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Company decision to stop compound development. The decision was not based on any safety or efficacy concerns. It reflected the company strategy for portfolio progression.
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| Name | Class |
|---|---|
| Syneos Health | OTHER |
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The purpose of this study was to evaluate the efficacy of GSK3640254 + DTG relative to lamivudine (3TC) + DTG in treatment-naïve adult participants living with human immunodeficiency virus (HIV)-1. The participants were randomized to one of the three doses of blinded GSK3640254 (100, 150, or 200 milligrams [mgs]) or a reference arm of blinded 3TC-each in combination with open label DTG.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK3640254 100 mg + Dolutegravir (DTG) 50 mg | Experimental | Participants with human immunodeficiency virus type 1 (HIV-1) orally received low dose (100 mg) GSK3640254 tablet blinded and 50 mg DTG unblinded. Each participant received one tablet per day of each intervention up to Week 24. |
|
| GSK3640254 150 mg + DTG 50 mg | Experimental | Participants with HIV-1 orally received medium dose (150 mg) GSK3640254 tablet blinded and 50 mg DTG unblinded. Each participant received one tablet per day of each intervention up to Week 24. |
|
| GSK3640254 200 mg + DTG 50 mg | Experimental | Participants with HIV-1 orally received high dose (200 mg) GSK3640254 tablet blinded and 50 mg DTG unblinded. Each participant received one tablet per day of each intervention up to Week 24. |
|
| DTG 50 mg + Lamivudine (3TC) 300 mg | Active Comparator | Participants with HIV-1 orally received unblinded 50 mg DTG one tablet and blinded 300 mg 3TC. Each participant received one capsule per day of each intervention up to Week 24. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK3640254 | Drug | GSK3640254 was available as 25 mg or 100 mg tablets administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 using the Food and Drug Administration (FDA) snapshot algorithm was assessed to evaluate the antiviral activity in HIV-1 infected ART (anti-retroviral therapy)-naïve participants. | At Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Values of HIV-1 RNA Through Week 24 | Plasma samples were collected for quantitative analysis of HIV-1 RNA. Logarithm to base 10 (log 10) values for plasma HIV-1 RNA has been presented. Baseline is defined as the latest non-missing value prior to first dose of treatment according to date and time including unscheduled visits. | At Baseline (Day 1) and Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | ViiV Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Bakersfield | California | 93301 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41357331 | Derived | Joshi SR, Masia M, Mitha E, Castagna A, Cordova E, Ramgopal M, Gaudion A, Karthika S, Oyee J, Bainbridge V, Wynne B, Lataillade M. Efficacy and safety of the HIV-1 maturation inhibitor GSK3640254 plus dolutegravir as a two-drug regimen in adults naive to antiretroviral therapy (DYNAMIC): 24-week results from a randomised phase 2b study. EClinicalMedicine. 2025 Oct 17;89:103566. doi: 10.1016/j.eclinm.2025.103566. eCollection 2025 Nov. |
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IPD for this study will be made available via the Clinical Study Data Request site.
IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
The changes from the planned subsequent analyses were presented as pre-specified in Statistical Analysis Plan. Safety analysis is presented based on the Entire Duration of Treatment Exposure period, which is defined from Day 1 up to end of continued access to treatment post-study termination (Day 478).
This study assessed efficacy, safety and resistance of GSK3640254 in combination with dolutegravir compared to dolutegravir + lamivudine in HIV-1 infected, treatment-naïve adults. The study was terminated by the sponsor after primary analysis (at week 24) as the sponsor determined further development of GSK3640254-containing daily oral regimen would not be differentiated enough from existing 2-drug daily oral regimens. Thus, secondary analyses at week 48 were not evaluated.
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| ID | Title | Description |
|---|---|---|
| FG000 | GSK3640254 100 mg + Dolutegravir (DTG) 50 mg | Participants with human immunodeficiency virus type 1 (HIV-1) orally received low dose (100 mg) GSK3640254 tablet blinded and 50 mg DTG unblinded. Each participant received one tablet per day of each intervention up to Week 24. |
| FG001 | GSK3640254 150 mg + DTG 50 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 11, 2022 | Nov 21, 2023 |
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This is a randomized, parallel-group study.
