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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.
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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]).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF | Experimental | 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. |
|
| GSK3640254 150 mg + ABC/3TC or FTC/TAF | Experimental | 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. |
|
| GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF | Experimental | 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. |
|
| Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF | Active Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK3640254 | Drug | GSK3640254 was available as a 25 mg and 100 mg tablets to be administered via oral route. |
|
| 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 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. | At Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At Week 48 |
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Inclusion Criteria:
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
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:
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.
Exclusion criteria:
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.
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:
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).
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | ViiV Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Los Angeles | California | 90027 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41357330 | Derived | 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. | |
| 34996113 |
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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, 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 was defined from Day 1 up to end of continued access to treatment post-study termination (Day 922).
This study assessed efficacy, safety and resistance of GSK3640254 in combination with ABC/3TC or FTC/TAF compared to dolutegravir + ABC/3TC or FTC/TAF in HIV-1 infected, treatment-naïve adults. The study was terminated by the sponsor at Week 48 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 96 and Week 144 were not evaluated.
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| ID | Title | Description |
|---|---|---|
| FG000 | GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF | 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. |
| 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 | Oct 1, 2021 | Oct 26, 2023 |
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This is a randomized, multicenter, parallel group study.
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The study treatment assignments was not blinded (GSK3640254 versus Dolutegravir control arm). However, 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. The Sponsor personnel remained blinded until the database lock for the Week 24 analysis.
|
| ABC/3TC | Drug | ABC/3TC was available as abacavir 600 mg/lamivudine 300 mg tablet to be administered via oral route. |
|
| FTC/TAF | Drug | FTC/TAF was available as emtricitabine 200 mg/tenofovir alafenamide 25 mg tablet to be administered via oral route. |
|
| Dolutegravir | Drug | Dolutegravir was available as a 50 mg tablet to be administered via oral route. |
|
| Placebo | Drug | Placebo matching GSK3640254 was administered in the form of tablets via oral route. |
|
| 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. | Baseline (Day 1) and at Weeks 24 and 48 |
| 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. | Baseline (Day 1) and at Weeks 24 and 48 |
| 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. | Baseline (Day 1) and at Weeks 24 and 48 |
| 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. | Baseline (Day 1) and at Weeks 24 and 48 |
| 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. | From Day 1 up to end of continued access to treatment post-study termination (Day 922) |
| 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. | From Day 1 up to end of continued access to treatment post-study termination (Day 922) |
| 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. | From Day 1 up to end of continued access to treatment post-study termination (Day 922) |
| 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. | From Day 1 up to end of continued access to treatment post-study termination (Day 922) |
| 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. | Baseline (Day 1) and at Weeks 24 and 48 |
| 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. | Baseline (Day 1) and at Weeks 24 and 48 |
| 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. | Pre-dose, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 10, and 24 hours post-dose at Week 2 |
| 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. | 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 | Blood samples were collected at indicated time points for PK analysis of GSK3640254. | Pre-dose, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 10, and 24 hours post-dose at Week 2 |
| Maximum Observed Concentration (Cmax) of GSK3640254 at Steady State | Blood samples were collected at indicated time points for PK analysis of GSK3640254. | Pre-dose, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 10, and 24 hours post-dose at Week 2 |
| 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. | Pre-dose, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 10, and 24 hours post-dose at Week 2 |
| 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. | Pre-dose, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 10, and 24 hours post-dose at Week 2 |
| Steady State Oral Clearance (CLt/F) of GSK3640254 | Blood samples were collected at indicated time points for PK analysis of GSK3640254. | Pre-dose, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 10, and 24 hours post-dose at Week 2 |
| Ft. Pierce |
| Florida |
| 34982 |
| United States |
| GSK Investigational Site | Orlando | Florida | 32803 | United States |
| GSK Investigational Site | Orlando | Florida | 32806 | United States |
| GSK Investigational Site | Berkley | Michigan | 48072 | United States |
| GSK Investigational Site | Jackson | Mississippi | 39216-4505 | United States |
| GSK Investigational Site | Omaha | Nebraska | 68198 | United States |
| GSK Investigational Site | Cincinnati | Ohio | 45267-0405 | United States |
| GSK Investigational Site | Dallas | Texas | 75246 | United States |
| GSK Investigational Site | Ciudad Autonoma de Buenos Aires | Buenos Aires | C1128AAF | Argentina |
| GSK Investigational Site | Ciudad Autonoma de Buenos Aires | Buenos Aires | C1207AAP | Argentina |
| GSK Investigational Site | Ciudad Autonoma de Buenos Aires | Buenos Aires | C1425AWK | Argentina |
| GSK Investigational Site | Ciudad Autónoma de Buenos Aires | Buenos Aires | C1405CKC | Argentina |
| GSK Investigational Site | Ciudad de Buenos Aires | Buenos Aires | C1202ABB | Argentina |
| GSK Investigational Site | Buenos Aires | 1141 | Argentina |
| GSK Investigational Site | Buenos Aires | C1425AGC | Argentina |
| GSK Investigational Site | San Juan | 5400 | Argentina |
