Safety and Efficacy of Dolutegravir/Lamivudine (DTG/3TC) in Therapy-naive Human Immunodeficiency Virus-1 (HIV-1) Infected Adolescents

An Open-label, Single Arm Study to Evaluate the Week 48 Efficacy and Safety of a Two-drug Regimen of Dolutegravir/Lamivudine (DTG/3TC) as a Fixed Dose Combination (FDC), in Antiretroviral Therapy (ART)-Naive HIV-1-infected Adolescents, ≥12 to <18 Years of Age Who Weigh at Least 25 kg

First-line antiretroviral regimens are highly efficacious and generally well tolerated. However, as these regimens need to be taken life-long, there is growing concern about long-term toxicities associated with these regimens. Thus, there is great interest from participants and clinicians in unique regimens that might avoid such toxicities by minimizing the number of antiretrovirals without sacrificing long-term antiviral efficacy. DTG plus 3TC is a novel, well-tolerated first-line regimen for HIV-infected treatment- naive participants, limiting the risk of many common adverse reactions associated with other antiretroviral drugs. Thus, this study is designed to evaluate the efficacy and safety of DTG/3TC as a FDC, in ART-naive HIV-1-infected adolescents, who weigh at least 25 kilograms (kg). The study will consists of Screening Phase (up to 28 days prior to the first dose of drug) followed by Treatment Phase (up to 48 weeks). Participants who successfully complete 48 weeks of therapy and who continue to receive benefit from DTG/3TC FDC may enter a 96 weeks study Extension Phase. Study participants who have successfully completed both the Treatment Phase through 48 weeks and the Extension Phase through 144 weeks and continue to receive benefit from this two-drug regimen will continue to receive DTG/3TC FDC in a Continuation Phase (after Week 144) until: DTG and 3TC are both locally approved for use as part of a dual regimen and the single entities of DTG and 3TC are available to participants (e.g. through public health services), or the DTG/3TC FDC tablet, if required by local regulations, is locally approved and available (e.g. commercially or through public health services), or the participant no longer derives clinical benefit or the participant meets a protocol-defined reason for discontinuation. All participants will receive the FDC of DTG/3TC (50/300 milligrams) for once daily. Approximately 30 participants will be enrolled in the study.

Study Overview

• Status: Active, not recruiting
• Conditions: HIV Infections
• Intervention / Treatment: Drug: DTG + 3TC FDC

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 3

Contacts and Locations

Study Locations

• Kenya
  • Kericho, Kenya, 20200
    • GSK Investigational Site
  • Kisumu, Kenya, 40100
    • GSK Investigational Site
• South Africa
  • Congella, Durban, South Africa, 4052
    • GSK Investigational Site
  • Parow Valley, South Africa, 7505
    • GSK Investigational Site
  • Soweto, South Africa, 2013
    • GSK Investigational Site
• Thailand
  • Bangkok, Thailand, 10330
    • GSK Investigational Site
  • Bangkoknoi, Thailand, 10700
    • GSK Investigational Site
  • Chiang Mai, Thailand, 50200
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 15 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• HIV-1 infected adolescents >=12 to <18 years of age at the time of signing the informed consent form.
• Weight >=25 kg at the time of signing the informed consent form.
• Screening plasma HIV-1 RNA between 1,000 and <=500,000 c/mL.
• Antiretroviral-naive (defined as no prior therapy with any antiretroviral agent for the treatment of HIV following a diagnosis of HIV-1 infection). Participants who received ART for prevention of mother to child transmission of HIV in the first 3 months of life are allowed. Participants who received HIV post-exposure prophylaxis (PEP) or pre-exposure prophylaxis (PrEP) in the past are allowed as long as the last PEP/PrEP dose was >6 months from HIV diagnosis or there is documented HIV seronegativity at least 2 months after the last prophylactic dose and prior to the date of HIV diagnosis.
• Male and female participants will be included. A female participant is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotrophin [hCG] test at Screening and negative urine hCG test before Enrollment) and not lactating. Female participants who are of child bearing potential and who are engaging in sexual activity that could lead to pregnancy, must agree to use one of the birth control method from 28 days prior to the first dose of study medication, and until 4 weeks after the last dose of study medication (and completion of the follow-up visit). Condoms are recommended in addition, because their appropriate use is the only contraception method effective for preventing HIV-1 transmission. The investigator is responsible for ensuring that participants understand how to properly use these methods of contraception. All participants participating in the study should also be counselled on safer sexual practices, including the use and benefit/risk of effective barrier methods (example given [e.g.] male condom), and on the risk of HIV transmission to an uninfected partner.
• The participant's parent(s) or legal guardian or the participant is capable of giving signed informed consent.

