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Early initiation of antiretroviral therapy (ART) reduces morbidity and mortality for individuals infected with HIV. Suppressing viral replication with ART also reduces the potential for transmission of HIV. Hence, ART is recommended for all persons with HIV viremia regardless of cluster of differentiation 4 (CD4) count. This is an open-label single arm which will evaluate the feasibility, efficacy and safety using a fixed dose combination (FDC) of Dolutegravir (DTG) plus Lamivudine (3TC) as a first line regimen of a rapid Test and Treat model of care over 48 weeks. Participants with new and confirmed diagnosed HIV-1 who are willing to start study treatment immediately following diagnosis will receive 50 milligram (mg) DTG + 300 (mg) 3TC FDC as first line therapy without waiting for screening laboratory results, at the Screening/Day 1 Visit. The total duration for the study will be 52 weeks and 4 weeks of follow up period if required. This study will be conducted in United States (US) with approximately 120 participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants receiving Dolutegravir + Lamivudine FDC | Experimental | Participants will receive DTG 50mg and 3TC 300 mg FDC tablet orally once daily (OD) with or without food |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dolutegravir + Lamivudine FDC | Drug | Dolutegravir + Lamivudine FDC is available as white oval film-coated tablets which are packed in high density polyethylene (HDPE) bottles with induction seals and child-resistant closures. Each 60 milliliter (mL) bottle contains 30 tablets |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) Regardless of Antiretroviral Therapy (ART) Regimen at Week 24 by ITT-E Missing = Failure Analysis | Participants were classified as "HIV-1 RNA <50 c/mL" using an ITT-E missing = Failure analysis. Participants were classified as 'HIV-1 RNA < 50 c/mL' if the last viral load within the Week 24 visit window was <50/c/mL, regardless of the ART regimen they were on at the time of viral load assessment (in other words switch from DTG plus 3TC fixed-dose combination [FDC] to another ART was not penalized) and as HIV-1 RNA >= 50 c/mL in all other cases (i.e. last viral load within Week 24 visit window >= 50 c/mL, on study but having missing viral load data at Week 24, discontinued early from study due to lost to follow-up (LFU), withdrew consent or any other reason). Confidence intervals (CI) were calculated based on the Exact Clopper-Pearson method. Percentage of participants with plasma HIV-1 RNA < 50 c/mL based on ITT-E missing = Failure analysis at Week 24 are presented. | At Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Plasma HIV-1 RNA <50 c/mL Regardless of ART Regimen at Week 48 by ITT-E Missing = Failure Analysis | Participants were classified as "HIV-1 RNA <50 c/mL" using an ITT-E Missing = Failure analysis. Participants were classified as 'HIV-1 RNA < 50 c/mL' if the last viral load within the Week 48 visit window was <50/c/mL, regardless of the ART regimen they were on at the time of viral load assessment (in other words switch from DTG plus 3TC FDC to another ART was not penalized) and as HIV-1 RNA >= 50 c/mL in all other cases (i.e. last viral load within Week 48 visit window >= 50 c/mL, on study but having missing viral load data at Week 48, discontinued early from study due to LFU, withdrew consent or any other reason). CI were calculated based on the Exact Clopper-Pearson method. Percentage of participants with plasma HIV-1 RNA < 50 c/mL based on ITT-E missing = Failure analysis at Week 48 are presented. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With HIV-1 RNA < 50 c/mL at Weeks 24 and 48 Among Participants With Available HIV-1 RNA Assessment Regardless of ART | Participants with at least one viral load assessment within Week 24 and 48 visit window have been considered. Participants who discontinued from study prior to Week 24 and Week 48 or who were still on study at Week 24 and Week 48 but with missing viral load assessment have been excluded. Viral load assessments performed under DTG + 3TC FDC treatment or under any Modified ART treatment at Week 24 and Week 48 have been considered. Percentage of participants with HIV-1 RNA < 50 c/mL at Weeks 24 and 48 among participants with available HIV-1 RNA assessment regardless of ART have been presented. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | ViiV Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35294 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34115650 | Background | Rolle CP, Berhe M, Singh T, Ortiz R, Wurapa A, Ramgopal M, Leone PA, Matthews JE, Dalessandro M, Underwood MR, Angelis K, Wynne BR, Merrill D, Nguyen C, van Wyk J, Zolopa AR. Dolutegravir/lamivudine as a first-line regimen in a test-and-treat setting for newly diagnosed people living with HIV. AIDS. 2021 Oct 1;35(12):1957-1965. doi: 10.1097/QAD.0000000000002979. | |
| 40134635 |
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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 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.
