Clinical Trials

MainTitle

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

This study has been suspended
Sponsor
ViiV Healthcare


Information provided by (Responsible Party)
ViiV Healthcare
ClinicalTrials.gov Identifier
NCT03682848

First received: September 21, 2018
Last updated: April 15, 2020
Last Verified: April 2020
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
HIV Infections

Drug : DTG + 3TC FDC
Phase 3

Study Type: Interventional
Study Design: Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All participants will receive the FDC of DTG/3TC (50/300 milligrams) for once daily dosing in this single arm study.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by ViiV Healthcare:

Primary Outcome Measures

  • Proportion of participants with plasma HIV-1 ribonucleic acid (RNA) less than 50 copies per milliliter (c/mL) at Week 48 [ Time Frame: Week 48 ]
    Proportion of participants with plasma HIV-1 RNA <50 c/mL in the intent to treat-exposed (ITT-E) population will be assessed at Week 48 according to the Food and Drug Administration (FDA) Snapshot algorithm.
Secondary Outcome Measures:
  • Proportion of participants with plasma HIV-1 RNA <200 c/mL at Week 24 [ Time Frame: Week 24 ]
    Proportion of participants with plasma HIV-1 RNA <200 c/mL in the ITT-E population will be assessed at Week 24 according to the FDA's Snapshot algorithm.
  • Proportion of participants with plasma HIV-1 RNA <200 c/mL at Week 96 [ Time Frame: Week 96 ]
    Proportion of participants with plasma HIV-1 RNA <200 c/mL in the ITT-E population will be assessed at Week 96 according to the FDA's Snapshot algorithm.
  • Proportion of participants with plasma HIV-1 RNA <200 c/mL at Week 144 [ Time Frame: Week 144 ]
    Proportion of participants with plasma HIV-1 RNA <200 c/mL in the ITT-E population will be assessed at Week 144 according to the FDA's Snapshot algorithm.
  • Proportion of participants with plasma HIV-1 RNA <50 c/mL at Week 24 [ Time Frame: Week 24 ]
    Proportion of participants with plasma HIV-1 RNA <50 c/mL in the ITT-E population will be assessed at Week 24 according to the FDA's Snapshot algorithm.
  • Proportion of participants with plasma HIV-1 RNA <50 c/mL at Week 96 [ Time Frame: Week 96 ]
    Proportion of participants with plasma HIV-1 RNA <50 c/mL in the ITT-E population will be assessed at Week 96 according to the FDA's Snapshot algorithm.
  • Proportion of participants with plasma HIV-1 RNA <50 c/mL at Week 144 [ Time Frame: Week 144 ]
    Proportion of participants with plasma HIV-1 RNA <50 c/mL in the ITT-E population will be assessed at Week 144 according to the FDA's Snapshot algorithm.
  • Proportion of participants with plasma HIV-1 RNA <200 c/mL at Week 48 [ Time Frame: Week 48 ]
    Proportion of participants with plasma HIV-1 RNA <200 c/mL in the ITT-E population will be assessed at Week 48 according to the FDA's Snapshot algorithm.
  • Number of participants with adverse events and serious adverse events through 144 weeks [ Time Frame: Up to 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.
  • Number of participants with severity of adverse events through 144 weeks [ Time Frame: Up to 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.
  • Number of participants with abnormal findings for hematology parameters through 144 weeks [ Time Frame: Up to 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.
  • Number of participants with abnormal findings for clinical chemistry parameters through 144 weeks [ Time Frame: Up to 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.
  • Number of participants with abnormal findings for fasting lipids through 144 weeks [ Time Frame: Up to 144 weeks ]
    Lipid assessments including total cholesterol, high density lipoprotein cholesterol, low density lipoprotein cholesterol and triglycerides will be performed.
  • Number of participants with abnormal findings for urinalysis parameters through 144 weeks [ Time Frame: Up to 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.
  • Number of participants who discontinue treatment due to adverse events through 144 weeks [ Time Frame: Up to 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.
  • Number of participants with adverse events and serious adverse events through 96 weeks [ Time Frame: Up to 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.
  • Number of participants with severity of adverse events through 96 weeks [ Time Frame: Up to 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. The Division of AIDS table for grading the severity of adult and pediatric adverse events will be used to assess severity.
  • Number of participants with abnormal findings for hematology parameters through 96 weeks [ Time Frame: Up to 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.
  • Number of participants with abnormal findings for clinical chemistry parameters through 96 weeks [ Time Frame: Up to 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.
  • Number of participants with abnormal findings for fasting lipids through 96 weeks [ Time Frame: Up to 96 weeks ]
    Lipid assessments including total cholesterol, high density lipoprotein cholesterol, low density lipoprotein cholesterol and triglycerides will be performed.
  • Number of participants with abnormal findings for urinalysis parameters through 96 weeks [ Time Frame: Up to 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.
  • Number of participants undergoing viral load monitoring from Week 48 through 144 weeks [ Time Frame: Week 48 and up to 144 weeks ]
