HIV InfectionsPhase 3NCT03682848
Safety and Efficacy of Dolutegravir/Lamivudine (DTG/3TC) in Therapy-naive Human Immunodeficiency Virus-1 (HIV-1) Infected Adolescents
A Phase 3 study testing DTG + 3TC FDC in people with HIV Infections, run by ViiV Healthcare at 8 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- DTG + 3TC FDC
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 6 May 2019to 22 May 2025
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- HIV-1-infected adolescents were 12 to <18 years of age at the time of signing the informed consent form.
- Weight was >25 kg at the time of signing the informed consent form.
- Screening plasma HIV-1 RNA was between 1,000 and =500,000 c/mL.
- Participants were antiretroviral-naive (defined as having had no prior therapy with any antiretroviral agent for the treatment of HIV following a diagnosis of HIV-1 infection). Participants who had received ART for prevention of mother-to-child transmission of HIV in the first 3 months of life were allowed. Participants who had received HIV post-exposure prophylaxis (PEP) or pre-exposure prophylaxis (PrEP) in the past were allowed as long as the last PEP/PrEP dose was = 6 months before HIV diagnosis or there was documented HIV seronegativity at least 2 months after the last prophylactic dose and prior to the date of HIV diagnosis.
- Male and female participants were included. A female participant was eligible to participate if she was not pregnant (as confirmed by a negative serum human chorionic gonadotropin [hCG] test at Screening and a negative urine hCG test before Enrollment) and not lactating. Female participants of child-bearing potential who were engaging in sexual activity that could have led to pregnancy had to agree to use one birth-control method from 28 days prior to the first dose of study medication until 4 weeks after the last dose of study medication (and completion of the follow-up visit). Condoms were additionally recommended, as appropriate use was the only contraceptive method effective in preventing HIV-1 transmission. The investigator was responsible for ensuring that participants understood how to properly use these contraceptive methods. All participants in the study were also counseled on safer sexual practices, including the use and benefit/risk of effective barrier methods (e.g., male condoms), as well as on the risk of HIV transmission to an uninfected partner.
- The participant's parent(s) or legal guardian, or the participant, was capable of giving signed informed consent.
Who cannot join
- Females who were breastfeeding or who planned to become pregnant or breastfeed during the study were excluded.
- Any evidence of 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 <200 cells/mm³ or CD4 percent <15 percent resulted in exclusion.
- Participants with severe hepatic impairment (Class C) as determined by the Child-Pugh classification were excluded.
- Participants with unstable liver disease (defined by ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, or known biliary abnormalities (except Gilbert's syndrome or asymptomatic gallstones) were excluded.
- Evidence of hepatitis B virus (HBV) infection at Screening led to exclusion as follows: participants positive for HBsAg were excluded; participants negative for anti-HBs but positive for anti-HBc (negative HBsAg) and positive for HBV DNA were excluded. Participants positive for anti-HBc (negative HBsAg) and anti-HBs (past and/or current evidence) were immune to HBV and were not excluded.
- Participants with an anticipated need for any HCV therapy during the first 48 weeks of the study-and for any HCV therapy based on interferon or drugs with potential adverse drug-drug interactions with study treatment throughout the entire study period-were excluded.
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- Untreated syphilis infection (positive rapid plasma reagin [RPR] at Screening without clear documentation of treatment) resulted in exclusion. Participants who were at least 24 hours post-completed treatment were eligible.
- Participants with a history of sensitivity to any study medication or its components, or to drugs of the same class, or a history of drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicated participation, were excluded.
- Participants with ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, resected non-invasive cutaneous squamous cell carcinoma, or cervical, anal, or penile intraepithelial neoplasia were excluded. Other localized malignancies required agreement between the investigator and Study Medical Monitor for inclusion.
- Participants who, in the investigator's judgment, posed a significant suicide risk were excluded. A recent history of suicidal behavior and/or suicidal ideation could have been considered evidence of serious suicide risk.
- Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening resulted in exclusion.
- Treatment with radiation therapy, cytotoxic chemotherapeutic agents, or any systemic immune suppressant within 28 days of Screening resulted in exclusion.
- Treatment with any agent with documented activity against HIV-1 in vitro within 28 days of the first study dose resulted in exclusion.
- Receipt of any prohibited medication, and inability or unwillingness to switch to an alternative medication, resulted in exclusion.