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The dose level of GSK3640254 in each of the treatment arms containing GSK3640254 was blinded to the research participants and all study personnel during the study through the Week 24 primary endpoint.
| Dolutegravir | Drug | DTG was available as 50 mg tablets administered orally. |
|
| Lamivudine capsules | Drug | 3TC was available as 300 mg capsules administered orally as a blinded treatment. |
|
| Lamivudine tablets | Drug | 3TC was available as 300 mg tablets administered orally as an unblinded treatment. |
|
| Change From Baseline in HIV-1 RNA Through Week 24 | Plasma samples were collected for quantitative analysis of HIV-1 RNA. Logarithm to base 10 (log 10) values for plasma HIV-1 RNA has been presented. Change from Baseline is defined as post-dose visit value minus Baseline value. | At Week 24 compared to baseline (Day 1) |
| Absolute Values of Cluster of Differentiation 4+ (CD4+) T-cell Counts Through Week 24 | Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out to evaluate the immunologic activity. Baseline is defined as the latest non-missing value prior to first dose of treatment according to date and time including unscheduled visits. | At Baseline (Day 1) and Week 24 |
| Change From Baseline in CD4+ T-cell Counts Through Week 24 | Blood samples were collected and CD4+ cell count assessment was carried out to evaluate the immunologic activity. Change from Baseline is defined as post-dose visit value minus Baseline value. | At Week 24 compared to baseline (Day 1) |
| Number of Participants With Serious Adverse Events (SAEs) and Deaths, up to End of Continued Access to Treatment Post-study Termination (Day 478) | An SAE is defined as any serious adverse event that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity and is a congenital anomaly/birth defect. The study was terminated by the sponsor after primary analysis (at week 24). Adverse event data were collected up to end of continued access to treatment post-study termination (Day 478). | From Day 1 up to end of continued access to treatment post-study termination (Day 478) |
| Number of Participants With Adverse Events (AEs) Leading to Discontinuation, up to End of Continued Access to Treatment Post-study Termination (Day 478) | Number of participants who discontinued treatment due to AEs are presented. The study was terminated by the sponsor after primary analysis (at week 24). Adverse event data were collected up to end of continued access to treatment post-study termination (Day 478). | From Day 1 up to end of continued access to treatment post-study termination (Day 478) |
| Number of Participants With Adverse Events of Special Interest (AESIs), up to End of Continued Access to Treatment Post-study Termination (Day 478) | AEs of special interest (AESIs) included AEs related to QT prolongation, gastrointestinal (GI) intolerability/toxicity, psychiatric events, nervous system disorders, skin and subcutaneous tissue disorders and cardiac disorders. The study was terminated by the sponsor after primary analysis (at week 24). Adverse event data were collected up to end of continued access to treatment post-study termination (Day 478). | From Day 1 up to end of continued access to treatment post-study termination (Day 478) |
| Number of Participants Who Develop Genotypic Resistance up to Week 24 | Blood samples were collected for drug resistance testing to assess the development of viral resistance to GSK3640254 through Week 24. New mutations were tabulated by drug class: integrase strand transfer inhibitor (INSTI), non-nucleoside reverse transcriptase inhibitor (NNRTI), nucleoside reverse transcriptase inhibitor (NRTI) and protease inhibitor (PI). Protocol-Defined Virologic Failure (PDVF) was defined as having virologic non-response (HIV-1 RNA <1.0 log10 c/mL reduction from baseline and <200 copies/mL by Week 12, confirmed levels >=200 c/mL at or after Week 24 and plasma HIV-1 RNA <= 50 c/mL from testing on Week 24, virologic rebound (confirmed HIV-1 RNA >=200 copies/mL after confirmed consecutive HIV-1 RNA <50 copies/mL). | From Day 1 up to Week 24 |
