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HIV InfectionsPhase 2DOMINONCT04493216

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

A Phase 2 study testing GSK3640254, ABC/3TC and FTC/TAF in people with HIV Infections, run by ViiV Healthcare at 65 sites in 11 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections
What is being tested?
GSK3640254, ABC/3TC and FTC/TAF
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
161 participants
Where
65 sitesin 11 countries
Study dates
18 Nov 2020to 29 May 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must be 18 years of age inclusive, at the time of signing the informed consent.
  • Treatment-naive, defined as no anti-retrovirals (ARVs) (in combination or monotherapy) received after the diagnosis of HIV-1 infection (for example [e.g.], use of Pre-exposure prophylaxis [PreP] meets inclusion.
  • Documented HIV infection and Screening plasma HIV-1 RNA greater than or equal to (>=)1000 c/mL.
  • Screening CD4+ T-cell count >=250 cells/mm^3.
  • Antiviral susceptibility to the NRTI backbone selected should be demonstrated
  • Body weight >=50.0 kilograms (kg) (110 pounds [lbs]) for men and >=45.0 kg (99 lbs) for women and body mass index (BMI) greater than (>)18.5 kg/meter square (m^2).Calculations utilized sex assigned at birth
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  • Participants who are male at birth and participants who are female at birth.
  • Participants who are female at birth: Contraceptive use by participant who are female at birth should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • A participant who was female at birth was eligible to participate if they were not pregnant or breastfeeding, and one of the following conditions applies:
  • Was a participant of non-childbearing potential (PONCBP)
  • Or was a POCBP and using an acceptable contraceptive method during the study intervention period (at a minimum until after the last dose of study intervention).
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
  • For participants enrolled in France: a participant was eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.