Exclusion Criteria:

• Females who are breastfeeding or plan to become pregnant or breastfeed during the study.
• Any evidence of an active Centers for Disease Control and Prevention (CDC) Stage 3 and/or Category C or World Health Organization (WHO) Stage 4 disease, except cutaneous Kaposi's sarcoma not requiring systemic therapy and historical or current CD4 cell counts less than 200 cells per cubic millimeter (cells/mm^3) or CD4 percent <15 percent.
• Participants with severe hepatic impairment (Class C) as determined by Child-Pugh classification.
• Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
• Evidence of hepatitis B virus (HBV) infection based on the results of testing at Screening for HBV surface antigen (HBsAg), HBV core antibody (anti-HBc), HBV surface antibody (anti-HBs or HBsAb), and HBV Deoxyribonucleic acid (DNA) as follows: participants positive for HBsAg are excluded; participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded. Participant's positive for anti-HBc (negative HBsAg status) and positive for anti-HBs (past and/or current evidence) are immune to HBV and are not excluded.
• Anticipated need for any HCV therapy during the first 48 weeks of the study and for HCV therapy based on interferon or any drugs that have a potential for adverse drug: drug interactions with study treatment throughout the entire study period.
• Untreated syphilis infection (positive rapid plasma reagin [RPR] at Screening without clear documentation of treatment). Participants who are at least 24 hours post completed treatment are eligible.
• History or sensitivity to any of the study medications 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 participation.
• 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; other localized malignancies require agreement between the investigator and the Study Medical Monitor for inclusion of the participant.
• Participants who in the investigator's judgment, poses a significant suicidality risk. Recent history of suicidal behavior and/or suicidal ideation may be considered as evidence of serious suicide risk.
• 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.
• Treatment with any agent with documented activity against HIV-1 in vitro within 28 days of first dose of study treatment.
• Receipt of any prohibited medication and inability or unwillingness to switch to an alternative medication.
• Exposure to an experimental drug or experimental vaccine within either 28 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 the first dose of study treatment.
• Any evidence of pre-existing viral resistance based on the presence of any major resistance-associated mutation in the Screening result or, if known, in any historical resistance test result.
• Any verified Grade 4 laboratory abnormality. A single repeat test is allowed during the Screening period to verify a result.
• Any acute laboratory abnormality at Screening, which, in the opinion of the Investigator, would preclude the participant's participation in the study of an investigational compound.
• ALT >=5 times the upper limit of normal (ULN) or ALT >=3 times ULN and bilirubin >=1.5 times ULN (with >35 percent direct bilirubin).
• Creatinine clearance of <50 milliliters per minute per 1.73 square meter (mL/min/1.73 m^2) using the Schwartz equation method.
• Children who are wards of the state or government.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Participants receiving DTG + 3TC FDC; Eligible participants will receive FDC of DTG + 3TC 50/300 milligrams, tablets, given orally once daily.	Drug: DTG + 3TC FDC; DTG + 3TC FDC will be available as 50/300 milligrams tablet to be given orally once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Less Than 50 Copies Per Milliliter (c/mL) at Week 48	Percentage of participants with plasma HIV-1 RNA <50 c/mL was assessed at Week 48 according to the Food and Drug Administration (FDA) snapshot algorithm.	Week 48