| GSK Investigational Site | Ottawa | Ontario | K1H 8L6 | Canada |
| GSK Investigational Site | Montreal | Quebec | H2L 4E9 | Canada |
| GSK Investigational Site | Montreal | Quebec | H2L 4P9 | Canada |
| GSK Investigational Site | Montreal | Quebec | H4A 3J1 | Canada |
| GSK Investigational Site | Marseille | 13003 | France |
| GSK Investigational Site | Paris | 75018 | France |
| GSK Investigational Site | Tourcoing | 59208 | France |
| GSK Investigational Site | Munich | Bavaria | 81675 | Germany |
| GSK Investigational Site | Bochum | North Rhine-Westphalia | 44787 | Germany |
| GSK Investigational Site | Cologne | North Rhine-Westphalia | 50674 | Germany |
| GSK Investigational Site | Rome | Lazio | 00149 | Italy |
| GSK Investigational Site | Milan | Lombardy | 20127 | Italy |
| GSK Investigational Site | Milan | Lombardy | 20157 | Italy |
| GSK Investigational Site | Turin | Piedmont | 10149 | Italy |
| GSK Investigational Site | Brescia | 25123 | Italy |
| GSK Investigational Site | Milan | 20157 | Italy |
| GSK Investigational Site | Almada | 2801-951 | Portugal |
| GSK Investigational Site | Aveiro | 3814-501 | Portugal |
| GSK Investigational Site | Porto | 4099-001 | Portugal |
| GSK Investigational Site | Porto | 4200-319 | Portugal |
| GSK Investigational Site | Kazan' | 420061 | Russia |
| GSK Investigational Site | Saint Petersburg | 190103 | Russia |
| GSK Investigational Site | Saint Petersburg | 191167 | Russia |
| GSK Investigational Site | Samara | 443029 | Russia |
| GSK Investigational Site | Smolensk | 214006 | Russia |
| GSK Investigational Site | Johannesburg | Gauteng | 2113 | South Africa |
| GSK Investigational Site | Wentworth | KwaZulu-Natal | 4052 | South Africa |
| GSK Investigational Site | Observatory, Cape Town | 7925 | South Africa |
| GSK Investigational Site | Vosloorus Ext 2 | 1475 | South Africa |
| GSK Investigational Site | A Coruña | 15006 | Spain |
| GSK Investigational Site | Alicante | 03010 | Spain |
| GSK Investigational Site | Badalona, Barcelona | 8916 | Spain |
| GSK Investigational Site | Barcelona | 08025 | Spain |
| GSK Investigational Site | Barcelona | 08035 | Spain |
| GSK Investigational Site | L'Hospitalet de Llobregat | 08907 | Spain |
| GSK Investigational Site | Madrid | 28006 | Spain |
| GSK Investigational Site | Madrid | 28034 | Spain |
| GSK Investigational Site | Madrid | 28040 | Spain |
| GSK Investigational Site | Madrid | 28046 | Spain |
| GSK Investigational Site | Marbella | 29600 | Spain |
| GSK Investigational Site | Málaga | 29010 | Spain |
| GSK Investigational Site | Murcia | 30003 | Spain |
| GSK Investigational Site | Palma de Mallorca | 07010 | Spain |
| GSK Investigational Site | Seville | 41013 | Spain |
| GSK Investigational Site | Seville | 41014 | Spain |
| GSK Investigational Site | Valencia | 46010 | Spain |
| GSK Investigational Site | Valencia | 46014 | Spain |
| GSK Investigational Site | Zurich | 8091 | Switzerland |
| Derived |
| 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. |
| FG001 | GSK3640254 150 mg + ABC/3TC or FTC/TAF | 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. |
| FG002 | GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF | 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. |
| FG003 | Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF | 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF | 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. |
| BG001 | GSK3640254 150 mg + ABC/3TC or FTC/TAF | 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. |
| BG002 | GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF | 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. |
| BG003 | Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF | 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. |
| 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 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. | The analysis was performed on the Intent-to-Treat Exposed (ITT-E) population which included all randomized participants who received at least one dose of study intervention. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Week 24 |
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| Secondary | 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. | The analysis was performed on the ITT-E population which included all randomized participants who received at least one dose of study intervention. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Week 48 |
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| Secondary | 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. | The analysis was performed on the ITT-E population which included all randomized participants who received at least one dose of study intervention. Only those participants with data available at specified time points have been analyzed. | Posted | Mean | Standard Deviation | Log 10 copies per milliliter | Baseline (Day 1) and at Weeks 24 and 48 |
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| Secondary | 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. | The analysis was performed on the ITT-E population which included all randomized participants who received at least one dose of study intervention. Only those participants with data available at specified time points have been analyzed. | Posted | Mean | Standard Deviation | Log 10 copies per milliliter | Baseline (Day 1) and at Weeks 24 and 48 |
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| Secondary | 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. | The analysis was performed on the ITT-E population which included all randomized participants who received at least one dose of study intervention. Only those participants with data available at specified time points have been analyzed. | Posted | Mean | Standard Deviation | Cells per cubic millimeter | Baseline (Day 1) and at Weeks 24 and 48 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The analysis was performed on the ITT-E population which included all randomized participants who received at least one dose of study intervention. Only those participants with data available at specified time points have been analyzed. | Posted | Mean | Standard Deviation | Cells per cubic millimeter | Baseline (Day 1) and at Weeks 24 and 48 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The analysis was performed on the Safety Population, which included all randomized participants who were exposed to study intervention with the exception of any participants with documented evidence of not having consumed any amount of study intervention. | Posted | Count of Participants | Participants | From Day 1 up to end of continued access to treatment post-study termination (Day 922) |
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| Secondary | 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. | The analysis was performed on the Safety Population, which included all randomized participants who were exposed to study intervention with the exception of any participants with documented evidence of not having consumed any amount of study intervention. | Posted | Count of Participants | Participants | From Day 1 up to end of continued access to treatment post-study termination (Day 922) |