Who cannot join

  • Any evidence of an active Center for Disease Control and Prevention (CDC) Stage 3 disease, except cutaneous Kaposi's sarcoma not requiring systemic therapy.
  • Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical, anal or penile intraepithelial neoplasia.
  • Presence of primary HIV-1 infection, evidenced by acute retroviral syndrome (e.g., fever, malaise, fatigue) and/or evidence of recent (within 3 months) documented viremia without antibody production and/or evidence of recent (within 3 months) documented seroconversion.
  • Known history of liver cirrhosis with or without viral hepatitis co-infection.
  • Unstable liver disease (as defined by any of the following: presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice or cirrhosis), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment).
  • History of ongoing or clinically relevant hepatitis within the previous 6 months.
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  • History of drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates their participation.
  • Any history of significant underlying psychiatric disorder, in the opinion of the Investigator or ViiV Medical Monitor, including but not limited to schizophrenia, bipolar disorder with or without psychotic symptoms, other psychotic disorders, or schizotypal (personality) disorder or a clinical assessment of suicidality based on the responses on the Columbia-Suicide Severity Rating Scale (eCSSRS).
  • Any history of major depressive disorder with or without suicidal features, or anxiety disorders, that required medical intervention (pharmacologic or not) such as hospitalization or other inpatient treatment and/or chronic (>6 months) outpatient treatment.
  • Any pre-existing physical or other psychiatric condition (including alcohol or drug abuse), which, in the opinion of the Investigator or ViiV Medical Monitor (with or without psychiatric evaluation), could interfere with the participant's ability to comply with the dosing schedule and protocol evaluations or which might compromise the safety of the participant.
  • A pre-existing condition, in the opinion of the Investigator or ViiV Medical Monitor, that could interfere with normal gastrointestinal anatomy or motility (e.g., gastroesophageal reflux disease [GERD], gastric ulcers, gastritis, inflammatory bowel disease), hepatic and/or renal function, or with the absorption, metabolism, and/or excretion of the study drugs or render the participant unable to take oral study treatment.
  • Myocardial infarction in the past 3 months.
  • Familial or personal history of long QT syndrome or sudden cardiac death.
  • Medical history, current or historical, of significant cardiac arrhythmias or Electrocardiogram (ECG) findings which, in the opinion of the Investigator or ViiV Medical Monitor, will interfere with the safety of the participant.
  • Active Treatment for a viral infection other than HIV-1, such as Hepatitis B, with an agent that is active against HIV-1 (were known to be infected with HIV-1 after treatment for Hepatitis B was completed).
  • Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening.
  • Treatment with any of the following agents within 28 days of Screening: radiation therapy, cytotoxic chemotherapeutic agents, any systemic immune suppressant.
  • Participants receiving any protocol-prohibited medication and who are unwilling or unable to switch to an alternate medication.
  • Participants who are unwilling to stop any medications as required by the local lab test for Helicobacter (H.) pylori.
  • Participants who require concomitant medications known to be associated with a prolonged Corrected QT interval (QTc).
  • Exposure to an experimental drug, human blood product, monoclonal antibody, or vaccine (which does not have emergency, conditional or standard market authorization) within 28 days prior to the first dose of study treatment.
  • Current enrollment or past participation within the last 30 days before signing of consent in any other clinical study involving an investigational study intervention (including an investigational Coronavirus Disease (COVID) vaccine) or any other type of medical research.
  • Any evidence of viral resistance based on the NRTI backbone selected.
  • Historical evidence (prior to study screening period) of the presence of resistance- associated mutations gag A364V or A364A/V.
  • Creatinine Clearance <50 mL/minute.
  • Alanine aminotransferase (ALT) >=3 times upper limit of normal (ULN) or ALT >=2 times ULN and total bilirubin >=1.5 times ULN.
  • Evidence of Hepatitis B virus (HBV) infection based on the results of testing for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti-HBc), Hepatitis B surface antibody (anti-HBs) and reflex HBV deoxyribonucleic acid (DNA) as follows:
  • Participants positive for HBsAg were excluded;
  • Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA on reflex testing were excluded.
  • Positive Hepatitis C antibody test result at Screening and positive on reflex to Hepatitis C RNA.
  • Positive test results for H. pylori;
  • Known or suspected active COVID-19 infection or contact with an individual with known COVID-19, within 14 days of study enrollment
  • Untreated syphilis infection (positive rapid plasma reagin [RPR] at Screening) without documentation of treatment.
  • Presence of moderate-to-severe hepatic impairment (Class B or C) as determined by Child-Pugh classification.
  • Any acute laboratory abnormality at Screening, which, in the opinion of the investigator or ViiV Medical Monitor, would preclude participation in the study of an investigational compound.
  • Urine Drug Screen positive (showing presence of): Amphetamines, Barbiturates, Cocaine, 3,4-Methyl enedioxy methamphetamine (MDMA) or Phencyclidine, or non-prescribed opiates, oxycodone, benzodiazepines, methadone, methamphetamines or tricyclic antidepressants.
  • Any clinically relevant Grade 4 laboratory abnormality at Screen, including results for creatine phosphokinase (CPK) and lipid abnormalities that lack a compelling explanation from the Investigator.
  • Where participation in the study would result in donation of blood or blood products in excess of 500 mL within 28 days.
  • Exposure to more than 4 new investigational drugs or vaccines (exclusive of a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) potential indication within 12 months prior to the first dosing day;
  • Treatment with radiation therapy or cytotoxic chemotherapeutic agents or any systemic immunosuppressive agent within 30 days of study drug administration or anticipated need for such treatment within the study;
  • ECG Heart Rate <50 beats per minute (bpm) or >100 bpm, or QT duration corrected for heart rate by Fridericia's formula (QTcF) >450 milliseconds (msec).
  • For Portugal only: HIV-2 infection (either determined by prior testing, medical history, or obtained locally during the Screening window).

Trial locations and contacts

65 sites in 11 countries.