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Plasma HIV-1 RNA <200 c/mL at Week 24	Percentage of participants with plasma HIV-1 RNA <200 c/mL was assessed at Week 24 according to the FDA snapshot algorithm.	Week 24
Percentage of Participants With Plasma HIV-1 RNA <200 c/mL at Week 96	Percentage of participants with plasma HIV-1 RNA <200 c/mL will be assessed at Week 96 according to the FDA snapshot algorithm.	Week 96
Percentage of Participants With Plasma HIV-1 RNA <200 c/mL at Week 144	Percentage of participants with plasma HIV-1 RNA <200 c/mL will be assessed at Week 144 according to the FDA snapshot algorithm.	Week 144
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 24	Percentage of participants with plasma HIV-1 RNA <50 c/mL was assessed at Week 24 according to the FDA snapshot algorithm.	Week 24
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 96	Percentage of participants with plasma HIV-1 RNA <50 c/mL will be assessed at Week 96 according to the FDA snapshot algorithm.	Week 96
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 144	Percentage of participants with plasma HIV-1 RNA <50 c/mL will be assessed at Week 144 according to the FDA Snapshot algorithm.	Week 144
Percentage of Participants With Plasma HIV-1 RNA <200 c/mL at Week 48	Percentage of participants with plasma HIV-1 RNA <200 c/mL was assessed at Week 48 according to the FDA snapshot algorithm.	Week 48
Number of Participants With Adverse Events and Serious Adverse Events Through 144 Weeks	An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A serious adverse event is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment.	Up to 144 weeks
Number of Participants With Severity of Adverse Events Through 144 Weeks	An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. The Division of acquired immunodeficiency syndrome (AIDS) table for grading the severity of adult and pediatric adverse events will be used to assess severity.	Up to 144 weeks
Number of Participants With Abnormal Findings for Hematology Parameters Through 144 Weeks	Blood samples will be collected from participants for analysis of hematology parameters including platelet counts, red blood cell counts, neutrophils, white blood cell counts, lymphocytes, hemoglobin, monocytes, hematocrit, eosinophils, mean corpuscular volume, basophils, and mean corpuscular hemoglobin.	Up to 144 weeks
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks	Blood samples will be collected from participants for analysis of clinical chemistry parameters including blood urea nitrogen, potassium, aspartate aminotransferase, total bilirubin, creatinine, chloride, alanine aminotransferase (ALT), albumin, glucose, total carbon dioxide, alkaline phosphatase, creatine phosphokinase, sodium, phosphate, glomerular filtration rate/ creatinine clearance, calcium, protein and cystatin-C.	Up to 144 weeks
Number of Participants With Abnormal Findings for Fasting Lipids Through 144 Weeks	Lipid assessments including total cholesterol, high density lipoprotein cholesterol, low density lipoprotein cholesterol and triglycerides will be performed.	Up to 144 weeks
Number of Participants With Abnormal Findings for Urinalysis Parameters Through 144 Weeks	Urine samples will be collected from participants for the analysis of urinalysis parameters including specific gravity, potential of hydrogen (pH) of urine, presence of glucose, protein, blood and ketones in urine by dipstick test along with urine albumin/creatinine ratio, urine protein/creatinine ratio and urine phosphate.	Up to 144 weeks
Number of Participants Who Discontinue Treatment Due to Adverse Events Through 144 Weeks	An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment.	Up to 144 weeks
Number of Participants With Adverse Events and Serious Adverse Events Through 96 Weeks	An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A serious adverse event is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment.	Up to 96 weeks
Number of Participants With Severity of Adverse Events Through 96 Weeks	An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs will be evaluated by the investigator and graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms.	Up to 96 weeks
Number of Participants With Abnormal Findings for Hematology Parameters Through 96 Weeks	Blood samples will be collected from participants for analysis of hematology parameters including platelet counts, red blood cell counts, neutrophils, white blood cell counts, lymphocytes, hemoglobin, monocytes, hematocrit, eosinophils, mean corpuscular volume, basophils, and mean corpuscular hemoglobin.	Up to 96 weeks