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| Secondary | 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. | The analysis was performed on the Safety Population, which included all randomized participants who were exposed to study intervention with the exception of any participants with documented evidence of not having consumed any amount of study intervention. The data presented here is not cumulative data but the number of participants experiencing the adverse event based on maximum grade at the indicated timepoints. | Posted | Count of Participants | Participants | From Day 1 up to end of continued access to treatment post-study termination (Day 922) |
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| Secondary | 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. | The analysis was performed on the Safety Population, which included all randomized participants who were exposed to study intervention with the exception of any participants with documented evidence of not having consumed any amount of study intervention. | Posted | Count of Participants | Participants | From Day 1 up to end of continued access to treatment post-study termination (Day 922) |
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| Secondary | 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. | The analysis was performed on the PDVF Population, which included participants with A. virologic non-response (Decrease from Baseline [Day 1] in plasma HIV-1 RNA of ˂1.0 log10 c/mL unless plasma HIV-1 RNA is <200 c/mL by Week 12; confirmed plasma HIV-1 RNA levels ≥200 c/mL at or after Week 24; plasma HIV-1 RNA ≥50 c/mL on repeat testing of Week 24 results and prior to Week 28) and B. virologic rebound (confirmed plasma HIV-1 RNA ≥200 c/mL after confirmed consecutive plasma HIV-1 RNA <50 c/mL). | Posted | Count of Participants | Participants | Baseline (Day 1) and at Weeks 24 and 48 |
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| Secondary | 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. | The analysis was performed on the PDVF Population. Only those participants with data available at specified time points have been analyzed. | Posted | Count of Participants | Participants | Baseline (Day 1) and at Weeks 24 and 48 |
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| Secondary | 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. | The analysis was performed on the Intensive PK Population, which included all participants who received at least one dose of GSK3640254, had evaluable drug concentrations reported and where samples were collected according to the intensive PK sampling scheme. Only those participants who received GSK3640254 have been analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram/ milliliter (ng/mL) | Pre-dose, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 10, and 24 hours post-dose at Week 2 |
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| Secondary | 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. | The analysis was performed on the Sparse PK Population, which included all participants who received at least one dose of GSK3640254, had evaluable drug concentrations reported and had samples collected according to the sparse PK sampling scheme. Only those participants who received GSK3640254 and had data available at specified time points have been analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram/ milliliter (ng/mL) | At Weeks 24 and 48 |
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| Secondary | 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. | The analysis was performed on the Intensive PK Population. Only those participants who received GSK3640254 and had data available at specified time points have been analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hour*nanogram/ milliliter (h*ng/mL) | Pre-dose, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 10, and 24 hours post-dose at Week 2 |
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| Secondary | Maximum Observed Concentration (Cmax) of GSK3640254 at Steady State | Blood samples were collected at indicated time points for PK analysis of GSK3640254. | The analysis was performed on the Intensive PK Population. Only those participants who received GSK3640254 have been analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 10, and 24 hours post-dose at Week 2 |
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| Secondary | 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. | The analysis was performed on the Intensive PK Population. Only those participants who received GSK3640254 have been analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 10, and 24 hours post-dose at Week 2 |
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| Secondary | 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. | The analysis was performed on the Intensive PK Population. Only those participants who received GSK3640254 have been analyzed. | Posted | Median | Full Range | Hour | Pre-dose, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 10, and 24 hours post-dose at Week 2 |
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| Secondary | Steady State Oral Clearance (CLt/F) of GSK3640254 | Blood samples were collected at indicated time points for PK analysis of GSK3640254. | The analysis was performed on the Intensive PK Population. Only those participants who received GSK3640254 and had data available at specified time points have been analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter/ hour | Pre-dose, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 10, and 24 hours post-dose at Week 2 |
|
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).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
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+ Placebo+ ABC/3TC or FTC/TAF | 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. | 0 | 40 | 2 | 40 | 37 | 40 |
| EG001 | GSK3640254 150 mg + ABC/3TC or FTC/TAF | 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. | 0 | 43 | 7 | 43 | 38 | 43 |
| EG002 | GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF | 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. | 0 | 42 | 2 | 42 | 38 | 42 |
| EG003 | Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF | 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. | 0 | 36 | 2 | 36 | 28 | 36 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis | Gastrointestinal disorders | V25.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | V25.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | V25.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | V25.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | V25.0 | Systematic Assessment |
| |
| Necrotising fasciitis | Infections and infestations | V25.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | V25.0 | Systematic Assessment |
| |
| Limb fracture | Injury, poisoning and procedural complications | V25.0 | Systematic Assessment |
| |
| Anogenital warts | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | V25.0 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | V25.0 | Systematic Assessment |
| |