- Exposure to an experimental drug or vaccine within 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent (whichever was longer) prior to the first study dose resulted in exclusion.
- Any evidence of pre-existing viral resistance based on any major resistance-associated mutation in Screening or historical results led to exclusion.
- Any verified Grade 4 laboratory abnormality led to exclusion. A single repeat test during Screening was allowed to verify results.
- Any acute laboratory abnormality at Screening that, in the Investigator's opinion, would have precluded participation in the study of an investigational compound resulted in exclusion.
- ALT >5× the upper limit of normal (ULN), or ALT >5× ULN with bilirubin >1.5× ULN (with >35 percent direct bilirubin), resulted in exclusion.
- Creatinine clearance <50 mL/min/1.73 m² using the Schwartz equation resulted in exclusion.
- Children who were wards of the state or government were excluded.
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
South Africa3 sites
GSK Investigational Site
Cape Town, 7500
GSK Investigational Site
Durban, 4001
GSK Investigational Site
Johannesburg, 1862
Thailand3 sites
GSK Investigational Site
Bangkok, 10330
GSK Investigational Site
Bangkok, 10700
GSK Investigational Site
Chiang Mai, 50200
Kenya2 sites
GSK Investigational Site
Kericho, 20200
GSK Investigational Site
Kisumu, 40100
About this study
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
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. This study was designed to evaluate the efficacy and safety of DTG/3TC as an FDC in ART-naive HIV-1-infected adolescents who weighed at least 25 kilograms (kg).
The study consisted of a Screening Phase (up to 28 days prior to the first dose of drug), followed by a Treatment Phase (up to 48 weeks). Participants who successfully completed 48 weeks of therapy and continued to receive benefit from DTG/3TC FDC were eligible to enter a 96-week Extension Phase. Study participants who successfully completed both the Treatment Phase through 48 weeks and the Extension Phase through 144 weeks and continued to receive benefit from this two-drug regimen were to continue receiving DTG/3TC FDC in a Continuation Phase (after Week 144) until DTG and 3TC were both locally approved for use as part of a dual regimen and the single entities of DTG and 3TC were available to participants (e.g., through public health services), or the DTG/3TC FDC tablet, if required by local regulations, was locally approved and available (e.g., commercially or through public health services), or the participant no longer derived clinical benefit, or the participant met a protocol-defined reason for discontinuation.
All participants received the FDC of DTG/3TC (50/300 milligrams) once daily.
- Conditions
- HIV Infections
- Being tested
- DTG + 3TC FDC
- Keywords
- Viral load, Dolutegravir, Lamivudine, HIV-1, Fixed dose combination, DOVATO
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DTG + 3TC FDCDrug
DTG + 3TC FDC was available as a 50/300 mg tablet to be given orally once daily.
| Study group | Role | What they receive |
|---|---|---|
| DTG/3TC FDC | Experimental | Participants received dolutegravir/lamivudine (DTG/3TC) (50/300 mg) Fixed Dose Combination (FDC) tablets orally once daily. Receives: Drug: DTG + 3TC FDC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 48
Secondary outcomes (41)
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.
Measured: 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 was assessed at Week 96 according to the FDA snapshot algorithm.
Measured: 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 was assessed at Week 144 according to the FDA snapshot algorithm.
Measured: 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.
Measured: 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 was assessed at Week 96 according to the FDA snapshot algorithm.
Measured: 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 was assessed at Week 144 according to the FDA Snapshot algorithm.
Measured: 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.
Measured: Week 48
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) 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.
Measured: Up to 144 weeks
Number of Participants With AEs Through 144 Weeks by Severity
The Division of Acquired Immunodeficiency Syndrome (DAIDS) criteria for grading the severity of adult and pediatric adverse events was used to assess severity. Grades were defined based on numeric criteria as follows: Grade 1 - mild; Grade 2 - moderate; Grade 3 - severe or medically significant; Grade 4 - life-threatening consequences; Grade 5 - death. A higher grade indicates a greater severity.
Measured: Up to 144 weeks
Number of Participants With Abnormal Findings for Hematology Parameters Through 144 Weeks
Blood samples were collected from participants for analysis of hematology parameters including hemoglobin, leukocytes and neutrophils. The DAIDS criteria for grading the severity of adult and pediatric adverse events was used to assess severity. Grades were defined based on numeric criteria as follows: Grade 0 - no abnormality; Grade 1 - mild; Grade 2 - moderate; Grade 3 - severe or medically significant; Grade 4 - life-threatening consequences.