A total of 133 participants were screened and 131 participants were enrolled in the study.
This was an open-label single arm study to evaluate the feasibility, efficacy and safety of a rapid Test and Treat intervention in newly diagnosed human immunodeficiency viruses (HIV)-1 infected adults using a fixed dose combination of dolutegravir (DTG) plus lamivudine (3TC) as a first line regimen.
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| ID | Title | Description |
|---|---|---|
| FG000 | DTG Plus 3TC | Participants received DTG 50 milligram (mg) and 3TC 300 mg fixed dose combination tablet orally once daily with or without food. |
| 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 | Jun 6, 2019 | Mar 23, 2021 |
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Participants will receive 50 mg DTG + 300 mg 3TC FDC, participants will administer one tablet once daily (OD) orally with or without food.
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| At Week 48 |
| Percentage of Participants With Plasma HIV-1 RNA <50 c/mL Using Food and Drug Administration (FDA) Snapshot Algorithm | Percentage of participants with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (either due to missing plasma HIV-1 RNA assessment but on study, or due to permanent discontinuation of study treatment prior to visit window) as virologic non-success, as well as participants who switched from first line regimen of DTG + 3TC FDC for any reason prior to the visit of interest. Confidence intervals were calculated based on the Exact Clopper-Pearson method. Percentage of participants with plasma HIV-1 RNA <50 c/mL obtained using FDA Snapshot algorithm are presented. | At Week 24 and Week 48 |
| Time to Viral Suppression (HIV-1 RNA<50 c/mL) for Participants Who Had HIV-1 RNA >= 50 c/mL at Baseline | Time of viral suppression for participants who had HIV-1 RNA >= 50 c/mL at Baseline is defined as the time to first viral load value < 50 c/mL, irrespective of the ART regimen a participant was on when that occurred. Non parametric Kaplan-Meier method was used. Participants who withdrew for any reason without being suppressed were censored at date of withdrawal. Participants who have not been withdrawn and have not had viral suppression at time of the analysis were censored at last viral load date. Median time (i.e. time when 50% of participants have reached HIV-1 RNA < 50 c/mL) along with 95% CI is presented. | Up to Week 48 |
| Number of Participants Who Changed First Line Regimen of DTG + 3TC FDC Due to Baseline Laboratory Results or HIV-1 Resistance Mutation Results | Number of participants who switched from first line regimen of DTG + 3TC FDC due to abnormal Baseline laboratory values or Baseline HIV-1 resistance mutation results are presented. | Up to Week 48 |
| Number of Participants With Treatment-emergent Genotypic Resistance | Blood samples were collected for genotypic resistance testing post-Baseline when Confirmed Virologic Failure criteria were met or in other occasion as needed (e.g. at time of study withdrawal when HIV-1 RNA >= 400 c/mL). New mutations were tabulated by drug class: integrase strand transfer inhibitor (INSTI), non-nucleoside reverse transcriptase inhibitor (NNRTI), nucleoside reverse transcriptase inhibitor (NRTI) and protease inhibitor (PI). Number of participants with treatment-emergent resistance associated mutations to any class (INSTI, NNRTI, NRTI, PI) from post-Baseline genotypic resistance data up to Week 48 have been presented. | Up to Week 48 |
| Number of Participants With Treatment-emergent Phenotypic Resistance | Blood samples were collected for drug resistance testing post-Baseline when Confirmed Virologic Failure criteria were met or in other occasion as needed (e.g. at time of study withdrawal when HIV-1 RNA >= 400 c/mL). Assessment of antiviral activity of ART using phenotypic test results was interpreted through a proprietary algorithm (from Monogram Biosciences) and provides the overall susceptibility of the drug. Number of participants with phenotypic resistance to DTG and/or 3TC or any other ART (if treatment is modified) taken during the study in participants with post-Baseline phenotypic resistance data up to Week 48 have been presented. | Up to Week 48 |
| Number of Participants With Any Serious Adverse Events (SAEs) and Any Common (>=2%) Non-serious Adverse Events (Non-SAEs) Under Treatment With DTG + 3TC FDC | An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations as judged by physician. Number of participants with any SAE and common (>=2%) non-SAEs are presented. | Up to Week 48 |
| Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Under Treatment With DTG + 3TC FDC | Blood samples were collected up to Week 48 visit for the analysis of hematology parameters-platelet count, neutrophils, hemoglobin and leukocytes Any abnormality was graded according to Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). Higher grade indicates more severity. Only those participants with maximum post-Baseline emergent hematology toxicities in any of the hematology parameters have been presented. | Up to Week 48 |
| Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC | Blood samples were collected up to Week 48 for the analysis of clinical chemistry parameters: alanine aminotransferase (ALT), albumin, aspartate aminotransferase (AST), Alkaline Phosphatase (ALP), bilirubin, carbon dioxide (CO2), creatinine kinase (CK), creatinine, glomerular filtration rate (GFR) from creatinine adjusted for body surface area (BSA), glucose, hypercalcemia, hyperkalemia, hypernatremia, hypocalcemia, hypokalemia, hyponatremia and phosphate. Any abnormality was graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). Higher grade indicates more severity. Only those participants with maximum post-Baseline emergent chemistry toxicities in any of the chemistry parameters have been presented. | Up to Week 48 |
| Number of Participants Who Discontinued the Study Treatment (DTG+3TC FDC) Due to AEs | An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants who discontinued the study treatment (DTG plus 3TC) due to AEs are presented. | Up to Week 48 |
| Number of Participants Who Discontinued the Study Treatment (DTG+3TC FDC) Due to Drug-related AEs | An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants who discontinued the study treatment (DTG+3TC FDC) due to drug-related AEs are presented. | Up to Week 48 |
| Change From Baseline in Cluster of Differentiation (CD4+) Cell Counts for Participants Under Treatment With DTG + 3TC FDC | CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells decline. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline (Day 1) and Week 24 and Week 48 |
| Change From Baseline in CD4+/CD8+ Cell Count Ratio for Participants Under Treatment With DTG + 3TC FDC | Blood samples were collected at specified time points to assess CD4+/CD8+ cell count ratio. It was assessed by flow cyclometry to evaluate the immunologic activity of DTG plus 3TC. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline (Day 1) and Week 24 and Week 48 |
| Number of Participants With HIV-1 Disease Progression to Stage 3 HIV-associated Conditions, Acquired Immunodeficiency Syndrome (AIDS) or Death (for Participants Under Treatment With DTG + 3TC FDC) | HIV-associated conditions were recorded during the study and was assessed according to the 2014 Centers for Disease Control and Prevention (CDC) Classification System for HIV Infection in Adults. CDC classification for HIV were stage 1, 2 and 3. Higher stage indicates more severity. Disease progression summarize participants who had HIV infection stage 3 associated conditions, AIDS and/or death. Number of participants with HIV-1 disease progression to stage 3 HIV-associated conditions, AIDS or death are presented. | Up to Week 48 |
| Number of Participants Who Completed 24 and 48 Weeks on Study | Number of participants who completed 24 and 48 weeks on study are presented. | Week 24 and Week 48 |
| Number of Participants Retained in Care for 24 and 48 Weeks on Study and Have HIV-1 RNA <200 c/mL | Number of participants retained in care for 24 and 48 weeks on study and have HIV-1 RNA <200 c/mL have been presented. | Week 24 and Week 48 |
| At Week 24 and Week 48 |
| Los Angeles |
| California |
| 90036 |
| United States |
| GSK Investigational Site | Palm Springs | California | 92262 | United States |
| GSK Investigational Site | Ft. Pierce | Florida | 34982 | United States |
| GSK Investigational Site | Miami | Florida | 33136 | United States |
| GSK Investigational Site | Oakland Park | Florida | 33334 | United States |
| GSK Investigational Site | Orlando | Florida | 32803 | United States |
| GSK Investigational Site | Orlando | Florida | 32806 | United States |
| GSK Investigational Site | Decatur | Georgia | 30030 | United States |
| GSK Investigational Site | Savannah | Georgia | 31405 | United States |
| GSK Investigational Site | Minneapolis | Minnesota | 55415 | United States |
| GSK Investigational Site | St Louis | Missouri | 63108 | United States |
| GSK Investigational Site | Huntersville | North Carolina | 28078 | United States |
| GSK Investigational Site | Austin | Texas | 78705 | United States |
| GSK Investigational Site | Bellaire | Texas | 77401 | United States |
| GSK Investigational Site | Dallas | Texas | 75246 | United States |
| Rolle CP, Arribas JR, Ortiz R, Underwood M, Parry CM, Grove R, DiMondi VP, Jones B, Kisare M. Efficacy and Safety Outcomes in Adults Initiating Dolutegravir/Lamivudine With High Viral Load in the GEMINI-1/-2 and STAT Trials. Open Forum Infect Dis. 2025 Mar 7;12(3):ofaf135. doi: 10.1093/ofid/ofaf135. eCollection 2025 Mar. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | DTG Plus 3TC | Participants received DTG 50 milligram (mg) and 3TC 300 mg fixed dose combination tablet orally once daily with or without food. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex/Gender, Customized | Number | Participants |
