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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

Summary

This trial is testing a new HIV drug called GSK3640254 and comparing it to an existing drug, dolutegravir. It aims to find out which drug is safer and more effective for people with HIV. Dolutegravir is known for its safety and effectiveness.

Eligible Conditions

Human Immunodeficiency Virus (HIV) Infection
Inflammation

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 10, and 24 hours post-dose at week 2 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Absolute Values of Cluster of Differentiation 4 Plus (CD4+) Cell Counts at Weeks 24 and 48

Absolute Values of HIV-1 RNA at Weeks 24 and 48

Area Under the Plasma Drug Concentration-time Curve From Pre-dose to the End of the Dosing Interval (AUC [0-tau]) of GSK3640254 at Steady State

+15 more

Side effects data

From 2020 Phase 2 trial • 34 Patients • NCT03784079

17%

Epistaxis

17%

Fatigue

17%

Presyncope

17%

Viral infection

17%

Diarrhoea

17%

Headache

100%

80%

60%

40%

20%

Study treatment Arm

Part 2: GSK3640254 40 mg

Part 2: GSK3640254 80 mg

Part 2: Placebo

Part 1: GSK3640254 10 mg

Part 1: GSK3640254 200 mg

Part 1: Placebo

Part 2: GSK3640254 140 mg

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAFExperimental Treatment4 Interventions

Participants with HIV-1, orally received two 100 mg tablets (200 mg) per day of GSK3640254 and one tablet per day of matching placebo in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.

Group II: GSK3640254 150 mg + ABC/3TC or FTC/TAFExperimental Treatment3 Interventions

Participants with HIV-1, orally received 150 mg (one 100 mg tablet + two 25 mg tablets per day) of GSK3640254 in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.

Group III: GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAFExperimental Treatment4 Interventions

Participants with human immunodeficiency virus type 1 (HIV-1), orally received one 100 mg tablet per day of GSK3640254 and two tablets per day of matching placebo in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day of 600 mg abacavir (ABC) / 300 mg lamivudine (3TC) OR 200 mg emtricitabine (FTC) / 25 mg tenofovir alafenamide (TAF) orally.

Group IV: Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAFActive Control3 Interventions

Participants with HIV-1, orally received one 50 mg tablet per day of DTG in an open label setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

FTC/TAF

2021

Completed Phase 4

~540