Measured: Up to 144 weeks
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
Blood samples were collected from participants for analysis of clinical chemistry parameters including potassium, aspartate aminotransferase, creatinine, alanine aminotransferase (ALT), carbon dioxide, alkaline phosphatase, bilirubin, direct bilirubin, sodium, GFR from creatinine adjusted for BSA, calcium, and creatine kinase. Grades were defined based on numeric criteria as follows: Grade 0 - no abnormality; Grade 1 - mild; Grade 2 - moderate; Grade 3 - severe or medically significant; Grade 4 - life-threatening consequences.
Measured: Up to 144 weeks
Number of Participants With Abnormal Findings for Fasting Lipids Through 144 Weeks
Lipid assessments including cholesterol, low density lipoprotein (LDL) cholesterol, LDL Cholesterol Calculation, LDL Cholesterol Direct, and triglycerides were performed. Grades were defined based on numeric criteria as follows: Grade 0 - no abnormality; Grade 1 - mild; Grade 2 - moderate; Grade 3 - severe or medically significant; Grade 4 - life-threatening consequences.
Measured: Up to 144 weeks
Number of Participants With Abnormal Findings for Urinalysis Parameters Through 144 Weeks
Urine samples were collected from participants for the analysis of urinalysis parameters including urinary glucose, urinary protein, and urine erythrocytes. Grades were defined based on numeric criteria as follows: Grade 0 - no abnormality; Grade 1 - mild; Grade 2 - moderate; Grade 3 - severe or medically significant; Grade 4 - life-threatening consequences.
Measured: Up to 144 weeks
Number of Participants Who Discontinue Treatment Due to Adverse Events Through 144 Weeks
Measured: Up to 144 weeks
Number of Participants With Adverse Events and Serious Adverse Events Through 96 Weeks
Measured: Up to 96 weeks
Number of Participants With Severity of Adverse Events Through 96 Weeks
AEs were evaluated by the investigator and graded according to the DAIDS toxicity scales as follows: Grade 1 - mild; Grade 2 - moderate; Grade 3 - severe or medically significant; Grade 4 - life-threatening consequences; Grade 5 - death. The higher the grade, the more severe the symptoms.
Measured: Up to 96 weeks
Number of Participants With Abnormal Findings for Hematology Parameters Through 96 Weeks
Blood samples were collected from participants for analysis of hematology parameters including hemoglobin, leukocytes and neutrophils. Grades were defined based on numeric criteria as follows: Grade 0 - no abnormality; Grade 1 - mild; Grade 2 - moderate; Grade 3 - severe or medically significant; Grade 4 - life-threatening consequences.
Measured: Up to 96 weeks
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks
Blood samples were collected from participants for analysis of clinical chemistry parameters including potassium, aspartate aminotransferase, creatinine, alanine aminotransferase, carbon dioxide, alkaline phosphatase, bilirubin, sodium, GFR from creatinine adjusted for BSA, calcium, and creatine kinase. Grades were defined based on numeric criteria as follows: Grade 0 - no abnormality; Grade 1 - mild; Grade 2 - moderate; Grade 3 - severe or medically significant; Grade 4 - life-threatening consequences.
Measured: Up to 96 weeks
Number of Participants With Abnormal Findings for Fasting Lipids Through 96 Weeks
Lipid assessments including cholesterol, LDL cholesterol, LDL cholesterol calculation, LDL cholesterol direct, and triglycerides were performed. Grades were defined based on numeric criteria as follows: Grade 0 - no abnormality; Grade 1 - mild; Grade 2 - moderate; Grade 3 - severe or medically significant; Grade 4 - life-threatening consequences.
Measured: 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 urinary glucose, urinary protein, and urine erythrocytes. Grades were defined based on numeric criteria as follows: Grade 0 - no abnormality; Grade 1 - mild; Grade 2 - moderate; Grade 3 - severe or medically significant; Grade 4 - life-threatening consequences.
Measured: Up to 96 weeks
Number of Participants Undergoing Viral Load Monitoring From Week 48 Through 144 Weeks
Viral load was defined as plasma HIV-RNA <50 copies per mL. Viral load monitoring of participants was performed from Week 48 through 144 weeks.
Measured: Weeks 48, 60, 72, 84, 96, 108, 120, 132, and 144
Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Count at Weeks 24 and 48
Baseline value was defined as the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value.
