A Study to Evaluate the Efficacy, Safety, and Tolerability of Using an Oral Once-daily 2 Drug Regimen Compared to an Oral Once-daily 3 Drug Regimen for the Treatment of Human Immunodeficiency Virus (HIV)-1 in Adults Who Have Not Previously Taken Antiretroviral Therapy
NCT ID: NCT05979311
Last Updated: 2025-12-05
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
PHASE3
Total Enrollment
473 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-02-09
Study Completion Date
2027-02-23
Brief Summary
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This study will compare safety, efficacy, participant reported outcomes and implementation outcomes of a fixed dose combination (FDC) of a two-drug regimen dolutegravir (DTG) plus lamivudine (3TC) and a three-drug regimen FDC of bictegravir (BIC), emtricitabine (FTC) and tenofovir alafenamide (TAF) in HIV-1 infected adult participants who have not previously received antiretroviral therapy.
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An Efficacy, Safety, and Tolerability Study Comparing Dolutegravir Plus Lamivudine With Dolutegravir Plus Tenofovir/Emtricitabine in Treatment naïve HIV Infected Subjects (Gemini 1)
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Detailed Description
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Conditions
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HIV
HIV Infections
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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DTG/3TC
Participants will receive FDC of DTG/3TC once daily until Week 96.
Group Type
EXPERIMENTAL
Dolutegravir
Intervention Type
DRUG
Dolutegravir will be administered once daily.
Lamivudine
Intervention Type
DRUG
Lamivudine will be administered once daily.
BIC/FTC/TAF
Participants will receive BIC/FTC/TAF once daily until Week 96.
Group Type
ACTIVE_COMPARATOR
Bictegravir
Intervention Type
DRUG
Bictegravir will be administered once daily.
Emtricitabine
Intervention Type
DRUG
Emtricitabine will be administered once daily.
Tenofovir alafenamide
Intervention Type
DRUG
Tenofovir alafenamide will be administered once daily.
Interventions
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Dolutegravir
Dolutegravir will be administered once daily.
Intervention Type
DRUG
Lamivudine
Lamivudine will be administered once daily.
Intervention Type
DRUG
Bictegravir
Bictegravir will be administered once daily.
Intervention Type
DRUG
Emtricitabine
Emtricitabine will be administered once daily.
Intervention Type
DRUG
Tenofovir alafenamide
Tenofovir alafenamide will be administered once daily.
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* Participants with age \>=18 years (or older, if required by local regulations) at the time of obtaining informed consent.
* An individual participant is eligible to participate if they are not pregnant (as confirmed by a negative serum human chorionic gonadotropin (hCG) test at Screening and a negative urine hCG test at Enrollment) and not lactating.
* Antiretroviral-naïve (no prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection) person living with HIV.
* Participant (or participant's legally acceptable representative \[LAR\]) is capable of giving written informed consent.
* Eligible participants or their LAR must sign a written Informed Consent Form before any protocol-specified assessments are conducted. Enrollment of participants who are unable to provide direct informed consent is optional and will be based on local legal/regulatory requirements and site feasibility to conduct protocol procedures.
* Participants enrolled in France must be affiliated to, or a beneficiary of, a social security category.
* An individual participant is eligible to participate if they are not pregnant (as confirmed by a negative serum human chorionic gonadotropin (hCG) test at Screening and a negative urine hCG test at Enrollment) and not lactating.
* Antiretroviral-naïve (no prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection) person living with HIV.
* Participant (or participant's legally acceptable representative \[LAR\]) is capable of giving written informed consent.
* Eligible participants or their LAR must sign a written Informed Consent Form before any protocol-specified assessments are conducted. Enrollment of participants who are unable to provide direct informed consent is optional and will be based on local legal/regulatory requirements and site feasibility to conduct protocol procedures.
* Participants enrolled in France must be affiliated to, or a beneficiary of, a social security category.
Exclusion Criteria
* Individuals who are pregnant or breastfeeding or plan to become pregnant or breastfeed during the study.