65 sites in 11 countries

Spain18 sites

  • GSK Investigational Site

    A Coruña, 15006

  • GSK Investigational Site

    Alicante, 03010

  • GSK Investigational Site

    Badalona, Barcelona, 8916

  • GSK Investigational Site

    Barcelona, 08025

  • GSK Investigational Site

    Barcelona, 08035

  • GSK Investigational Site

    L'Hospitalet de Llobregat, 08907

  • GSK Investigational Site

    Madrid, 28006

  • GSK Investigational Site

    Madrid, 28034

  • GSK Investigational Site

    Madrid, 28040

  • GSK Investigational Site

    Madrid, 28046

  • GSK Investigational Site

    Málaga, 29010

  • GSK Investigational Site

    Marbella, 29600

  • GSK Investigational Site

    Murcia, 30003

  • GSK Investigational Site

    Palma de Mallorca, 07010

  • GSK Investigational Site

    Seville, 41013

  • GSK Investigational Site

    Seville, 41014

  • GSK Investigational Site

    Valencia, 46010

  • GSK Investigational Site

    Valencia, 46014

Other trials in Spain

United States9 sites

  • GSK Investigational Site

    Berkley, Michigan, 48072

  • GSK Investigational Site

    Cincinnati, Ohio, 45267-0405

  • GSK Investigational Site

    Dallas, Texas, 75246

  • GSK Investigational Site

    Ft. Pierce, Florida, 34982

  • GSK Investigational Site

    Jackson, Mississippi, 39216-4505

  • GSK Investigational Site

    Los Angeles, California, 90027

  • GSK Investigational Site

    Omaha, Nebraska, 68198

  • GSK Investigational Site

    Orlando, Florida, 32803

  • GSK Investigational Site

    Orlando, Florida, 32806

Other trials in United States

Argentina8 sites

  • GSK Investigational Site

    Buenos Aires, 1141

  • GSK Investigational Site

    Buenos Aires, C1425AGC

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1128AAF

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1207AAP

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1425AWK

  • GSK Investigational Site

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1405CKC

  • GSK Investigational Site

    Ciudad de Buenos Aires, Buenos Aires, C1202ABB

  • GSK Investigational Site

    San Juan, 5400

Other trials in Argentina

Italy6 sites

  • GSK Investigational Site

    Brescia, 25123

  • GSK Investigational Site

    Milan, Lombardy, 20127

  • GSK Investigational Site

    Milan, Lombardy, 20157

  • GSK Investigational Site

    Milan, 20157

  • GSK Investigational Site

    Rome, Lazio, 00149

  • GSK Investigational Site

    Turin, Piedmont, 10149

Other trials in Italy

Russia5 sites

  • GSK Investigational Site

    Kazan', 420061

  • GSK Investigational Site

    Saint Petersburg, 190103

  • GSK Investigational Site

    Saint Petersburg, 191167

  • GSK Investigational Site

    Samara, 443029

  • GSK Investigational Site

    Smolensk, 214006

Other trials in Russia

Canada4 sites

  • GSK Investigational Site

    Montreal, Quebec, H2L 4E9

  • GSK Investigational Site

    Montreal, Quebec, H2L 4P9

  • GSK Investigational Site

    Montreal, Quebec, H4A 3J1

  • GSK Investigational Site

    Ottawa, Ontario, K1H 8L6

Other trials in Canada

Portugal4 sites

  • GSK Investigational Site

    Almada, 2801-951

  • GSK Investigational Site

    Aveiro, 3814-501

  • GSK Investigational Site

    Porto, 4099-001

  • GSK Investigational Site

    Porto, 4200-319

Other trials in Portugal

South Africa4 sites

  • GSK Investigational Site

    Johannesburg, Gauteng, 2113

  • GSK Investigational Site

    Observatory, Cape Town, 7925

  • GSK Investigational Site

    Vosloorus Ext 2, 1475

  • GSK Investigational Site

    Wentworth, KwaZulu-Natal, 4052

Other trials in South Africa

France3 sites

  • GSK Investigational Site

    Marseille, 13003

  • GSK Investigational Site

    Paris, 75018

  • GSK Investigational Site

    Tourcoing, 59208

Other trials in France

Germany3 sites

  • GSK Investigational Site

    Bochum, North Rhine-Westphalia, 44787

  • GSK Investigational Site

    Cologne, North Rhine-Westphalia, 50674

  • GSK Investigational Site

    Munich, Bavaria, 81675

Other trials in Germany

Switzerland1 site

  • GSK Investigational Site

    Zurich, 8091

Other trials in Switzerland

About this study

Official title: A Phase IIb, Randomized, Partially Blind, Active Controlled, Dose-range Finding Study of GSK3640254 Compared to a Reference Arm of Dolutegravir, Each in Combination With Nucleoside Reverse Transcriptase Inhibitors, in HIV-1 Infected Antiretroviral Treatment-naive Adults

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]).