Measured: Baseline (Day 1) and Weeks 24 and 48
Change From Baseline in CD8+ Cell Count at Weeks 24 and 48
Baseline value was defined as the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value.
Measured: Baseline (Day 1) and Weeks 24 and 48
Change From Baseline in Ratio of CD4+ and CD8+ at Weeks 24 and 48
Baseline value was defined as the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value.
Measured: Baseline (Day 1) and Weeks 24 and 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.
Measured: Week 24 and up to Week 48
Number of Participants With Any Adverse Events and Serious Adverse Events From Week 24 Through Week 48
Measured: Week 24 and up to Week 48
Number of Participants With Severity of Adverse Events From Week 24 Through Week 48
AEs were evaluated by the investigator and graded according to the DAIDS toxicity scales as follows: Grade 1 - mild; Grade 2 - moderate; Grade 3 - severe or medically significant; Grade 4 - life-threatening consequences; Grade 5 - death. The higher the grade, the more severe the symptoms.
Measured: 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, leukocytes and neutrophils. Grades were defined based on numeric criteria as follows: Grade 1 - mild; Grade 2 - moderate; Grade 3 - severe or medically significant; Grade 4 - life-threatening consequences.
Measured: 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 potassium, aspartate aminotransferase, creatinine, alanine aminotransferase, carbon dioxide, alkaline phosphatase, bilirubin, sodium, GFR from creatinine adjusted for BSA, calcium, and creatine kinase. Grades were defined based on numeric criteria as follows: Grade 1 - mild; Grade 2 - moderate; Grade 3 - severe or medically significant; Grade 4 - life-threatening consequences.
Measured: 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 cholesterol, LDL cholesterol, LDL cholesterol calculation, LDL cholesterol direct, and triglycerides were performed. Grades were defined based on numeric criteria as follows: Grade 1 - mild; Grade 2 - moderate; Grade 3 - severe or medically significant; Grade 4 - life-threatening consequences.
Measured: Week 24 and up to Week 48
Number of Participants With Abnormal Findings for Urinalysis Parameters From Week 24 Through Week 48
Urine samples will be collected from participants for the analysis of urinalysis parameters including urinary glucose, urinary protein, and urine erythrocytes. Grades were defined based on numeric criteria as follows: Grade 1 - mild; Grade 2 - moderate; Grade 3 - severe or medically significant; Grade 4 - life-threatening consequences.
Measured: Week 24 and up to Week 48
Number of Participants Who Discontinued Treatment Due to Adverse Events From Week 24 Through Week 48
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre-dose, 0.5, 1.0, 1.5, 2, 3, 4, 6, 10, and 24 hours post-dose at Week 1
Observed Pre-dose Plasma Concentration Following Dosing With DTG and 3TC
Blood samples were collected on a subset of participants for intensive pharmacokinetic analysis.
Measured: 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.
Measured: 24 hours post-dose at Week 1
Number of Participants With Observed Genotypic Resistance to DTG and 3TC
Protocol-defined confirmed virologic withdrawal (CVW) through Week 144 was low with 1 participant meeting CVW criteria. Resistance testing failed, and therefore no genotypic data were available for this participant at the time of virologic failure.
Measured: Up to 144 weeks
Number of Participants With Observed Phenotypic Resistance to DTG and 3TC
Protocol-defined CVW through Week 144 was low with 1 participant meeting CVW criteria. Resistance testing failed, and therefore no phenotypic data were available for this participant at the time of virologic failure.
Measured: Up to 144 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start6 May 2019
- Primary completion1 Dec 2021
- Study completion22 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by ViiV HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants received FDC of DTG/3TC (50/300 mg) once daily.
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, ViiV Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03682848
- Sponsor's protocol ID
- 205861
- Status last verified
- Nov 2025
- First submitted
- 21 Sep 2018
- Last updated
- 9 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.viiv-studyregister.com/documents/About\_ViiV\_Patient\_Level\_Data\_Sharing\_Final\_25Sep2023.pdf.
Publications
Puthanakit T, Aurpibul L, Lopez M, Wang M, Ciuffa M, Bontempo G, Cheung SYA, Deprez I, Buchanan AM, Vavro C, McKenna M, Min S, Tan LK. Efficacy and Safety of the Two-Drug Regimen Dolutegravir-Lamivudine in Adolescents Living With HIV-1 Naive to Antiretroviral Therapy at 48 Weeks (DANCE): A Single-Arm, Open-Label, Phase 3b Trial. J Acquir Immune Defic Syndr. 2025 Jun 1;99(2):202-210. doi: 10.1097/QAI.0000000000003655.