* Any evidence of a current Centers for Disease Control and Prevention (CDC) Stage 3 disease; with the exception of cutaneous Kaposi's sarcoma not requiring systemic therapy, and CD4+ count \<200 cells per cubic millimeter (neither is exclusionary).
* History or presence of allergy or intolerance to the study drugs or their components or drugs of their class, or a history of drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates study participation.
* Ongoing or clinically relevant pancreatitis.
* Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia; other localized malignancies require agreement between the Investigator and the Medical Monitor for inclusion of the participant prior to enrollment.
* Participants with severe hepatic impairment (Class C) as determined by Child-Pugh classification.
* 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 liver cirrhosis with or without hepatitis viral co-infection.
* Alanine aminotransferase (ALT) \>=5 times the upper limit of normal (ULN) or ALT \>=3\*ULN and bilirubin \>=1.5\*ULN (with \>35% direct bilirubin).
* Participants determined by the Investigator to have a high risk of seizures, including participants with an unstable or poorly controlled seizure disorder. A participant with a prior history of seizure may be considered for enrollment if the Investigator believes the risk of seizure recurrence is low. All cases of prior seizure history should be discussed with the Medical Monitor prior to enrollment.
* Participants who, in the investigator's judgment, pose a significant suicide risk. Participant's recent history of suicidal behavior and/or suicidal ideation should be considered when evaluating for suicide risk.
* Signs and symptoms which, in the opinion of the Investigator, are suggestive of active Coronavirus disease 2019 (COVID-19) (example fever, cough) infection within 14 days prior to enrollment.
* Evidence of Hepatitis B virus (HBV) infection based on the results of central lab testing at Screening for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb), Hepatitis B surface antibody (HBsAb) and HBV Deoxyribonucleic Acid (DNA) as follows:
a. Participants positive for HBsAg are excluded; b. Participants negative for HBsAb and negative for HBsAg but positive for hepatitis B core antibody (HBcAb) may be excluded based on the following consideration: i. Exclude if HBV DNA is detected \[either \<Lower Limit of Quantification (LLoQ), \>Upper Limit of Quantification (ULoQ) OR numerical value (i.e., between LLoQ and ULoQ)\] ii. Not excluded if HBV DNA is negative, not detected
* Participants with Hepatitis C virus (HCV) co-infection at Screening are eligible only if:
i. liver enzymes meet entry criteria; and ii. HCV disease is not anticipated to require on-study treatment with any agent(s) that have potential adverse drug-drug interactions (DDIs) with the study interventions; and iii. HCV disease has undergone appropriate work-up and is not advanced and will not require treatment prior to the primary endpoint or later visit. Additional information on participants with HCV co-infection at screening should include results from any liver biopsy, Fibroscan, ultrasound, or other fibrosis evaluation, history of cirrhosis or other decompensated liver disease, prior treatment, and timing/plan for HCV treatment.
iv. In the event that recent biopsy or imaging data is not available or inconclusive, the Fib-4 score will be used to verify eligibility
1. Fib-4 score \>3.25 is exclusionary;
2. Fib-4 scores 1.45 - 3.25 requires Medical Monitor consultation.
Fibrosis 4 score Formula:
(Age \* Aspartate aminotransferase \[AST\]) / (Platelets \* (square root of ALT)
* Untreated syphilis infection (positive rapid plasma reagin \[RPR\] at Screening without clear documentation of treatment) are excluded. Participants with a false positive RPR (with negative treponemal test) or serofast RPR result (persistence of a reactive nontreponemal syphilis test despite history of adequate therapy and no evidence of re-exposure) may enroll after consultation with the Medical Monitor. Participants who completed treatment at least 7 days prior to Screening are eligible.
* Presence of any major resistance-associated mutations as defined by the International Antiviral Society-United States of America (IAS-USA) resistance guidelines to DTG, 3TC, BIC, FTC or TAF in the Screening result.