Conditions
HIV Infections
Being tested
GSK3640254, ABC/3TC, FTC/TAF, Dolutegravir, Placebo
Keywords
HIV infection, GSK3640254, Nucleoside Reverse Transcriptase Inhibitor, Dolutegravir, Abacavir (ABC)/Lamivudine (3TC), Emtricitabine (FTC)/tenofovir alafenamide (TAF), Maturation Inhibitor
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GSK3640254Drug

    GSK3640254 was available as a 25 mg and 100 mg tablets to be administered via oral route.

  • ABC/3TCDrug

    ABC/3TC was available as abacavir 600 mg/lamivudine 300 mg tablet to be administered via oral route.

  • FTC/TAFDrug

    FTC/TAF was available as emtricitabine 200 mg/tenofovir alafenamide 25 mg tablet to be administered via oral route.

  • DolutegravirDrug

    Dolutegravir was available as a 50 mg tablet to be administered via oral route.

  • PlaceboDrug

    Placebo matching GSK3640254 was administered in the form of tablets via oral route.

Study groups in NCT04493216
Study groupRoleWhat they receive
GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAFExperimentalParticipants 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.
Receives: Drug: GSK3640254; Drug: ABC/3TC; Drug: FTC/TAF; Drug: Placebo
GSK3640254 150 mg + ABC/3TC or FTC/TAFExperimentalParticipants 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.
Receives: Drug: GSK3640254; Drug: ABC/3TC; Drug: FTC/TAF
GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAFExperimentalParticipants 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.
Receives: Drug: GSK3640254; Drug: ABC/3TC; Drug: FTC/TAF; Drug: Placebo
Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAFActive comparatorParticipants 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.
Receives: Drug: ABC/3TC; Drug: FTC/TAF; Drug: Dolutegravir

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: At Week 24

Secondary outcomes (18)

  1. Percentage of Participants With Plasma HIV-1 RNA <50 c/mL 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.

    Measured: At Week 48

  2. Absolute Values of HIV-1 RNA 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.

    Measured: Baseline (Day 1) and at Weeks 24 and 48

  3. Change From Baseline in Plasma HIV-1 RNA 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.

    Measured: Baseline (Day 1) and at Weeks 24 and 48

  4. Absolute Values of Cluster of Differentiation 4 Plus (CD4+) Cell Counts 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.

    Measured: Baseline (Day 1) and at Weeks 24 and 48

  5. Change From Baseline in CD4+ Cell Counts 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. Change from Baseline is defined as post-dose visit value minus Baseline value.

    Measured: Baseline (Day 1) and at Weeks 24 and 48

  6. Number of Participants With Serious Adverse Events (SAEs) and Deaths

    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.

    Measured: From Day 1 up to end of continued access to treatment post-study termination (Day 922)

  7. Number of Participants With Adverse Events (AEs) Leading to Treatment Discontinuation

    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. Number of participants who discontinued study treatment due to AEs are presented.

    Measured: From Day 1 up to end of continued access to treatment post-study termination (Day 922)

  8. Number of Participants With AEs Based on Maximum Severity Grades

    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.

    Measured: From Day 1 up to end of continued access to treatment post-study termination (Day 922)

  9. Number of Participants With AEs of Special Interest (AESI)

    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. Number of participants with AESI (gastrointestinal (GI), nervous system, and psychiatric AEs) are presented.

    Measured: From Day 1 up to end of continued access to treatment post-study termination (Day 922)

  10. Number of Participants With Genotypic Resistance

    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.