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks	Blood samples will be collected from participants for analysis of clinical chemistry parameters including blood urea nitrogen, potassium, aspartate aminotransferase, total bilirubin, creatinine, chloride, ALT, albumin, glucose, total carbon dioxide, alkaline phosphatase, creatine phosphokinase, sodium, phosphate, glomerular filtration rate/ creatinine clearance, calcium, protein and cystatin-C.	Up to 96 weeks
Number of Participants With Abnormal Findings for Fasting Lipids Through 96 Weeks	Lipid assessments including total cholesterol, high density lipoprotein cholesterol, low density lipoprotein cholesterol and triglycerides will be performed.	Up to 96 weeks
Number of Participants With Abnormal Findings for Urinalysis Parameters Through 96 Weeks	Urine samples will be collected from participants for the analysis of urinalysis parameters including specific gravity, pH of urine, presence of glucose, protein, blood and ketones in urine by dipstick test along with urine albumin/creatinine ratio, urine protein/creatinine ratio and urine phosphate.	Up to 96 weeks
Number of Participants Undergoing Viral Load Monitoring From Week 48 Through 144 Weeks	Viral load monitoring of participants will be performed from Week 48 through 144 weeks	Week 48 and up to Week 144
Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Count at Week 24	CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Baseline value is defined as the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Lymphocyte subsets were collected for assessment of this outcome measure by flow cytometry.	Baseline (Day 1) and Week 24
Change From Baseline in CD4+ Cell Count at Week 48	CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Baseline value is defined as the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Lymphocyte subsets were collected for assessment of this outcome measure by flow cytometry.	Baseline (Day 1) and Week 48
Change From Baseline in CD8+ Cell Count at Week 24	CD8+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Baseline value is defined as the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Lymphocyte subsets were collected for assessment of this outcome measure by flow cytometry.	Baseline (Day 1) and Week 24
Change From Baseline in CD8+ Cell Count at Week 48	CD8+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Baseline value is defined as the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Lymphocyte subsets were collected for assessment of this outcome measure by flow cytometry.	Baseline (Day 1) and Week 48
Change From Baseline in Ratio of CD4+ and CD8+ at Week 24	CD4+/CD8+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Baseline value is defined as the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Lymphocyte subsets were collected for assessment of this outcome measure by flow cytometry.	Baseline (Day 1) and Week 24
Change From Baseline in Ratio of CD4+ and CD8+ at Week 48	CD4+/CD8+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Baseline value is defined as the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Lymphocyte subsets were collected for assessment of this outcome measure by flow cytometry.	Baseline (Day 1) and Week 48
Number of Participants With Disease Progression From Week 24 Through Week 48	Participants with disease progression included incidences of HIV-associated conditions, Acquired Immuno Deficiency Syndrome (AIDS) and death. HIV-associated conditions were assessed according to the 2014 HIV infection by Centers for Disease Control and Prevention (CDC) classification system for HIV Infection in adults to evaluate the immune effects of DTG /3TC FDC.	Week 24 and up to Week 48
Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) From Week 24 Through Week 48	An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A serious adverse event is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment.	Week 24 and up to Week 48
Number of Participants With Severity of Adverse Events From Week 24 Through Week 48	An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were evaluated by the investigator and graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms.	Week 24 and up to Week 48
Number of Participants With Abnormal Findings for Hematology Parameters From Week 24 Through Week 48	Blood samples were collected from participants for analysis of hematology parameters including Hemoglobin (HGB), White Blood Cells (WBCs) and Neutrophils (NPs). The abnormal findings were graded based on severity as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Life threatening).	Week 24 and up to Week 48