PubMed 39988749
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03682848
- Acronym / sponsor ID
- 205861
- Conditions
- HIV Infections
- Keywords
- Viral load, Dolutegravir, Lamivudine, HIV-1, Fixed dose combination, DOVATO
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Study start
- 6 May 2019 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 22 May 2025 (actual)
- First posted
- 25 Sep 2018 (actual)
- Results
- Posted 8 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. This study was designed to evaluate the efficacy and safety of DTG/3TC as an FDC in ART-naive HIV-1-infected adolescents who weighed at least 25 kilograms (kg).
The study consisted of a Screening Phase (up to 28 days prior to the first dose of drug), followed by a Treatment Phase (up to 48 weeks). Participants who successfully completed 48 weeks of therapy and continued to receive benefit from DTG/3TC FDC were eligible to enter a 96-week Extension Phase. Study participants who successfully completed both the Treatment Phase through 48 weeks and the Extension Phase through 144 weeks and continued to receive benefit from this two-drug regimen were to continue receiving DTG/3TC FDC in a Continuation Phase (after Week 144) until DTG and 3TC were both locally approved for use as part of a dual regimen and the single entities of DTG and 3TC were available to participants (e.g., through public health services), or the DTG/3TC FDC tablet, if required by local regulations, was locally approved and available (e.g., commercially or through public health services), or the participant no longer derived clinical benefit, or the participant met a protocol-defined reason for discontinuation.
All participants received the FDC of DTG/3TC (50/300 milligrams) once daily.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants received FDC of DTG/3TC (50/300 mg) once daily.
| Arm | Type | Receives |
|---|---|---|
| DTG/3TC FDC | Experimental | Drug: DTG + 3TC FDCParticipants received dolutegravir/lamivudine (DTG/3TC) (50/300 mg) Fixed Dose Combination (FDC) tablets orally once daily. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- HIV-1-infected adolescents were 12 to <18 years of age at the time of signing the informed consent form.
- Weight was >25 kg at the time of signing the informed consent form.
- Screening plasma HIV-1 RNA was between 1,000 and =500,000 c/mL.
- Participants were antiretroviral-naive (defined as having had no prior therapy with any antiretroviral agent for the treatment of HIV following a diagnosis of HIV-1 infection). Participants who had received ART for prevention of mother-to-child transmission of HIV in the first 3 months of life were allowed. Participants who had received HIV post-exposure prophylaxis (PEP) or pre-exposure prophylaxis (PrEP) in the past were allowed as long as the last PEP/PrEP dose was = 6 months before HIV diagnosis or there was documented HIV seronegativity at least 2 months after the last prophylactic dose and prior to the date of HIV diagnosis.
- Male and female participants were included. A female participant was eligible to participate if she was not pregnant (as confirmed by a negative serum human chorionic gonadotropin [hCG] test at Screening and a negative urine hCG test before Enrollment) and not lactating. Female participants of child-bearing potential who were engaging in sexual activity that could have led to pregnancy had to agree to use one birth-control method from 28 days prior to the first dose of study medication until 4 weeks after the last dose of study medication (and completion of the follow-up visit). Condoms were additionally recommended, as appropriate use was the only contraceptive method effective in preventing HIV-1 transmission. The investigator was responsible for ensuring that participants understood how to properly use these contraceptive methods. All participants in the study were also counseled on safer sexual practices, including the use and benefit/risk of effective barrier methods (e.g., male condoms), as well as on the risk of HIV transmission to an uninfected partner.
Key exclusion criteria (21 listed)
- Females who were breastfeeding or who planned to become pregnant or breastfeed during the study were excluded.
- Any evidence of 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 <200 cells/mm³ or CD4 percent <15 percent resulted in exclusion.
- Participants with severe hepatic impairment (Class C) as determined by the Child-Pugh classification were excluded.
- Participants with unstable liver disease (defined by ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, or known biliary abnormalities (except Gilbert's syndrome or asymptomatic gallstones) were excluded.