| Number of Participants Who Develop Phenotypic Resistance up to Week 24 | Blood samples were collected for drug resistance testing to assess the development of viral resistance to GSK3640254 and other on-study Anti-Retroviral Therapy (ART) in participants experiencing virologic failure through Week 24. Only plasma HIV-1 RNA values determined by the central laboratory were used to assess virologic failure. PDVF was defined as having virologic non-response (HIV-1 RNA <1.0 log10 c/mL reduction from baseline and <200 copies/mL by Week 12, confirmed levels >=200 c/mL at or after Week 24 and plasma HIV-1 RNA <= 50 c/mL from testing on Week 24, virologic rebound (confirmed HIV-1 RNA >=200 copies/mL after confirmed consecutive HIV-1 RNA <50 copies/mL). | From Day 1 up to Week 24 |
| Trough Concentration (Ctrough) of GSK3640254 at Weeks 2, 4, 8, 12 and 24 | Trough concentration (Ctrough) is the concentration reached by a drug immediately before the next dose is administered. This was determined to assess the steady-state exposure of GSK3640254 when given in combination with DTG. | At Weeks 2, 4, 8, 12 (PRE DOSE), 12 (2-6HR POST DOSE), 24 (PRE DOSE), 24 (2-6HR POST DOSE) |
| Palm Springs |
| California |
| 92262 |
| United States |
| GSK Investigational Site | Denver | Colorado | 80246 | United States |
| GSK Investigational Site | Ft. Pierce | Florida | 34982 | United States |
| GSK Investigational Site | Miami | Florida | 33140 | United States |
| GSK Investigational Site | Orlando | Florida | 32806 | United States |
| GSK Investigational Site | Kansas City | Missouri | 64111 | United States |
| GSK Investigational Site | Omaha | Nebraska | 68198 | United States |
| GSK Investigational Site | Ciudad Autónoma de Buenos Aires | Buenos Aires | C1405CKC | Argentina |
| GSK Investigational Site | Buenos Aires | C1202ABB | Argentina |
| GSK Investigational Site | Buenos Aires | C1425AGC | Argentina |
| GSK Investigational Site | Montreal | Quebec | H2L 4E9 | Canada |
| GSK Investigational Site | Montreal | Quebec | H2L 4P9 | Canada |
| GSK Investigational Site | Paris | 75012 | France |
| GSK Investigational Site | Tourcoing | 59208 | France |
| GSK Investigational Site | Frankfurt am Main | Hesse | 60596 | Germany |
| GSK Investigational Site | Cologne | North Rhine-Westphalia | 50668 | Germany |
| GSK Investigational Site | Berlin | 10787 | Germany |
| GSK Investigational Site | Hamburg | 20146 | Germany |
| GSK Investigational Site | Bergamo | Lombardy | 24127 | Italy |
| GSK Investigational Site | Milan | Lombardy | 20127 | Italy |
| GSK Investigational Site | Porto | 4369-004 | Portugal |
| GSK Investigational Site | Vila Nova de Gaia | 4434-502 | Portugal |
| GSK Investigational Site | San Juan | 00909 | Puerto Rico |
| GSK Investigational Site | Durban | 4091 | South Africa |
| GSK Investigational Site | Johannesburg | 2113 | South Africa |
| GSK Investigational Site | Parow | 7505 | South Africa |
| GSK Investigational Site | Vosloorus Ext 2 | 1475 | South Africa |
| GSK Investigational Site | Barcelona | 08036 | Spain |
| GSK Investigational Site | Barcelona | 08907 | Spain |
| GSK Investigational Site | Barcelona | 8003 | Spain |
| GSK Investigational Site | Bilbao | 48013 | Spain |
| GSK Investigational Site | Elche | ?03203 | Spain |
| GSK Investigational Site | La Laguna-Tenerife | 38320 | Spain |
| GSK Investigational Site | Madrid | 28007 | Spain |
| GSK Investigational Site | Madrid | 28031 | Spain |
| GSK Investigational Site | Madrid | 28040 | Spain |
| GSK Investigational Site | Madrid | 28041 | Spain |
| GSK Investigational Site | Madrid | 28046 | Spain |
| GSK Investigational Site | Murcia | 30120 | Spain |
| GSK Investigational Site | Palma de Mallorca | 07198 | Spain |
| GSK Investigational Site | Sant Boi de Llobregat | 08830 | Spain |
| GSK Investigational Site | Valencia | 46026 | Spain |
| GSK Investigational Site | Vigo | 36312 | Spain |
Participants with HIV-1 orally received medium dose (150 mg) GSK3640254 tablet blinded and 50 mg DTG unblinded. Each participant received one tablet per day of each intervention up to Week 24. |
| FG002 | GSK3640254 200 mg + DTG 50 mg | Participants with HIV-1 orally received high dose (200 mg) GSK3640254 tablet blinded and 50 mg DTG unblinded. Each participant received one tablet per day of each intervention up to Week 24. |
| FG003 | DTG 50 mg + Lamivudine (3TC) 300 mg | Participants with HIV-1 orally received unblinded 50 mg DTG one tablet and blinded 300 mg 3TC. Each participant received one capsule per day of each intervention up to Week 24. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | GSK3640254 100 mg + Dolutegravir (DTG) 50 mg | Participants with human immunodeficiency virus type 1 (HIV-1) orally received low dose (100 mg) GSK3640254 tablet blinded and 50 mg DTG unblinded. Each participant received one tablet per day of each intervention up to Week 24. |