| Substance dependence | Psychiatric disorders | V25.0 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | V25.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | V25.0 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | V25.0 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | V25.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | V25.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | V25.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | V25.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | V25.0 | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | V25.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | V25.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | V25.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | V25.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | V25.0 | Systematic Assessment |
| |
| Asthenia | General disorders | V25.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | V25.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | V25.0 | Systematic Assessment |
| |
| Chlamydial infection | Infections and infestations | V25.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | V25.0 | Systematic Assessment |
| |
| Gonorrhoea | Infections and infestations | V25.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | V25.0 | Systematic Assessment |
| |
| Monkeypox | Infections and infestations | V25.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | V25.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | V25.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | V25.0 | Systematic Assessment |
| |
| Syphilis | Infections and infestations | V25.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | V25.0 | Systematic Assessment |
| |
| Urethritis | Infections and infestations | V25.0 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | V25.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | V25.0 | Systematic Assessment |
| |
| Anogenital warts | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | V25.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | V25.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | V25.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | V25.0 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | V25.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | V25.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | V25.0 | 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_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 21, 2023 | May 29, 2024 | SAP_004.pdf |
Not provided
| 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 |
Not provided
Not provided
Not provided
| Male |
|
| ASIAN |
|
| BLACK OR AFRICAN AMERICAN |
|
| WHITE |
|
| MIXED RACE |
|
| MISSING |
|
| Differences in percentage of participant |
| -1.0 |
| 2-Sided |
| 95 |
| -13.5 |
| 11.6 |
Differences in percentage of participant = Percentage of participant in GSK3640254 150 mg+ ABC/3TC or FTC/TAF - Percentage of participant in DTG+ ABC/3TC or FTC/TAF |
| Other |
| Differences in percentage of participant | -15.5 | 2-Sided | 95 | -31.2 | 0.3 | Differences in percentage of participant = Percentage of participant in GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF - Percentage of participant in DTG+ ABC/3TC or FTC/TAF | Other |
| OG002 | GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF | 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. |
| OG003 | Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF | 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. |
|
|
| OG002 | GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF | 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. |
| OG003 | Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF | 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. |
|
|
| OG002 | GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF | 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. |
| OG003 | Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF | 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. |
|
|
| OG002 | GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF | 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. |
| OG003 | Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF | 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. |
|
|
| OG002 | GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF | 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. |
| OG003 | Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF | 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. |
|
|
| OG002 | GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF | 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. |
| OG003 | Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF | 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. |
|
|
| OG002 | GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF | 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. |
| OG003 | Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF | 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. |
|
|
| OG001 |
| GSK3640254 150 mg + ABC/3TC or FTC/TAF |
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. |
| OG002 | GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF | 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. |
| OG003 | Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF | 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. |
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| OG002 | GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF | 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. |
| OG003 | Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF | 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. |
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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. |
| OG002 | GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF | 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. |
| OG003 | Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF | 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. |
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| GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF |
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. |
| OG003 | Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF | 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. |
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| OG002 | GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF | 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. |
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| OG002 | GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF | 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. |
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| OG002 |
| GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF |
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. |
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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. |
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| GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF |
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. |
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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. |
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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. |
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