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| Race/Ethnicity, Customized | Number | 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 Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) Regardless of Antiretroviral Therapy (ART) Regimen at Week 24 by ITT-E Missing = Failure Analysis | Participants were classified as "HIV-1 RNA <50 c/mL" using an ITT-E missing = Failure analysis. Participants were classified as 'HIV-1 RNA < 50 c/mL' if the last viral load within the Week 24 visit window was <50/c/mL, regardless of the ART regimen they were on at the time of viral load assessment (in other words switch from DTG plus 3TC fixed-dose combination [FDC] to another ART was not penalized) and as HIV-1 RNA >= 50 c/mL in all other cases (i.e. last viral load within Week 24 visit window >= 50 c/mL, on study but having missing viral load data at Week 24, discontinued early from study due to lost to follow-up (LFU), withdrew consent or any other reason). Confidence intervals (CI) were calculated based on the Exact Clopper-Pearson method. Percentage of participants with plasma HIV-1 RNA < 50 c/mL based on ITT-E missing = Failure analysis at Week 24 are presented. | Intent-To-Treat Exposed (ITT-E) Population was used which comprised of all enrolled participants who received at least one dose of study treatment. ITT-E missing = Failure analysis is mentioned as 'Observed analysis' in the protocol. | 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 Regardless of ART Regimen at Week 48 by ITT-E Missing = Failure Analysis | Participants were classified as "HIV-1 RNA <50 c/mL" using an ITT-E Missing = Failure analysis. Participants were classified as 'HIV-1 RNA < 50 c/mL' if the last viral load within the Week 48 visit window was <50/c/mL, regardless of the ART regimen they were on at the time of viral load assessment (in other words switch from DTG plus 3TC FDC to another ART was not penalized) and as HIV-1 RNA >= 50 c/mL in all other cases (i.e. last viral load within Week 48 visit window >= 50 c/mL, on study but having missing viral load data at Week 48, discontinued early from study due to LFU, withdrew consent or any other reason). CI were calculated based on the Exact Clopper-Pearson method. Percentage of participants with plasma HIV-1 RNA < 50 c/mL based on ITT-E missing = Failure analysis at Week 48 are presented. | Intent-to-Treat Exposed Population | Posted | Number | 95% Confidence Interval | Percentage of Participants | At Week 48 |
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| Other Pre-specified | Percentage of Participants With HIV-1 RNA < 50 c/mL at Weeks 24 and 48 Among Participants With Available HIV-1 RNA Assessment Regardless of ART | Participants with at least one viral load assessment within Week 24 and 48 visit window have been considered. Participants who discontinued from study prior to Week 24 and Week 48 or who were still on study at Week 24 and Week 48 but with missing viral load assessment have been excluded. Viral load assessments performed under DTG + 3TC FDC treatment or under any Modified ART treatment at Week 24 and Week 48 have been considered. Percentage of participants with HIV-1 RNA < 50 c/mL at Weeks 24 and 48 among participants with available HIV-1 RNA assessment regardless of ART have been presented. | Intent-to-Treat Exposed Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Posted | Number | Percentage of Participants | At Week 24 and Week 48 |
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| Secondary | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL Using Food and Drug Administration (FDA) Snapshot Algorithm | Percentage of participants with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (either due to missing plasma HIV-1 RNA assessment but on study, or due to permanent discontinuation of study treatment prior to visit window) as virologic non-success, as well as participants who switched from first line regimen of DTG + 3TC FDC for any reason prior to the visit of interest. Confidence intervals were calculated based on the Exact Clopper-Pearson method. Percentage of participants with plasma HIV-1 RNA <50 c/mL obtained using FDA Snapshot algorithm are presented. | Intent-to-Treat Exposed Population | Posted | Number | 95% Confidence Interval | Percentage of Participants | At Week 24 and Week 48 |
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| Secondary | Time to Viral Suppression (HIV-1 RNA<50 c/mL) for Participants Who Had HIV-1 RNA >= 50 c/mL at Baseline | Time of viral suppression for participants who had HIV-1 RNA >= 50 c/mL at Baseline is defined as the time to first viral load value < 50 c/mL, irrespective of the ART regimen a participant was on when that occurred. Non parametric Kaplan-Meier method was used. Participants who withdrew for any reason without being suppressed were censored at date of withdrawal. Participants who have not been withdrawn and have not had viral suppression at time of the analysis were censored at last viral load date. Median time (i.e. time when 50% of participants have reached HIV-1 RNA < 50 c/mL) along with 95% CI is presented. | Intent-to-Treat Exposed Population. Only those participants with data available at the specified time points were analyzed. | Posted | Median | 95% Confidence Interval | Days | Up to Week 48 |
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| Secondary | Number of Participants Who Changed First Line Regimen of DTG + 3TC FDC Due to Baseline Laboratory Results or HIV-1 Resistance Mutation Results | Number of participants who switched from first line regimen of DTG + 3TC FDC due to abnormal Baseline laboratory values or Baseline HIV-1 resistance mutation results are presented. | Intent-to-Treat Exposed Population | Posted | Count of Participants | Participants | Up to Week 48 |