* Exposure to an experimental drug or experimental vaccine within either 30 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent (whichever is longer), prior to first dose of study treatment.
* Treatment with any of the following agents within 28 days of Screening:
i. radiation therapy; ii. cytotoxic chemotherapeutic agents; iii. tuberculosis therapy with the exception of isoniazid (isonicotinylhydrazid, INH); iv. immunomodulators that alter immune responses such as chronic systemic corticosteroids, interleukins, or interferons.
* Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening.
* Treatment with any agent with documented activity against HIV-1 in vitro within 28 days of first dose of study treatment. Treatment withacyclovir/valacyclovir is permitted.
* Participants receiving any protocol-defined prohibited medication and who are unwilling or unable to switch to an alternate medication.
* Any verified Grade 4 laboratory abnormality, with the exception of Grade 4 lipid abnormalities.
* Any acute laboratory abnormality at Screening, which, in the opinion of the investigator, would preclude the participant's participation in an interventional clinical trial.
* Participant has estimated creatine clearance \<30 milliliter per minute (mL/min) per 1.73 square meter using the refitted, race-neutral Chronic Kidney Disease Epidemiology Collaboration (CKD-EPIcr\_R) method.
* Participants known or suspected to have acquired HIV-1 concurrent with use of Pre-exposure prophylaxis (PrEP) or Post-exposure prophylaxis (PEP) must be discussed with the Medical Monitor prior to enrollment.
* Any condition which, in the opinion of the Investigator, may interfere with the absorption, distribution, metabolism or excretion of the study drugs or render the participant unable to receive study medication.
* Any pre-existing physical or mental condition (including substance use disorder) which, in the opinion of the Investigator, may interfere with the participant's ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participant.
* Participant is currently participating in, or anticipates being selected for, any other interventional study.
* Any evidence of a current Centers for Disease Control and Prevention (CDC) Stage 3 disease; with the exception of cutaneous Kaposi's sarcoma not requiring systemic therapy, and CD4+ count \<200 cells per cubic millimeter (neither is exclusionary).
* History or presence of allergy or intolerance to the study drugs or their components or drugs of their class, or a history of drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates study participation.
* Ongoing or clinically relevant pancreatitis.
* Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia; other localized malignancies require agreement between the Investigator and the Medical Monitor for inclusion of the participant prior to enrollment.
* Participants with severe hepatic impairment (Class C) as determined by Child-Pugh classification.
* 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 liver cirrhosis with or without hepatitis viral co-infection.
* Alanine aminotransferase (ALT) \>=5 times the upper limit of normal (ULN) or ALT \>=3\*ULN and bilirubin \>=1.5\*ULN (with \>35% direct bilirubin).
* Participants determined by the Investigator to have a high risk of seizures, including participants with an unstable or poorly controlled seizure disorder. A participant with a prior history of seizure may be considered for enrollment if the Investigator believes the risk of seizure recurrence is low. All cases of prior seizure history should be discussed with the Medical Monitor prior to enrollment.
* Participants who, in the investigator's judgment, pose a significant suicide risk. Participant's recent history of suicidal behavior and/or suicidal ideation should be considered when evaluating for suicide risk.
* Signs and symptoms which, in the opinion of the Investigator, are suggestive of active Coronavirus disease 2019 (COVID-19) (example fever, cough) infection within 14 days prior to enrollment.
* Evidence of Hepatitis B virus (HBV) infection based on the results of central lab testing at Screening for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb), Hepatitis B surface antibody (HBsAb) and HBV Deoxyribonucleic Acid (DNA) as follows:
a. Participants positive for HBsAg are excluded; b. Participants negative for HBsAb and negative for HBsAg but positive for hepatitis B core antibody (HBcAb) may be excluded based on the following consideration: i. Exclude if HBV DNA is detected \[either \<Lower Limit of Quantification (LLoQ), \>Upper Limit of Quantification (ULoQ) OR numerical value (i.e., between LLoQ and ULoQ)\] ii. Not excluded if HBV DNA is negative, not detected
* Participants with Hepatitis C virus (HCV) co-infection at Screening are eligible only if:
i. liver enzymes meet entry criteria; and ii. HCV disease is not anticipated to require on-study treatment with any agent(s) that have potential adverse drug-drug interactions (DDIs) with the study interventions; and iii. HCV disease has undergone appropriate work-up and is not advanced and will not require treatment prior to the primary endpoint or later visit. Additional information on participants with HCV co-infection at screening should include results from any liver biopsy, Fibroscan, ultrasound, or other fibrosis evaluation, history of cirrhosis or other decompensated liver disease, prior treatment, and timing/plan for HCV treatment.