    Viral load monitoring of participants will be performed.
  • Change from Baseline in cluster of differentiation 4+ (CD4+) cell count at Week 24 [ Time Frame: Baseline and Week 24 ]
    Lymphocyte subsets including CD4+ cell counts will be collected for assessment by flow cytometry.
  • Change from Baseline in CD4+ cell count at Week 48 [ Time Frame: Baseline and Week 48 ]
    Lymphocyte subsets including CD4+ cell counts will be collected for assessment by flow cytometry.
  • Change from Baseline in CD8+ cell count at Week 24 [ Time Frame: Baseline and Week 24 ]
    Lymphocyte subsets including CD8+ cell counts will be collected for assessment by flow cytometry.
  • Change from Baseline in CD8+ cell count at Week 48 [ Time Frame: Baseline and Week 48 ]
    Lymphocyte subsets including CD8+ cell counts will be collected for assessment by flow cytometry.
  • Change from Baseline in ratio of CD4+ and CD8+ at Week 24 [ Time Frame: Baseline and Week 24 ]
    The ratio of CD4+ cells to CD8+ cells will be assessed.
  • Change from Baseline in ratio of CD4+ and CD8+ at Week 48 [ Time Frame: Baseline and Week 48 ]
    The ratio of CD4+ cells to CD8+ cells will be assessed.
  • Number of participants with disease progression from Week 24 through 48 weeks [ Time Frame: Week 24 and up to 48 weeks ]
    The number of participants with disease progression including HIV-associated conditions, AIDS, and death will be assessed.
  • Number of participants with adverse events and serious adverse events from Week 24 through 48 weeks [ Time Frame: Week 24 and up to 48 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.
  • Number of participants with severity of adverse events from Week 24 through 48 weeks [ Time Frame: Week 24 and up to 48 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 AIDS table for grading the severity of adult and pediatric adverse events will be used to assess severity.
  • Number of participants with abnormal findings for hematology parameters from Week 24 through 48 weeks [ Time Frame: Week 24 and up to 48 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.
  • Number of participants with abnormal findings for clinical chemistry parameters from Week 24 through 48 weeks [ Time Frame: Week 24 and up to 48 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.
  • Number of participants with abnormal findings for fasting lipids from Week 24 through 48 weeks [ Time Frame: Week 24 and up to 48 weeks ]
    Lipid assessments including total cholesterol, high density lipoprotein cholesterol, low density lipoprotein cholesterol and triglycerides will be performed.
  • Number of participants with abnormal findings for urinalysis parameters from Week 24 through 48 weeks [ Time Frame: Week 24 and up to 48 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.
  • Number of participants who discontinue treatment due to adverse events from Week 24 through 48 weeks [ Time Frame: Week 24 and up to 48 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.
  • Maximum observed plasma concentration (Cmax) following dosing with DTG and 3TC [ Time Frame: Pre-dose, 0.5, 1.0, 1.5, 2, 3, 4, 6, 10, and 24 hours post-dose on Day 5 and Day 10 ]
    Blood samples will be collected on a subset of participants for intensive pharmacokinetic analysis.
  • Time of maximum observed plasma concentration (tmax) following dosing with DTG and 3TC [ Time Frame: Pre-dose, 0.5, 1.0, 1.5, 2, 3, 4, 6, 10, and 24 hours post-dose on Day 5 and Day 10 ]
    Blood samples will be collected on a subset of participants for intensive pharmacokinetic analysis.
  • 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 [ Time Frame: Pre-dose, 0.5, 1.0, 1.5, 2, 3, 4, 6, 10, and 24 hours post-dose on Day 5 and Day 10 ]
    Blood samples will be collected on a subset of participants for intensive pharmacokinetic analysis.
  • Area under the curve (AUC) over the dosing interval (AUC[0-tau]] following dosing with DTG and 3TC [ Time Frame: Pre-dose, 0.5, 1.0, 1.5, 2, 3, 4, 6, 10, and 24 hours post-dose on Day 5 and Day 10 ]
    Blood samples will be collected on a subset of participants for intensive pharmacokinetic analysis.
  • Apparent terminal half-life (t1/2) following dosing with DTG and 3TC [ Time Frame: Pre-dose, 0.5, 1.0, 1.5, 2, 3, 4, 6, 10, and 24 hours post-dose on Day 5 and Day 10 ]
    Blood samples will be collected on a subset of participants for intensive pharmacokinetic analysis.
  • Observed pre-dose (trough) concentration (C0) following dosing with DTG and 3TC [ Time Frame: Pre-dose, 0.5, 1.0, 1.5, 2, 3, 4, 6, 10, and 24 hours post-dose on Day 5 and Day 10 ]
    Blood samples will be collected on a subset of participants for intensive pharmacokinetic analysis.
  • Observed plasma concentration at the end of 24 hours of dosing interval (C24) following dosing with DTG and 3TC [ Time Frame: Pre-dose, 0.5, 1.0, 1.5, 2, 3, 4, 6, 10, and 24 hours post-dose on Day 5 and Day 10 ]
    Blood samples will be collected on a subset of participants for intensive pharmacokinetic analysis.
  • Number of participants with observed genotypic resistance to DTG and 3TC [ Time Frame: Up to 144 weeks ]
    Genotypic resistance to DTG and 3TC in participants with protocol-defined virologic failure will be assessed.
  • Number of participants with observed phenotypic resistance to DTG and 3TC [ Time Frame: Up to 144 weeks ]
    Phenotypic resistance to DTG and 3TC in participants with protocol-defined virologic failure will be assessed.