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| Secondary | Number of Participants With Treatment-emergent Genotypic Resistance | Blood samples were collected for genotypic resistance testing post-Baseline when Confirmed Virologic Failure criteria were met or in other occasion as needed (e.g. at time of study withdrawal when HIV-1 RNA >= 400 c/mL). New mutations were tabulated by drug class: integrase strand transfer inhibitor (INSTI), non-nucleoside reverse transcriptase inhibitor (NNRTI), nucleoside reverse transcriptase inhibitor (NRTI) and protease inhibitor (PI). Number of participants with treatment-emergent resistance associated mutations to any class (INSTI, NNRTI, NRTI, PI) from post-Baseline genotypic resistance data up to Week 48 have been presented. | HIV-1 Viral Genotypic Population comprised of all participants in the ITT-E Population who had available post-Baseline HIV-1 genotypic resistance data either for DTG + 3TC FDC or any other ART. Only those participants with data available at the specified time points were analyzed. | Posted | Count of Participants | Participants | Up to Week 48 |
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| Secondary | Number of Participants With Treatment-emergent Phenotypic Resistance | Blood samples were collected for drug resistance testing post-Baseline when Confirmed Virologic Failure criteria were met or in other occasion as needed (e.g. at time of study withdrawal when HIV-1 RNA >= 400 c/mL). Assessment of antiviral activity of ART using phenotypic test results was interpreted through a proprietary algorithm (from Monogram Biosciences) and provides the overall susceptibility of the drug. Number of participants with phenotypic resistance to DTG and/or 3TC or any other ART (if treatment is modified) taken during the study in participants with post-Baseline phenotypic resistance data up to Week 48 have been presented. | HIV-1 Viral Phenotypic Population comprised of all participants in the ITT-E Population who had available post-Baseline HIV-1 phenotypic resistance data either under treatment with DTG + 3TC FDC or any other ART. Only those participants with data available at the specified time points were analyzed. | Posted | Count of Participants | Participants | Up to Week 48 |
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| Secondary | Number of Participants With Any Serious Adverse Events (SAEs) and Any Common (>=2%) Non-serious Adverse Events (Non-SAEs) Under Treatment With DTG + 3TC FDC | An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations as judged by physician. Number of participants with any SAE and common (>=2%) non-SAEs are presented. | Safety Population comprised of all enrolled participants who received at least one dose of study treatment. | Posted | Count of Participants | Participants | Up to Week 48 |
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| Secondary | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Under Treatment With DTG + 3TC FDC | Blood samples were collected up to Week 48 visit for the analysis of hematology parameters-platelet count, neutrophils, hemoglobin and leukocytes Any abnormality was graded according to Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). Higher grade indicates more severity. Only those participants with maximum post-Baseline emergent hematology toxicities in any of the hematology parameters have been presented. | Safety Population | Posted | Count of Participants | Participants | Up to Week 48 |
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| Secondary | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC | Blood samples were collected up to Week 48 for the analysis of clinical chemistry parameters: alanine aminotransferase (ALT), albumin, aspartate aminotransferase (AST), Alkaline Phosphatase (ALP), bilirubin, carbon dioxide (CO2), creatinine kinase (CK), creatinine, glomerular filtration rate (GFR) from creatinine adjusted for body surface area (BSA), glucose, hypercalcemia, hyperkalemia, hypernatremia, hypocalcemia, hypokalemia, hyponatremia and phosphate. Any abnormality was graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). Higher grade indicates more severity. Only those participants with maximum post-Baseline emergent chemistry toxicities in any of the chemistry parameters have been presented. | Safety Population | Posted | Count of Participants | Participants | Up to Week 48 |
|
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| Secondary | Number of Participants Who Discontinued the Study Treatment (DTG+3TC FDC) Due to AEs | An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants who discontinued the study treatment (DTG plus 3TC) due to AEs are presented. | Safety Population | Posted | Count of Participants | Participants | Up to Week 48 |