| BG001 | GSK3640254 150 mg + DTG 50 mg | Participants with HIV-1 orally received medium dose (150 mg) GSK3640254 tablet blinded and 50 mg DTG unblinded. Each participant received one tablet per day of each intervention up to Week 24. |
| BG002 | GSK3640254 200 mg + DTG 50 mg | Participants with HIV-1 orally received high dose (200 mg) GSK3640254 tablet blinded and 50 mg DTG unblinded. Each participant received one tablet per day of each intervention up to Week 24. |
| BG003 | DTG 50 mg + Lamivudine (3TC) 300 mg | Participants with HIV-1 orally received unblinded 50 mg DTG one tablet and blinded 300 mg 3TC. Each participant received one capsule per day of each intervention up to Week 24. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 using the Food and Drug Administration (FDA) snapshot algorithm was assessed to evaluate the antiviral activity in HIV-1 infected ART (anti-retroviral therapy)-naïve participants. | Analysis was performed on Intent-to-Treat Exposed (ITT-E) Population included all randomized participants who received at least one dose of study intervention and had data for plasma HIV-1 RNA <50 c/mL as per timeline assessed. | Posted | Number | Percentage of participants | At Week 24 |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Absolute Values of HIV-1 RNA Through Week 24 | Plasma samples were collected for quantitative analysis of HIV-1 RNA. Logarithm to base 10 (log 10) values for plasma HIV-1 RNA has been presented. Baseline is defined as the latest non-missing value prior to first dose of treatment according to date and time including unscheduled visits. | Analysis was performed on ITT-E Population that had data for absolute values of HIV-1 RNA as per timeline assessed. | Posted | Mean | Standard Deviation | log10 copies per milliliter(log10 c/mL) | At Baseline (Day 1) and Week 24 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in HIV-1 RNA Through Week 24 | Plasma samples were collected for quantitative analysis of HIV-1 RNA. Logarithm to base 10 (log 10) values for plasma HIV-1 RNA has been presented. Change from Baseline is defined as post-dose visit value minus Baseline value. | Analysis was performed on ITT-E Population that had data for absolute values of HIV-1 RNA as per timeline assessed. | Posted | Mean | Standard Deviation | log10 c/mL | At Week 24 compared to baseline (Day 1) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Absolute Values of Cluster of Differentiation 4+ (CD4+) T-cell Counts Through Week 24 | Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out to evaluate the immunologic activity. Baseline is defined as the latest non-missing value prior to first dose of treatment according to date and time including unscheduled visits. | Analysis was performed on ITT-E Population that had data for CD4+ T-cells analysis as per timeline assessed. | Posted | Mean | Standard Deviation | cells per cubic millimeter (cells/mm^3) | At Baseline (Day 1) and Week 24 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in CD4+ T-cell Counts Through Week 24 | Blood samples were collected and CD4+ cell count assessment was carried out to evaluate the immunologic activity. Change from Baseline is defined as post-dose visit value minus Baseline value. | Analysis was performed on ITT-E Population that had data for CD4+ T-cells analysis as per timeline assessed. | Posted | Mean | Standard Deviation | cells/mm^3 | At Week 24 compared to baseline (Day 1) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Serious Adverse Events (SAEs) and Deaths, up to End of Continued Access to Treatment Post-study Termination (Day 478) | An SAE is defined as any serious adverse event that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity and is a congenital anomaly/birth defect. The study was terminated by the sponsor after primary analysis (at week 24). Adverse event data were collected up to end of continued access to treatment post-study termination (Day 478). | Analysis performed on Safety population, that included all randomized participants who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | From Day 1 up to end of continued access to treatment post-study termination (Day 478) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events (AEs) Leading to Discontinuation, up to End of Continued Access to Treatment Post-study Termination (Day 478) | Number of participants who discontinued treatment due to AEs are presented. The study was terminated by the sponsor after primary analysis (at week 24). Adverse event data were collected up to end of continued access to treatment post-study termination (Day 478). | Analysis performed on Safety population, that included all randomized participants who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | From Day 1 up to end of continued access to treatment post-study termination (Day 478) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events of Special Interest (AESIs), up to End of Continued Access to Treatment Post-study Termination (Day 478) | AEs of special interest (AESIs) included AEs related to QT prolongation, gastrointestinal (GI) intolerability/toxicity, psychiatric events, nervous system disorders, skin and subcutaneous tissue disorders and cardiac disorders. The study was terminated by the sponsor after primary analysis (at week 24). Adverse event data were collected up to end of continued access to treatment post-study termination (Day 478). | Analysis performed on Safety population, that included all randomized participants who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | From Day 1 up to end of continued access to treatment post-study termination (Day 478) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Develop Genotypic Resistance up to Week 24 | Blood samples were collected for drug resistance testing to assess the development of viral resistance to GSK3640254 through Week 24. New mutations were tabulated by drug class: integrase strand transfer inhibitor (INSTI), non-nucleoside reverse transcriptase inhibitor (NNRTI), nucleoside reverse transcriptase inhibitor (NRTI) and protease inhibitor (PI). Protocol-Defined Virologic Failure (PDVF) was defined as having virologic non-response (HIV-1 RNA <1.0 log10 c/mL reduction from baseline and <200 copies/mL by Week 12, confirmed levels >=200 c/mL at or after Week 24 and plasma HIV-1 RNA <= 50 c/mL from testing on Week 24, virologic rebound (confirmed HIV-1 RNA >=200 copies/mL after confirmed consecutive HIV-1 RNA <50 copies/mL). | Analysis was performed on ITT-E population. | Posted | Count of Participants | Participants | From Day 1 up to Week 24 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Develop Phenotypic Resistance up to Week 24 | Blood samples were collected for drug resistance testing to assess the development of viral resistance to GSK3640254 and other on-study Anti-Retroviral Therapy (ART) in participants experiencing virologic failure through Week 24. Only plasma HIV-1 RNA values determined by the central laboratory were used to assess virologic failure. PDVF was defined as having virologic non-response (HIV-1 RNA <1.0 log10 c/mL reduction from baseline and <200 copies/mL by Week 12, confirmed levels >=200 c/mL at or after Week 24 and plasma HIV-1 RNA <= 50 c/mL from testing on Week 24, virologic rebound (confirmed HIV-1 RNA >=200 copies/mL after confirmed consecutive HIV-1 RNA <50 copies/mL). | Analysis was performed on ITT-E Population. | Posted | Count of Participants | Participants | From Day 1 up to Week 24 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Trough Concentration (Ctrough) of GSK3640254 at Weeks 2, 4, 8, 12 and 24 | Trough concentration (Ctrough) is the concentration reached by a drug immediately before the next dose is administered. This was determined to assess the steady-state exposure of GSK3640254 when given in combination with DTG. | Analysis performed on Pharmacokinetic population, which included all participants who received GSK3640254, underwent sparse PK sampling during the study, and provided evaluable GSK3640254 plasma concentration data, demographic and baseline characteristics, and/or information on concomitant medications. Only those participants with data available at specified time points were analyzed for the specific category titles. | Posted | Geometric Mean | 95% Confidence Interval | nanogram per milliliter (ng/mL) | At Weeks 2, 4, 8, 12 (PRE DOSE), 12 (2-6HR POST DOSE), 24 (PRE DOSE), 24 (2-6HR POST DOSE) |
|
All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of continued access to treatment post-study termination (Day 478).
