A Clinical Trial of GSK3640254 + Dolutegravir (DTG) in Human Immunodeficiency Virus-1 Infected Treatment-naive Adults
NCT ID: NCT04900038
Last Updated: 2023-12-14
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE2
85 participants
INTERVENTIONAL
2021-08-18
2023-05-11
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
GSK3640254
GSK3640254 was available as 25 mg or 100 mg tablets administered orally.
Dolutegravir
DTG was available as 50 mg tablets administered orally.
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.
GSK3640254
GSK3640254 was available as 25 mg or 100 mg tablets administered orally.
Dolutegravir
DTG was available as 50 mg tablets administered orally.
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.
GSK3640254
GSK3640254 was available as 25 mg or 100 mg tablets administered orally.
Dolutegravir
DTG was available as 50 mg tablets administered orally.
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.
Dolutegravir
DTG was available as 50 mg tablets administered orally.
Lamivudine capsules
3TC was available as 300 mg capsules administered orally as a blinded treatment.
Lamivudine tablets
3TC was available as 300 mg tablets administered orally as an unblinded treatment.
Interventions
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GSK3640254
GSK3640254 was available as 25 mg or 100 mg tablets administered orally.
Dolutegravir
DTG was available as 50 mg tablets administered orally.
Lamivudine capsules
3TC was available as 300 mg capsules administered orally as a blinded treatment.
Lamivudine tablets
3TC was available as 300 mg tablets administered orally as an unblinded treatment.
Eligibility Criteria
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Inclusion Criteria
* Documented HIV infection and Screening plasma HIV-1 RNA greater than or equal to (\>=)1000 c/mL.
* Screening CD4+ T-cell count \>=250 cells per millimeter\^3 (cells/cubic millimeter).
* Body weight \>=50.0 kilograms (kg) (110 pounds \[lbs.\]) for men and \>=45.0 kg (99 lbs.) for women and body mass index (BMI) \>18.5 kilograms per meter\^2 (kg/meter square). Calculations will utilize sex assigned at birth.
Exclusion Criteria
* Presence of primary HIV infection, evidenced by acute retroviral syndrome (example \[e.g.\], fever, malaise, fatigue, etc.) and/or evidence of recent (within 3 months) documented viremia without antibody production and/or evidence of recent (within 3 months) documented seroconversion.
* 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.
* Any history of significant underlying psychiatric disorder.
* 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.
* A pre-existing condition, in the opinion of the Investigator or 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 interventions or render the participant unable to take oral study treatment.
* Familial or personal history of long QT syndrome or sudden cardiac death.
* 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).
* Participants who require concomitant medications known to be associated with a prolonged corrected QT (QTc) interval.
* 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.
18 Years
ALL
No
Sponsors
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Syneos Health
OTHER
ViiV Healthcare
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
ViiV Healthcare
Locations
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GSK Investigational Site
Bakersfield, California, United States
GSK Investigational Site
Palm Springs, California, United States
GSK Investigational Site
Denver, Colorado, United States
GSK Investigational Site
Ft. Pierce, Florida, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Orlando, Florida, United States
GSK Investigational Site
Kansas City, Missouri, United States
GSK Investigational Site
Omaha, Nebraska, United States
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
GSK Investigational Site
Buenos Aires, , Argentina
GSK Investigational Site
Buenos Aires, , Argentina
GSK Investigational Site
Montreal, Quebec, Canada
GSK Investigational Site
Montreal, Quebec, Canada
GSK Investigational Site
Paris, , France
GSK Investigational Site
Tourcoing, , France
GSK Investigational Site
Frankfurt am Main, Hesse, Germany
GSK Investigational Site
Cologne, North Rhine-Westphalia, Germany
GSK Investigational Site
Berlin, , Germany
GSK Investigational Site
Hamburg, , Germany
GSK Investigational Site
Bergamo, Lombardy, Italy
GSK Investigational Site
Milan, Lombardy, Italy
GSK Investigational Site
Porto, , Portugal
GSK Investigational Site
Vila Nova de Gaia, , Portugal
GSK Investigational Site
San Juan, , Puerto Rico
GSK Investigational Site
Durban, , South Africa
GSK Investigational Site
Johannesburg, , South Africa
GSK Investigational Site
Parow, , South Africa
GSK Investigational Site
Vosloorus Ext 2, , South Africa
GSK Investigational Site
Barcelona, , Spain
GSK Investigational Site
Barcelona, , Spain
GSK Investigational Site
Barcelona, , Spain
GSK Investigational Site
Bilbao, , Spain
GSK Investigational Site
Elche, , Spain
GSK Investigational Site
La Laguna-Tenerife, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Murcia, , Spain
GSK Investigational Site
Palma de Mallorca, , Spain
GSK Investigational Site
Sant Boi de Llobregat, , Spain
GSK Investigational Site
Valencia, , Spain
GSK Investigational Site
Vigo, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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212483
Identifier Type: -
Identifier Source: org_study_id