCT04493216 is sponsored by ViiV Healthcare.

What drugs are being tested in NCT04493216?

Interventions in NCT04493216: GSK3640254, ABC/3TC, FTC/TAF, Dolutegravir, Placebo.

What condition does NCT04493216 study?

NCT04493216 studies HIV Infections.

Is NCT04493216 still recruiting?

NCT04493216 is currently terminated. Last updated 26 June 2024.

Are results published for NCT04493216?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-06-26 · How we verify

NCT04493216: DOMINO

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Dose-Range Finding Clinical Trial Study in Human Immunodeficiency Virus (HIV-1) Infected Treatment-Naive Adults

Terminated Phase 2 Results posted Last updated 26 June 2024

What this trial tests

Phase 2 trial testing GSK3640254 in HIV Infections in 161 participants. Terminated before completion.

Timeline

18 November 2020

Primary endpoint
5 September 2022

29 May 2023

Quick facts

Lead sponsor	ViiV Healthcare
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	161
Start date	18 November 2020
Primary completion	5 September 2022
Estimated completion	29 May 2023
Sites	65 locations across France, Italy, South Africa, Russia, Germany, Argentina, Canada, Switzerland

Drugs / interventions tested

GSK3640254 — full drug profile →
ABC/3TC — full drug profile →
FTC/TAF — full drug profile →
Dolutegravir (DOLUTEGRAVIR) — full drug profile →
Placebo

Conditions studied

HIV Infections — all drugs for HIV Infections →

Sponsor

ViiV Healthcare — full company profile →

Who can join

18 and older, any sex, with HIV Infections. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<)50 Copies Per Milliliter (c/mL) at Week 24 Primary · At Week 24

Percentage of participants with plasma HIV-1 RNA \<50 c/mL at week 24 was assessed using the Food and Drug Administration (FDA) snapshot algorithm to demonstrate the antiviral activity of GSK3640254 given in combination with either ABC/3TC or FTC/TAF compared to the reference treatment of DTG given in combination with either ABC/3TC or FTC/TAF.

Group	Value	95% CI
GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF	82.5	68.1 – 91.3
GSK3640254 150 mg + ABC/3TC or FTC/TAF	90.7	78.4 – 96.3
GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF	76.2	61.5 – 86.5
Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF	91.7	78.2 – 97.1

Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 48 Secondary · At Week 48

Percentage of participants with plasma HIV-1 RNA \<50 c/mL at week 48 was assessed using the FDA snapshot algorithm to demonstrate the antiviral activity of GSK3640254 given in combination with either ABC/3TC or FTC/TAF compared to the reference treatment of DTG given in combination with either ABC/3TC or FTC/TAF.

Group	Value	95% CI
GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF	85.0	70.9 – 92.9
GSK3640254 150 mg + ABC/3TC or FTC/TAF	83.7	70.0 – 91.9
GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF	76.2	61.5 – 86.5
Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF	77.8	61.9 – 88.3

Absolute Values of HIV-1 RNA at Weeks 24 and 48 Secondary · Baseline (Day 1) and at Weeks 24 and 48

Plasma samples were collected for quantitative analysis of HIV-1 RNA. Logarithm to base 10 (log10) values for plasma HIV-1 RNA have been presented. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Baseline (Day 1)

Group	Value	95% CI
GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF	4.351	± 0.5712
GSK3640254 150 mg + ABC/3TC or FTC/TAF	4.353	± 0.6705
GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF	4.165	± 0.6505
Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF	4.247	± 0.6765

Week 24

Group	Value	95% CI
GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF	1.619	± 0.1260
GSK3640254 150 mg + ABC/3TC or FTC/TAF	1.607	± 0.0663
GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF	1.610	± 0.0679
Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF	1.592	± 0.0126

Week 48

Group	Value	95% CI
GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF	1.602	± 0.0536
GSK3640254 150 mg + ABC/3TC or FTC/TAF	1.605	± 0.0647
GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF	1.594	± 0.0233
Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF	1.590	± 0.0000

Change From Baseline in Plasma HIV-1 RNA at Weeks 24 and 48 Secondary · Baseline (Day 1) and at Weeks 24 and 48

Plasma samples were collected for quantitative analysis of HIV-1 RNA. log10 values for plasma HIV-1 RNA have been presented. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.