The study was terminated by the sponsor after primary analysis (at week 24). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 478).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GSK3640254 100 mg + Dolutegravir (DTG) 50 mg | Participants with human immunodeficiency virus type 1 (HIV-1) orally received low dose (100 mg) GSK3640254 tablet blinded and 50 mg DTG unblinded. Each participant received one tablet per day of each intervention up to Week 24. | 0 | 22 | 2 | 22 | 16 | 22 |
| EG001 | GSK3640254 150 mg + DTG 50 mg | Participants with HIV-1 orally received medium dose (150 mg) GSK3640254 tablet blinded and 50 mg DTG unblinded. Each participant received one tablet per day of each intervention up to Week 24. | 0 | 20 | 0 | 20 | 15 | 20 |
| EG002 | GSK3640254 200 mg + DTG 50 mg | Participants with HIV-1 orally received high dose (200 mg) GSK3640254 tablet blinded and 50 mg DTG unblinded. Each participant received one tablet per day of each intervention up to Week 24. | 0 | 22 | 0 | 22 | 17 | 22 |
| EG003 | DTG 50 mg + Lamivudine (3TC) 300 mg | Participants with HIV-1 orally received unblinded 50 mg DTG one tablet and blinded 300 mg 3TC. Each participant received one capsule per day of each intervention up to Week 24. | 0 | 21 | 1 | 21 | 14 | 21 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anogenital dysplasia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Non-cardiac chest pain | General disorders | Systematic Assessment |
| ||
| Guillain-Barre syndrome | Nervous system disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | Systematic Assessment |
| ||
| Conjunctivitis | Infections and infestations | Systematic Assessment |
| ||
| Folliculitis | Infections and infestations | Systematic Assessment |
| ||
| Gastroeneteritis | Infections and infestations | Systematic Assessment |
| ||
| Herpes simplex | Infections and infestations | Systematic Assessment |
| ||
| Herpes zoster | Infections and infestations | Systematic Assessment |
| ||
| Influenza | Infections and infestations | Systematic Assessment |
| ||
| Monkeypox | Infections and infestations | Systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Oropharyngeal gonococcal infection | Infections and infestations | Systematic Assessment |
| ||
| Pharyngeal chlamydia infection | Infections and infestations | Systematic Assessment |
| ||
| Pharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Pharyngotonsillitis | Infections and infestations | Systematic Assessment |
| ||
| Respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Sinusitis | Infections and infestations | Systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Urethritis chlamydial | Infections and infestations | Systematic Assessment |
| ||
| Viral infection | Infections and infestations | Systematic Assessment |
| ||
| Abdominal discomfort | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Faeces soft | Gastrointestinal disorders | Systematic Assessment |
| ||
| Haemorrhoids | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Toothache | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Sciatica | Nervous system disorders | Systematic Assessment |
| ||
| Somnolence | Nervous system disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Influenza like illness | General disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Catarrh | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin lesion | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Systematic Assessment |
| ||
| Ligament sprain | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Blood pressure increased | Investigations | Systematic Assessment |
| ||
| Anogenital warts | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Erectile dysfunction | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Vascular disorders Hypertension | Reproductive system and breast disorders | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | ViiV Healthcare | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 19, 2023 | Nov 21, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000723722 | GSK3640254 |