iv. In the event that recent biopsy or imaging data is not available or inconclusive, the Fib-4 score will be used to verify eligibility
1. Fib-4 score \>3.25 is exclusionary;
2. Fib-4 scores 1.45 - 3.25 requires Medical Monitor consultation.
Fibrosis 4 score Formula:
(Age \* Aspartate aminotransferase \[AST\]) / (Platelets \* (square root of ALT)
* Untreated syphilis infection (positive rapid plasma reagin \[RPR\] at Screening without clear documentation of treatment) are excluded. Participants with a false positive RPR (with negative treponemal test) or serofast RPR result (persistence of a reactive nontreponemal syphilis test despite history of adequate therapy and no evidence of re-exposure) may enroll after consultation with the Medical Monitor. Participants who completed treatment at least 7 days prior to Screening are eligible.
* Presence of any major resistance-associated mutations as defined by the International Antiviral Society-United States of America (IAS-USA) resistance guidelines to DTG, 3TC, BIC, FTC or TAF in the Screening result.
* Exposure to an experimental drug or experimental vaccine within either 30 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent (whichever is longer), prior to first dose of study treatment.
* Treatment with any of the following agents within 28 days of Screening:
i. radiation therapy; ii. cytotoxic chemotherapeutic agents; iii. tuberculosis therapy with the exception of isoniazid (isonicotinylhydrazid, INH); iv. immunomodulators that alter immune responses such as chronic systemic corticosteroids, interleukins, or interferons.
* Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening.
* Treatment with any agent with documented activity against HIV-1 in vitro within 28 days of first dose of study treatment. Treatment withacyclovir/valacyclovir is permitted.
* Participants receiving any protocol-defined prohibited medication and who are unwilling or unable to switch to an alternate medication.
* Any verified Grade 4 laboratory abnormality, with the exception of Grade 4 lipid abnormalities.
* Any acute laboratory abnormality at Screening, which, in the opinion of the investigator, would preclude the participant's participation in an interventional clinical trial.
* Participant has estimated creatine clearance \<30 milliliter per minute (mL/min) per 1.73 square meter using the refitted, race-neutral Chronic Kidney Disease Epidemiology Collaboration (CKD-EPIcr\_R) method.
* Participants known or suspected to have acquired HIV-1 concurrent with use of Pre-exposure prophylaxis (PrEP) or Post-exposure prophylaxis (PEP) must be discussed with the Medical Monitor prior to enrollment.
* Any condition which, in the opinion of the Investigator, may interfere with the absorption, distribution, metabolism or excretion of the study drugs or render the participant unable to receive study medication.
* Any pre-existing physical or mental condition (including substance use disorder) which, in the opinion of the Investigator, may interfere with the participant's ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participant.