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48	Blood samples were collected from participants for analysis of clinical chemistry parameters including blood urea Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Bilirubin (BIL), Calcium (Ca), Carbon Dioxide (CO2), Creatine Kinase (CK), Creatinine (CR), Glomerular Filtration Rate [GFR] from Creatinine Adjusted for Body Surface Area [BSA] (GRF/CR-BSA), Glucose (Glu), Potassium (K) and Sodium (Na). The abnormal findings were graded based on severity as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Life threatening).	Week 24 and up to Week 48
Number of Participants With Abnormal Findings for Fasting Lipids From Week 24 Through Week 48	Lipid assessments including total cholesterol (TC), low density lipoprotein cholesterol (LDLC) and triglycerides (TGs) was performed. The abnormal findings were graded based on severity as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Life threatening).	Week 24 and up to Week 48
Number of Participants With Abnormal Findings for Urinalysis Parameters From Week 24 Through Week 48	Urine samples were collected from participants, for the analysis of urinalysis parameters including the presence of glucose and protein in urine, by dipstick test. The abnormal findings were graded based on severity as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Life threatening).	Week 24 and up to Week 48
Number of Participants Who Discontinued Treatment Due to Adverse Events From Week 24 Through Week 48	An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment.	Week 24 and up to Week 48
Maximum Observed Plasma Concentration (Cmax) Following Dosing With DTG and 3TC	Blood samples were collected on a subset of participants for intensive pharmacokinetic analysis.	Pre-dose, 0.5, 1.0, 1.5, 2, 3, 4, 6, 10, and 24 hours post-dose at Week 1
Time of Maximum Observed Plasma Concentration (Tmax) Following Dosing With DTG and 3TC	Blood samples were collected on a subset of participants for intensive pharmacokinetic analysis.	Pre-dose, 0.5, 1.0, 1.5, 2, 3, 4, 6, 10, and 24 hours post-dose at Week 1
Area Under the Plasma Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC[0-t]) Following Dosing With DTG and 3TC	Blood samples were collected on a subset of participants for intensive pharmacokinetic analysis.	Pre-dose, 0.5, 1.0, 1.5, 2, 3, 4, 6, 10, and 24 hours post-dose at Week 1
Area Under the Curve (AUC) Over the Dosing Interval (AUC[0-tau]) Following Dosing With DTG and 3TC	Blood samples were collected on a subset of participants for intensive pharmacokinetic analysis.	Pre-dose, 0.5, 1.0, 1.5, 2, 3, 4, 6, 10, and 24 hours post-dose at Week 1
Apparent Terminal Half-life (t1/2) Following Dosing With DTG and 3TC	Blood samples were collected on a subset of participants for intensive pharmacokinetic analysis.	Pre-dose, 0.5, 1.0, 1.5, 2, 3, 4, 6, 10, and 24 hours post-dose at Week 1
Observed Pre-dose Concentration Following Dosing With DTG and 3TC	Blood samples were collected on a subset of participants for intensive pharmacokinetic analysis.	Pre-dose at Week 1
Observed Plasma Concentration at 24 Hours Following Dosing With DTG and 3TC	Blood samples were collected on a subset of participants for intensive pharmacokinetic analysis.	24 hours post-dose at Week 1
Number of Participants With Observed Genotypic Resistance to DTG and 3TC	Genotypic resistance to DTG and 3TC in participants with protocol-defined virologic failure will be assessed.	Up to 144 weeks
Number of Participants With Observed Phenotypic Resistance to DTG and 3TC	Phenotypic resistance to DTG and 3TC in participants with protocol-defined virologic failure will be assessed.	Up to 144 weeks

Collaborators and Investigators

• Sponsor: ViiV Healthcare
• Investigators: Study Director: GSK Clinical Trials, ViiV Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2019
• Primary Completion (Actual): December 1, 2021
• Study Completion (Estimated): February 23, 2024

Study Registration Dates

• First Submitted: September 21, 2018
• First Submitted That Met QC Criteria: September 21, 2018
• First Posted (Actual): September 25, 2018

Study Record Updates

• Last Update Posted (Estimated): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: HIV-1; Lamivudine; Dolutegravir; Viral load; Fixed dose combination; DOVATO
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Urogenital Diseases; Genital Diseases; HIV Infections
• Other Study ID Numbers: 205861

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
• IPD Sharing Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No