Estimated Enrollment: 30
Study Start Date: April 9, 2019
Estimated Study Completion Date: March 30, 2026
Estimated Primary Completion Date: May 31, 2021 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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.

Eligibility

Eligibility

Ages Eligible for Study: 12 Years to 17 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03682848

Locations

United States, Florida
GSK Investigational Site
Jacksonville, Florida, United States, 32209
United States, Tennessee
GSK Investigational Site
Memphis, Tennessee, United States, 38105-3678
Kenya
GSK Investigational Site
Kisumu, Kenya, 40100
South Africa
GSK Investigational Site
Congella, Durban, South Africa, 4052
GSK Investigational Site
Parow Valley, South Africa, 7505
GSK Investigational Site
Soweto, South Africa, 2013
Thailand
GSK Investigational Site
Bangkoknoi, Thailand, 10700
GSK Investigational Site
Bangkok, Thailand, 10330
GSK Investigational Site
Chiang Mai, Thailand, 50200

Sponsors and Collaborators

ViiV Healthcare

Investigators

Study Director: GSK Clinical Trials ViiV Healthcare
More Information

More Information


Responsible Party: ViiV Healthcare  
ClinicalTrials.gov Identifier: NCT03682848   History of Changes  
Other Study ID Numbers: 205861  
Study First Received: September 21, 2018  
Last Updated: April 15, 2020  
Individual Participant Data    
Plan to Share IPD: Yes  

Studies a U.S. FDA-regulated Drug Product: Yes  
Studies a U.S. FDA-regulated Device Product: No  

Keywords provided by ViiV Healthcare:

Viral load
Dolutegravir
Lamivudine
HIV-1
Fixed dose combination
DOVATO

Additional relevant MeSH terms:
HIV Infections

ClinicalTrials.gov processed this data on June 02, 2020
This information is provided by ClinicalTrials.gov.