* Participant is currently participating in, or anticipates being selected for, any other interventional study.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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ViiV Healthcare
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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GSK Investigational Site
Ciudad Autonoma de Buenos Aire, , Argentina
Site Status
GSK Investigational Site
Córdoba, , Argentina
Site Status
GSK Investigational Site
Antwerp, , Belgium
Site Status
GSK Investigational Site
Brussels, , Belgium
Site Status
GSK Investigational Site
Ghent, , Belgium
Site Status
GSK Investigational Site
Hvidovre, , Denmark
Site Status
GSK Investigational Site
Bordeaux, , France
Site Status
GSK Investigational Site
Bordeaux, , France
Site Status
GSK Investigational Site
Lyon, , France
Site Status
GSK Investigational Site
Montpellier, , France
Site Status
GSK Investigational Site
Nice, , France
Site Status
GSK Investigational Site
Nîmes, , France
Site Status
GSK Investigational Site
Paris, , France
Site Status
GSK Investigational Site
Paris, , France
Site Status
GSK Investigational Site
Paris, , France
Site Status
GSK Investigational Site
Paris, , France
Site Status
GSK Investigational Site
Berlin, , Germany
Site Status
GSK Investigational Site
Cologne, , Germany
Site Status
GSK Investigational Site
Frankfurt, , Germany
Site Status
GSK Investigational Site
Hamburg, , Germany
Site Status
GSK Investigational Site
München, , Germany
Site Status
GSK Investigational Site
Athens, , Greece
Site Status
GSK Investigational Site
Athens, , Greece
Site Status
GSK Investigational Site
Thessaloniki, , Greece
Site Status
GSK Investigational Site
Dublin, , Ireland
Site Status
GSK Investigational Site
Dublin, , Ireland
Site Status
GSK Investigational Site
Haifa, , Israel
Site Status
GSK Investigational Site
Ramat Gan, , Israel
Site Status
GSK Investigational Site
Rehovot, , Israel
Site Status
GSK Investigational Site
Tel Aviv, , Israel
Site Status
GSK Investigational Site
Bari, , Italy
Site Status
GSK Investigational Site
Bergamo, , Italy
Site Status
GSK Investigational Site
Padua, , Italy
Site Status
GSK Investigational Site
Pavia, , Italy
Site Status
GSK Investigational Site
Sassari, , Italy
Site Status
GSK Investigational Site
Aichi, , Japan
Site Status
GSK Investigational Site
Osaka, , Japan
Site Status
GSK Investigational Site
Tokyo, , Japan
Site Status
GSK Investigational Site
Tokyo, , Japan
Site Status
GSK Investigational Site
Mérida, , Mexico
Site Status
GSK Investigational Site
Bydgoszcz, , Poland
Site Status
GSK Investigational Site
Lodz, , Poland
Site Status
GSK Investigational Site
Wroclaw, , Poland
Site Status
GSK Investigational Site
Aveiro, , Portugal
Site Status
GSK Investigational Site
Porto, , Portugal
Site Status
GSK Investigational Site
Badalona, , Spain
Site Status
GSK Investigational Site
Barcelona, , Spain
Site Status
GSK Investigational Site
Elche Alicante, , Spain
Site Status
GSK Investigational Site
La Laguna-Tenerife, , Spain
Site Status
GSK Investigational Site
Madrid, , Spain
Site Status
GSK Investigational Site
Madrid, , Spain
Site Status
GSK Investigational Site
Madrid, , Spain
Site Status
GSK Investigational Site
Marbella, , Spain
Site Status
GSK Investigational Site
Palma de Mallorca, , Spain
Site Status
GSK Investigational Site
Palma de Mallorca, , Spain
Site Status
GSK Investigational Site
Valencia, , Spain
Site Status
GSK Investigational Site
Stockholm, , Sweden
Site Status
GSK Investigational Site
Basel, , Switzerland
Site Status
GSK Investigational Site
Zurich, , Switzerland
Site Status
GSK Investigational Site
Glasgow, , United Kingdom
Site Status
GSK Investigational Site
London, , United Kingdom
Site Status
GSK Investigational Site
London, , United Kingdom
Site Status
GSK Investigational Site
London, , United Kingdom
Site Status
GSK Investigational Site
London, , United Kingdom
Site Status
Countries
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Argentina
Belgium
Denmark
France
Germany
Greece
Ireland
Israel
Italy
Japan
Mexico
Poland
Portugal
Spain
Sweden
Switzerland
United Kingdom
Other Identifiers
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219816
Identifier Type: -
Identifier Source: org_study_id
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