Baseline (Day 1)

Group	Value	95% CI
GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF	4.351	± 0.5712
GSK3640254 150 mg + ABC/3TC or FTC/TAF	4.353	± 0.6705
GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF	4.165	± 0.6505
Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF	4.247	± 0.6765

Change from Baseline to Week 24

Group	Value	95% CI
GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF	-2.718	± 0.5501
GSK3640254 150 mg + ABC/3TC or FTC/TAF	-2.784	± 0.6615
GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF	-2.565	± 0.6513
Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF	-2.629	± 0.6835

Change from Baseline to Week 48

Group	Value	95% CI
GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF	-2.675	± 0.5640
GSK3640254 150 mg + ABC/3TC or FTC/TAF	-2.762	± 0.6784
GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF	-2.580	± 0.6941
Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF	-2.717	± 0.6672

Absolute Values of Cluster of Differentiation 4 Plus (CD4+) Cell Counts at Weeks 24 and 48 Secondary · Baseline (Day 1) and at Weeks 24 and 48

Blood samples were collected and CD4+ cell count was assessed using flow cytometry. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Baseline (Day 1)

Group	Value	95% CI
GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF	480.3	± 171.72
GSK3640254 150 mg + ABC/3TC or FTC/TAF	509.7	± 207.13
GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF	478.7	± 204.04
Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF	514.1	± 240.88

Week 24

Group	Value	95% CI
GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF	717.5	± 222.91
GSK3640254 150 mg + ABC/3TC or FTC/TAF	643.5	± 202.27
GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF	689.8	± 316.64
Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF	724.8	± 403.99

Week 48

Group	Value	95% CI
GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF	749.9	± 328.28
GSK3640254 150 mg + ABC/3TC or FTC/TAF	702.6	± 258.65
GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF	747.3	± 313.15
Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF	705.2	± 221.18

Change From Baseline in CD4+ Cell Counts at Weeks 24 and 48 Secondary · Baseline (Day 1) and at Weeks 24 and 48

Baseline (Day 1)

Group	Value	95% CI
GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF	480.3	± 171.72
GSK3640254 150 mg + ABC/3TC or FTC/TAF	509.7	± 207.13
GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF	478.7	± 204.04
Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF	514.1	± 240.88

Change from Baseline to Week 24

Group	Value	95% CI
GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF	241.3	± 191.26
GSK3640254 150 mg + ABC/3TC or FTC/TAF	129.3	± 233.07
GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF	202.3	± 271.98
Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF	198.5	± 285.00

Change from Baseline to Week 48

Group	Value	95% CI
GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF	292.4	± 264.16
GSK3640254 150 mg + ABC/3TC or FTC/TAF	189.2	± 216.10
GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF	243.0	± 233.24
Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF	190.6	± 180.19

Number of Participants With Serious Adverse Events (SAEs) and Deaths Secondary · From Day 1 up to end of continued access to treatment post-study termination (Day 922)

An SAE was defined as any serious adverse event that, at any dose resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or any other situation according to medical or scientific judgment.