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| Secondary | Number of Participants Who Discontinued the Study Treatment (DTG+3TC FDC) Due to Drug-related AEs | An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants who discontinued the study treatment (DTG+3TC FDC) due to drug-related AEs are presented. | Safety Population | Posted | Count of Participants | Participants | Up to Week 48 |
|
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline in Cluster of Differentiation (CD4+) Cell Counts for Participants Under Treatment With DTG + 3TC FDC | CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells decline. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. | Intent-to-Treat Exposed Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Posted | Mean | Standard Deviation | Cells per cubic millimeter | Baseline (Day 1) and Week 24 and Week 48 |
|
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| Secondary | Change From Baseline in CD4+/CD8+ Cell Count Ratio for Participants Under Treatment With DTG + 3TC FDC | Blood samples were collected at specified time points to assess CD4+/CD8+ cell count ratio. It was assessed by flow cyclometry to evaluate the immunologic activity of DTG plus 3TC. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. | Intent-to-Treat Exposed Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Posted | Mean | Standard Deviation | Ratio | Baseline (Day 1) and Week 24 and Week 48 |
|
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| Secondary | Number of Participants With HIV-1 Disease Progression to Stage 3 HIV-associated Conditions, Acquired Immunodeficiency Syndrome (AIDS) or Death (for Participants Under Treatment With DTG + 3TC FDC) | HIV-associated conditions were recorded during the study and was assessed according to the 2014 Centers for Disease Control and Prevention (CDC) Classification System for HIV Infection in Adults. CDC classification for HIV were stage 1, 2 and 3. Higher stage indicates more severity. Disease progression summarize participants who had HIV infection stage 3 associated conditions, AIDS and/or death. Number of participants with HIV-1 disease progression to stage 3 HIV-associated conditions, AIDS or death are presented. | Intent-to-Treat Exposed Population | Posted | Count of Participants | Participants | Up to Week 48 |
|
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| Secondary | Number of Participants Who Completed 24 and 48 Weeks on Study | Number of participants who completed 24 and 48 weeks on study are presented. | Intent-to-Treat Exposed Population | Posted | Count of Participants | Participants | Week 24 and Week 48 |
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| Secondary | Number of Participants Retained in Care for 24 and 48 Weeks on Study and Have HIV-1 RNA <200 c/mL | Number of participants retained in care for 24 and 48 weeks on study and have HIV-1 RNA <200 c/mL have been presented. | Intent-to-Treat Exposed Population | Posted | Count of Participants | Participants | Week 24 and Week 48 |
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Serious adverse events (SAEs) and non-serious adverse events were collected from start of study treatment (Week 1) up to end of the study (Week 48).
SAEs and non-serious adverse events were reported for the Safety Population which comprised of all enrolled participants who received at least one dose of study treatment.
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 | DTG Plus 3TC | Participants received DTG 50 milligram (mg) and 3TC 300 mg fixed dose combination tablet orally once daily with or without food. | 0 | 131 | 2 | 131 | 85 | 131 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Streptococcal bacteraemia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Chlamydial infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Gonorrhoea | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Exposure to communicable disease | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Anogenital dysplasia | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Proctitis gonococcal | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Anal chlamydia infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Oropharyngeal gonococcal infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Anogenital warts | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 23.1 | 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 Reponse Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 20, 2019 | Mar 23, 2021 | SAP_001.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 |
|---|---|
| C562325 | dolutegravir |
Not provided
Not provided
Not provided
| Transgender Female |
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| African American/African (Afr.) Heritage (Her.) |
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| Native Hawaiian or other Pacific Islander |
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| White/Caucasian/European Heritage |
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| Afr.Amer./Afr. Her. and Amer. Ind. or Ala. Native |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Week 24 |
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| Week 48 |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Week 24 |
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| Week 48 |
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