    Measured: Baseline (Day 1) and at Weeks 24 and 48

  11. Number of Participants With Phenotypic Resistance

    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.

    Measured: Baseline (Day 1) and at Weeks 24 and 48

  12. Observed Plasma Concentration at the End of the Dosing Interval (Ctau) of GSK3640254 at Steady State - Week 2

    Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of GSK3640254. Observed plasma concentration at the end of the dosing interval was determined directly from the concentration-time data.

    Measured: Pre-dose, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 10, and 24 hours post-dose at Week 2

  13. Observed Plasma Concentration at the End of the Dosing Interval (Ctau) of GSK3640254 at Steady State - Weeks 24 and 48

    Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of GSK3640254. Observed plasma concentration at the end of the dosing interval was determined directly from the concentration-time data.

    Measured: At Weeks 24 and 48

  14. 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

    Blood samples were collected at indicated time points for PK analysis of GSK3640254.

    Measured: Pre-dose, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 10, and 24 hours post-dose at Week 2

  15. Maximum Observed Concentration (Cmax) of GSK3640254 at Steady State

    Blood samples were collected at indicated time points for PK analysis of GSK3640254.

    Measured: Pre-dose, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 10, and 24 hours post-dose at Week 2

  16. Observed Pre-dose Plasma Concentration (C0) of GSK3640254 at Steady State

    Blood samples were collected at indicated time points for PK analysis of GSK3640254. Observed pre-dose plasma concentration was determined directly from the concentration-time data.

    Measured: Pre-dose, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 10, and 24 hours post-dose at Week 2

  17. Time to Cmax (Tmax) of GSK3640254 at Steady State

    Blood samples were collected at indicated time points for PK analysis of GSK3640254. Tmax was determined directly from the concentration-time data.

    Measured: Pre-dose, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 10, and 24 hours post-dose at Week 2

  18. Steady State Oral Clearance (CLt/F) of GSK3640254

    Blood samples were collected at indicated time points for PK analysis of GSK3640254.

    Measured: Pre-dose, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 10, and 24 hours post-dose at Week 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2020
  2. Study start18 Nov 2020
  3. Primary completion5 Sep 2022
  4. Study completion29 May 2023

Why it stopped: Company decision to stop compound development. The decision is not based on any safety or efficacy concerns. It reflects the company strategy for portfolio progression.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a randomized, multicenter, parallel group study.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
161 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04493216
Sponsor's protocol ID
208379
Acronym
DOMINO
Status last verified
May 2024
First submitted
10 Jul 2020
Last updated
26 Jun 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Publications

  • Joshi SR, Cordova E, Mitha E, Castagna A, Ramgopal M, Llibre JM, Potthoff A, Chernova OE, Nunez SA, Man C, Jeffrey JL, Fishman C, Oyee J, Joshi A, Zhang Y, Bainbridge V, Wynne B, Lataillade M. 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. EClinicalMedicine. 2025 Oct 17;89:103567. doi: 10.1016/j.eclinm.2025.103567. eCollection 2025 Nov.

    PubMed 41357330

  • Spinner CD, Felizarta F, Rizzardini G, Philibert P, Mitha E, Domingo P, Stephan CJ, DeGrosky M, Bainbridge V, Zhan J, Dumitrescu TP, Jeffrey JL, Xu J, Halliday F, Gan J, Johnson M, Gartland M, Joshi SR, Lataillade M. Phase IIa Proof-of-Concept Evaluation of the Antiviral Efficacy, Safety, Tolerability, and Pharmacokinetics of the Next-Generation Maturation Inhibitor GSK3640254. Clin Infect Dis. 2022 Sep 14;75(5):786-794. doi: 10.1093/cid/ciab1065.

    PubMed 34996113

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GSK3640254, ABC/3TC and FTC/TAF in people with HIV Infections, run by ViiV Healthcare at 65 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 sites in Spain, United States, Argentina, Italy, Russia and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<)50 Copies Per Milliliter (c/mL) at Week 24 (time frame: At Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04493216, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024.

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DOMINO Clinical Trial NCT04493216 | AzTrials