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Nucleoside Reverse Transcriptase Inhibitor
GSK3640254 + ABC/3TC + FTC/TAF + Dolutegravir for Human Immunodeficiency Virus Infection (DOMINO Trial)
Phase 2
Waitlist Available
Research Sponsored by ViiV Healthcare
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 10, and 24 hours post-dose at week 2
Awards & highlights
DOMINO Trial Summary
This trial will compare the safety and efficacy of GSK3640254 to the DTG, each given with 2 NRTIs, in order to find the best dose of GSK3640254.
DOMINO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-dose, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 10, and 24 hours post-dose at week 2
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 10, and 24 hours post-dose at week 2
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<)50 Copies Per Milliliter (c/mL) at Week 24
Secondary outcome measures
Absolute Values of Cluster of Differentiation 4 Plus (CD4+) Cell Counts at Week 96
Absolute Values of Cluster of Differentiation 4 Plus (CD4+) Cell Counts at Weeks 24 and 48
Absolute Values of HIV-1 RNA at Week 96
+26 moreSide effects data
From 2020 Phase 2 trial • 34 Patients • NCT0378407917%
Vomiting
17%
Lymphadenopathy
17%
Alanine aminotransferase increased
17%
Chromaturia
17%
Diarrhoea
17%
Insulin resistance
17%
Hyperglycaemia
17%
Nausea
17%
Myocarditis
17%
Meningococcal infection
17%
Vitamin D deficiency
17%
Spinal pain
17%
Aspartate aminotransferase increased
17%
Congestive cardiomyopathy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part 1: GSK3640254 10 mg
Part 2: Placebo
Part 1: Placebo
Part 2: GSK3640254 40 mg
Part 2: GSK3640254 80 mg
Part 2: GSK3640254 140 mg
Part 1: GSK3640254 200 mg
DOMINO Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Blinded GSK3640254 200 mg + GSK3640254 matching placebo + Open Label ABC/3TC or FTC/TAFExperimental Treatment4 Interventions
Group II: Blinded GSK3640254 150 mg + Open Label ABC/3TC or FTC/TAFExperimental Treatment3 Interventions
Group III: Blinded GSK3640254 100 mg + GSK3640254 matching placebo + Open Label ABC/3TC or FTC/TAFExperimental Treatment4 Interventions
Group IV: Open Label DTG + Open Label ABC/3TC or FTC/TAFActive Control3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ABC/3TC
2015
Completed Phase 4
~2630
Placebo
1995
Completed Phase 3
~2670
GSK3640254
2019
Completed Phase 2
~320
FTC/TAF
2021
Completed Phase 4
~540
Find a Location
Who is running the clinical trial?
ViiV HealthcareLead Sponsor
359 Previous Clinical Trials
468,374 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorViiV Healthcare
3,595 Previous Clinical Trials
6,143,761 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Both males and females can participate in the study.You have a history of serious mental health problems like schizophrenia or bipolar disorder, or you have shown signs of suicidal behavior in a recent assessment.You have a history of severe depression or anxiety that required hospitalization or long-term outpatient treatment.You or someone in your family has a history of sudden heart problems that affect the rhythm of your heartbeat.You are currently being treated for a viral infection other than HIV-1, like Hepatitis B, with medication that is also effective against HIV-1.You have not been treated with any anti-retroviral drugs since being diagnosed with HIV-1 infection. The use of Pre-exposure prophylaxis (PreP) is allowed.You have a sufficient amount of a type of white blood cell called CD4+ T-cells, with a count of at least 250 cells per millimeter cubed of blood.You need to show that the antiviral medication chosen will work for you.If you were born female, you must use birth control methods that follow local regulations for participating in clinical studies.You have received radiation therapy, chemotherapy or any medication that weakens your immune system within the last 30 days or you are expected to receive such treatment during the study.You cannot become pregnant.You have a history of allergic reactions to certain drugs or substances that would prevent you from safely participating in this trial, according to the investigator or medical monitor.You must weigh at least 110 pounds if you are a man and 99 pounds if you are a woman, and your body mass index (BMI) is greater than 18.5 kg/meter square. This will be calculated based on the sex you were assigned at birth.You must be 18 years old or older when you agree to take part in the study.You have HIV and your blood test shows a high amount of HIV-1 RNA.If you are a person with the potential to become pregnant, you must use a reliable form of birth control throughout the study and for some time after the study ends.
Research Study Groups:
This trial has the following groups:- Group 1: Blinded GSK3640254 150 mg + Open Label ABC/3TC or FTC/TAF
- Group 2: Open Label DTG + Open Label ABC/3TC or FTC/TAF
- Group 3: Blinded GSK3640254 200 mg + GSK3640254 matching placebo + Open Label ABC/3TC or FTC/TAF
- Group 4: Blinded GSK3640254 100 mg + GSK3640254 matching placebo + Open Label ABC/3TC or FTC/TAF
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA granted authorization for GSK3640254?
"Our team at Power assigned GSK3640254 a score of 2 to reflect its Phase 2 trial status. This indicates that there is some evidence supporting the drug's safety, but no proof yet for efficacy."
Answered by AI
Are there any available positions in this clinical trial?
"This trial, which was initially advertised on November 18th 2020 and updated as recently as October 24th 2022, is not currently looking for participants. However, according to clinicaltrials.gov there are 517 alternative medical studies that are actively recruiting individuals at this moment in time."
Answered by AI
What is the current enrollment capacity of this research project?
"Unfortunately, recruiting for this particular trial has temporarily been halted. Originally posted on 18th November 2020 and last modified 24th October 2022, the study is no longer accepting applications at present. If you are looking for other medical trials related to HIV or GSK3640254 there are currently 485 and 32 studies actively searching respectively."
Answered by AI
Are there ample locations operating this experiment across the US?
"Recruitment is currently underway at 9 distinct medical sites, including Fort Pierce, Jackson and Berkley. It would be prudent to pick the closest centre in order to reduce any potential travel-related burdens associated with taking part in this trial."
Answered by AI
Could you provide a synopsis of the experiments conducted with GSK3640254?
"GSK3640254 was first researched at the University of Zurich in 2002 and, since then, 18430 trials have been concluded. Currently there are 32 active studies taking place across multiple sites but many are hosted out of Fort Pierce, Florida."
Answered by AI
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