Serious Adverse Events

Group	Value	95% CI
GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF	2
GSK3640254 150 mg + ABC/3TC or FTC/TAF	7
GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF	2
Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF	2

Deaths

Group	Value	95% CI
GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF	0
GSK3640254 150 mg + ABC/3TC or FTC/TAF	0
GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF	0
Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF	0

Number of Participants With Adverse Events (AEs) Leading to Treatment Discontinuation Secondary · From Day 1 up to end of continued access to treatment post-study termination (Day 922)

Group	Value	95% CI
GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF	2
GSK3640254 150 mg + ABC/3TC or FTC/TAF	4
GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF	5
Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF	2

Number of Participants With AEs Based on Maximum Severity Grades Secondary · From Day 1 up to end of continued access to treatment post-study termination (Day 922)

An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. The severity of AEs was defined as per the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table) Version 2.1 and was categorized into grades as following: Grade 1 - mild, Grade 2 - moderate, Grade 3 - severe, Grade 4 - Potentially life threatening and Grade 5 - Fatal. Higher grade indicates more severe condition.

Grade 1

Group	Value	95% CI
GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF	12
GSK3640254 150 mg + ABC/3TC or FTC/TAF	14
GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF	17
Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF	15

Grade 2

Group	Value	95% CI
GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF	19
GSK3640254 150 mg + ABC/3TC or FTC/TAF	17
GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF	17
Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF	10

Grade 3

Group	Value	95% CI
GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF	5
GSK3640254 150 mg + ABC/3TC or FTC/TAF	5
GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF	3
Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF	3

Grade 4

Group	Value	95% CI
GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF	1
GSK3640254 150 mg + ABC/3TC or FTC/TAF	2
GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF	1
Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF	0

Grade 5

Group	Value	95% CI
GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF	0
GSK3640254 150 mg + ABC/3TC or FTC/TAF	0
GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF	0
Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF	0

Number of Participants With AEs of Special Interest (AESI) Secondary · From Day 1 up to end of continued access to treatment post-study termination (Day 922)

AESI (Gastrointestinal)

Group	Value	95% CI
GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF	15
GSK3640254 150 mg + ABC/3TC or FTC/TAF	18
GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF	14
Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF	14

AESI (Nervous system)

Group	Value	95% CI
GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF	7
GSK3640254 150 mg + ABC/3TC or FTC/TAF	5
GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF	7
Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF	3

AESI (Psychiatric)

Group	Value	95% CI
GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF	4
GSK3640254 150 mg + ABC/3TC or FTC/TAF	3
GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF	4
Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF	4

Number of Participants With Genotypic Resistance Secondary · Baseline (Day 1) and at Weeks 24 and 48

Plasma samples were collected for resistance testing. Genotypic testing was conducted in participants meeting protocol-defined virologic failure (PDVF) criteria. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Only those participants with data available at specified time points have been analyzed.

Baseline (Day 1)

Group	Value	95% CI
GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF	0
GSK3640254 150 mg + ABC/3TC or FTC/TAF	0
GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF	0
Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF	0

Weeks 24

Group	Value	95% CI
GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF	0
GSK3640254 150 mg + ABC/3TC or FTC/TAF	0
GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF	0
Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF	0

Weeks 48

Group	Value	95% CI
GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF	0
GSK3640254 150 mg + ABC/3TC or FTC/TAF	0
GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF	0
Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF	0

Number of Participants With Phenotypic Resistance Secondary · Baseline (Day 1) and at Weeks 24 and 48

Plasma samples were collected for resistance testing. Phenotypic testing was conducted in participants meeting PDVF criteria. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Baseline (Day 1)

Group	Value	95% CI
GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF	0
GSK3640254 150 mg + ABC/3TC or FTC/TAF	0
GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF	0
Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF	0

Weeks 24

Group	Value	95% CI
GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF	0
GSK3640254 150 mg + ABC/3TC or FTC/TAF	0
GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF	0
Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF	0

Weeks 48

Group	Value	95% CI
GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF	0
GSK3640254 150 mg + ABC/3TC or FTC/TAF	0
GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF	0
Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF	0

Adverse events — posted to ClinicalTrials.gov

Time frame: All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).. Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF

Serious: 2/40 (5%)

Deaths: 0/40

GSK3640254 150 mg + ABC/3TC or FTC/TAF

Serious: 7/43 (16%)

Deaths: 0/43

GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF

Serious: 2/42 (5%)

Deaths: 0/42

Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF

Serious: 2/36 (6%)