| C562325 | dolutegravir |
| D019259 | Lamivudine |
| ID | Term |
|---|---|
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D015224 | Dideoxynucleosides |
Not provided
Not provided
| Male |
|
| Black or African American |
|
| White |
|
| Mixed Race |
|
| Other - Unspecified |
|
| OG003 | DTG 50 mg + Lamivudine (3TC) 300 mg | Participants with HIV-1 orally received unblinded 50 mg DTG one tablet and blinded 300 mg 3TC.Each participant received one capsule per day of each intervention up to Week 24. |
|
|
| OG003 | DTG 50 mg + Lamivudine (3TC) 300 mg | Participants with HIV-1 orally received unblinded 50 mg DTG one tablet and blinded 300 mg 3TC.Each participant received one capsule per day of each intervention up to Week 24. |
|
|
| OG003 | DTG 50 mg + Lamivudine (3TC) 300 mg | Participants with HIV-1 orally received unblinded 50 mg DTG one tablet and blinded 300 mg 3TC.Each participant received one capsule per day of each intervention up to Week 24. |
|
|
| OG003 | DTG 50 mg + Lamivudine (3TC) 300 mg | Participants with HIV-1 orally received unblinded 50 mg DTG one tablet and blinded 300 mg 3TC.Each participant received one capsule per day of each intervention up to Week 24. |
|
|
| OG002 | GSK3640254 200 mg + DTG 50 mg | Participants with HIV-1 orally received high dose (200 mg) GSK3640254 tablet blinded and 50 mg DTG unblinded. Each participant received one tablet per day of each intervention up to Week 24. |
| OG003 | DTG 50 mg + Lamivudine (3TC) 300 mg | Participants with HIV-1 orally received unblinded 50 mg DTG one tablet and blinded 300 mg 3TC.Each participant received one capsule per day of each intervention up to Week 24. |
|
|
Participants with HIV-1 orally received high dose (200 mg) GSK3640254 tablet blinded and 50 mg DTG unblinded. Each participant received one tablet per day of each intervention up to Week 24. |
| OG003 | DTG 50 mg + Lamivudine (3TC) 300 mg | Participants with HIV-1 orally received unblinded 50 mg DTG one tablet and blinded 300 mg 3TC.Each participant received one capsule per day of each intervention up to Week 24. |
|
|
| OG002 |
| GSK3640254 200 mg + DTG 50 mg |
Participants with HIV-1 orally received high dose (200 mg) GSK3640254 tablet blinded and 50 mg DTG unblinded. Each participant received one tablet per day of each intervention up to Week 24. |
| OG003 | DTG 50 mg + Lamivudine (3TC) 300 mg | Participants with HIV-1 orally received unblinded 50 mg DTG one tablet and blinded 300 mg 3TC.Each participant received one capsule per day of each intervention up to Week 24. |
|
|
| OG002 | GSK3640254 200 mg + DTG 50 mg | Participants with HIV-1 orally received high dose (200 mg) GSK3640254 tablet blinded and 50 mg DTG unblinded. Each participant received one tablet per day of each intervention up to Week 24. |
| OG003 | DTG 50 mg + Lamivudine (3TC) 300 mg | Participants with HIV-1 orally received unblinded 50 mg DTG one tablet and blinded 300 mg 3TC.Each participant received one capsule per day of each intervention up to Week 24. |
|
|
| OG002 | GSK3640254 200 mg + DTG 50 mg | Participants with HIV-1 orally received high dose (200 mg) GSK3640254 tablet blinded and 50 mg DTG unblinded. Each participant received one tablet per day of each intervention up to Week 24. |
| OG003 | DTG 50 mg + Lamivudine (3TC) 300 mg | Participants with HIV-1 orally received unblinded 50 mg DTG one tablet and blinded 300 mg 3TC.Each participant received one capsule per day of each intervention up to Week 24. |
|
|
| OG002 | GSK3640254 200 mg + DTG 50 mg | Participants with HIV-1 orally received high dose (200 mg) GSK3640254 tablet blinded and 50 mg DTG unblinded. Each participant received one tablet per day of each intervention up to Week 24. |
|
|
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|---|---|
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| Title | Measurements |
|---|---|
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