Deaths: 0/36

Serious adverse events (15 terms)

Reaction	System	GSK3640254 100 mg+ Placebo…	GSK3640254 150 mg + ABC/3T…	GSK3640254 200 mg+ Placebo…	Dolutegravir (DTG) 50 mg +…
Colitis	Gastrointestinal disorders	—	—	—	—
Pancreatitis	Gastrointestinal disorders	—	—	—	—
Cholecystitis acute	Hepatobiliary disorders	—	—	—	—
Appendicitis	Infections and infestations	—	—	—	—
Cellulitis	Infections and infestations	—	—	—	—
Necrotising fasciitis	Infections and infestations	—	—	—	—
Ankle fracture	Injury, poisoning and procedural complications	—	—	—	—
Limb fracture	Injury, poisoning and procedural complications	—	—	—	—
Anogenital warts	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	—	—	—	—
Substance dependence	Psychiatric disorders	—	—	—	—
Suicidal ideation	Psychiatric disorders	—	—	—	—
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Dermatitis allergic	Skin and subcutaneous tissue disorders	—	—	—	—

Other adverse events (32 terms — click to expand)

Reaction	System	GSK3640254 100 mg+ Placebo…	GSK3640254 150 mg + ABC/3T…	GSK3640254 200 mg+ Placebo…	Dolutegravir (DTG) 50 mg +…
COVID-19	Infections and infestations	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—
Headache	Nervous system disorders	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—
Syphilis	Infections and infestations	—	—	—	—
Pyrexia	General disorders	—	—	—	—
Influenza	Infections and infestations	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—
Pharyngitis	Infections and infestations	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—
Toothache	Gastrointestinal disorders	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—
Asthenia	General disorders	—	—	—	—
Respiratory tract infection	Infections and infestations	—	—	—	—
Blood creatine phosphokinase increased	Investigations	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—
Anxiety	Psychiatric disorders	—	—	—	—
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—
Food poisoning	Gastrointestinal disorders	—	—	—	—
Haemorrhoids	Gastrointestinal disorders	—	—	—	—
Chlamydial infection	Infections and infestations	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—
Gonorrhoea	Infections and infestations	—	—	—	—
Monkeypox	Infections and infestations	—	—	—	—
Urethritis	Infections and infestations	—	—	—	—
Limb injury	Injury, poisoning and procedural complications	—	—	—	—
Anogenital warts	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—

Most-reported serious reactions: Colitis, Pancreatitis, Cholecystitis acute, Appendicitis, Cellulitis, Necrotising fasciitis, Ankle fracture, Limb fracture.

Data from ClinicalTrials.gov NCT04493216 adverse events section.

Sponsor's own description

This is a phase 2b, randomized, multicenter, parallel group, partially blind (to GSK3640254 doses \[100, 150 and 200 milligrams {mg}\]), active controlled clinical trial. It aims to investigate the safety, efficacy and dose-response of GSK3640254 compared to dolutegravir (DTG), each given in combination with 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs) (abacavir/lamivudine \[ABC/3TC\] or emtricitabine/tenofovir alafenamide \[FTC/TAF\]).

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

A Review of FDA-Approved Anti-HIV-1 Drugs, Anti-Gag Compounds, and Potential Strategies for HIV-1 Eradication.
Sever B, Otsuka M, Fujita M, Ciftci H. · · 2024 · cited 39× · PMID 38612471 · DOI 10.3390/ijms25073659
GSK3640254 Is a Novel HIV-1 Maturation Inhibitor with an Optimized Virology Profile.
Dicker I, Jeffrey JL, Protack T, Lin Z, et al · · 2022 · cited 24× · PMID 34780263 · DOI 10.1128/aac.01876-21
Phase IIa Proof-of-Concept Evaluation of the Antiviral Efficacy, Safety, Tolerability, and Pharmacokinetics of the Next-Generation Maturation Inhibitor GSK3640254.
Spinner CD, Felizarta F, Rizzardini G, Philibert P, et al · · 2022 · cited 19× · PMID 34996113 · DOI 10.1093/cid/ciab1065
A Phase I Evaluation of the Pharmacokinetics and Tolerability of the HIV-1 Maturation Inhibitor GSK3640254 and Tenofovir Alafenamide/Emtricitabine in Healthy Participants.
Pene Dumitrescu T, Joshi SR, Xu J, Zhan J, et al · · 2021 · cited 13× · PMID 33753329 · DOI 10.1128/aac.02173-20
Relative Bioavailability and Food Effect of GSK3640254 Tablet and Capsule Formulations in Healthy Participants.
Johnson M, Pene Dumitrescu T, Joshi SR, Mathew A, et al · · 2022 · cited 4× · PMID 34995417 · DOI 10.1002/cpdd.1051
Intrinsic resistance of HIV-2 and SIV to the maturation inhibitor GSK2838232.
Smith RA, Raugi DN, Nixon RS, Song J, et al · · 2023 · cited 2× · PMID 36652466 · DOI 10.1371/journal.pone.0280568
Efficacy and safety of the HIV-1 maturation inhibitor GSK3640254 plus two NRTIs in adults naive to antiretroviral therapy (DOMINO): 24-week results from a randomised phase 2b study.
Joshi SR, Cordova E, Mitha E, Castagna A, et al · · 2025 · PMID 41357330 · DOI 10.1016/j.eclinm.2025.103567

Verify or expand the search:

Other trials of GSK3640254

Trials testing the same drug.

NCT04900038 — A Clinical Trial of GSK3640254 + Dolutegravir (DTG) in Human Immunodeficiency Virus-1 Infected Treatment-naive Adults · Phase 2 · terminated
NCT04857892 — A Relative Bioavailability and Food-Effect Study of the Fixed Dose Combination of GSK3640254 and Dolutegravir (DTG) in H · Phase 1 · completed
NCT04563845 — Effect of Therapeutic and Supratherapeutic Oral Doses of GSK3640254 on Cardiac Conduction Compared to Placebo and a Sing · Phase 1 · completed
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NCT03984825 — Effect of GSK3640254 on the Pharmacokinetics of a Combination Oral Contraceptive · Phase 1 · completed

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NCT06694753 — Safety and Immunogenicity Study of Three mRNAs Encoding HIV Immunogens in Adult Participants Without HIV and in Overall · Phase 1 · recruiting
NCT07235852 — Pilot Testing Into the Feasibility of the Developed Cognitive Behavioral Therapy Intervention · NA · recruiting
NCT06665646 — Clinical Trial to Evaluate the Safety and Immunogenicity of Hiltonol, Poly-ICLC-adjuvanted CD40.HIVRI.Env (VRIPRO) in Ad · Phase 1 · recruiting

Other ViiV Healthcare trials

Trials by the same sponsor.

NCT07393659 — A Continued Access Study for Participants Transitioning From ViiV Healthcare-sponsored or ViiV Healthcare-collaborative · Phase 3 · not yet recruiting
NCT07525544 — A Study to Investigate the Safety and PK of VH4770359 in Healthy Participants · Phase 1 · not yet recruiting
NCT07275606 — A Study to Investigate Cabotegravir for Neonates Exposed to HIV-1 · Phase 1, PHASE2 · not yet recruiting
NCT07202546 — A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study) · Phase 2 · recruiting
NCT07053384 — A Study to Investigate the Use of VH3810109 With or Without Fostemsavir (FTR) to Reduce the Size and Activity of the Vir · Phase 1 · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04493216 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by ViiV Healthcare
Last refreshed: 26 June 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04493216.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT04493216: DOMINO

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (15 terms)

Sponsor's own description

Publications & conference data

Related trials

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Other recruiting trials for HIV Infections

Other ViiV Healthcare trials

Verify against primary sources