- Evidence of hepatitis B virus (HBV) infection at Screening led to exclusion as follows: participants positive for HBsAg were excluded; participants negative for anti-HBs but positive for anti-HBc (negative HBsAg) and positive for HBV DNA were excluded. Participants positive for anti-HBc (negative HBsAg) and anti-HBs (past and/or current evidence) were immune to HBV and were not excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DTG + 3TC FDCDTG + 3TC FDC was available as a 50/300 mg tablet to be given orally once daily. | Drug | DTG/3TC FDC |
Primary outcome
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
Time frame: 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.
41 secondary outcomes
Percentage of Participants With Plasma HIV-1 RNA <200 c/mL at Week 24
Time frame: Week 24
Percentage of Participants With Plasma HIV-1 RNA <200 c/mL at Week 96
Time frame: Week 96
Percentage of Participants With Plasma HIV-1 RNA <200 c/mL at Week 144
Time frame: Week 144
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 24
Time frame: Week 24
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 96
Time frame: Week 96
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 144
Time frame: Week 144
Percentage of Participants With Plasma HIV-1 RNA <200 c/mL at Week 48
Time frame: Week 48
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Through 144 Weeks
Time frame: Up to 144 weeks
Number of Participants With AEs Through 144 Weeks by Severity
Time frame: Up to 144 weeks
Number of Participants With Abnormal Findings for Hematology Parameters Through 144 Weeks
Time frame: Up to 144 weeks
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
Time frame: Up to 144 weeks
Number of Participants With Abnormal Findings for Fasting Lipids Through 144 Weeks
Time frame: Up to 144 weeks
Number of Participants With Abnormal Findings for Urinalysis Parameters Through 144 Weeks
Time frame: Up to 144 weeks
Number of Participants Who Discontinue Treatment Due to Adverse Events Through 144 Weeks
Time frame: Up to 144 weeks
Number of Participants With Adverse Events and Serious Adverse Events Through 96 Weeks
Time frame: Up to 96 weeks
Number of Participants With Severity of Adverse Events Through 96 Weeks
Time frame: Up to 96 weeks
Number of Participants With Abnormal Findings for Hematology Parameters Through 96 Weeks
Time frame: Up to 96 weeks
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks
Time frame: Up to 96 weeks
Number of Participants With Abnormal Findings for Fasting Lipids Through 96 Weeks
Time frame: Up to 96 weeks
Number of Participants With Abnormal Findings for Urinalysis Parameters Through 96 Weeks
Time frame: Up to 96 weeks
Number of Participants Undergoing Viral Load Monitoring From Week 48 Through 144 Weeks
Time frame: Weeks 48, 60, 72, 84, 96, 108, 120, 132, and 144
Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Count at Weeks 24 and 48
Time frame: Baseline (Day 1) and Weeks 24 and 48
Change From Baseline in CD8+ Cell Count at Weeks 24 and 48
Time frame: Baseline (Day 1) and Weeks 24 and 48
Change From Baseline in Ratio of CD4+ and CD8+ at Weeks 24 and 48
Time frame: Baseline (Day 1) and Weeks 24 and 48
Number of Participants With Disease Progression From Week 24 Through Week 48
Time frame: Week 24 and up to Week 48
Number of Participants With Any Adverse Events and Serious Adverse Events From Week 24 Through Week 48
Time frame: Week 24 and up to Week 48
Number of Participants With Severity of Adverse Events From Week 24 Through Week 48
Time frame: Week 24 and up to Week 48
Number of Participants With Abnormal Findings for Hematology Parameters From Week 24 Through Week 48
Time frame: Week 24 and up to Week 48
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Time frame: Week 24 and up to Week 48
Number of Participants With Abnormal Findings for Fasting Lipids From Week 24 Through Week 48
Time frame: Week 24 and up to Week 48
Number of Participants With Abnormal Findings for Urinalysis Parameters From Week 24 Through Week 48
Time frame: Week 24 and up to Week 48
Number of Participants Who Discontinued Treatment Due to Adverse Events From Week 24 Through Week 48
Time frame: Week 24 and up to Week 48
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 at Week 1
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 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
Time frame: 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
Time frame: 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
Time frame: Pre-dose, 0.5, 1.0, 1.5, 2, 3, 4, 6, 10, and 24 hours post-dose at Week 1
Observed Pre-dose Plasma Concentration Following Dosing With DTG and 3TC
Time frame: Pre-dose at Week 1
Observed Plasma Concentration at 24 Hours Following Dosing With DTG and 3TC
Time frame: 24 hours post-dose at Week 1
Number of Participants With Observed Genotypic Resistance to DTG and 3TC
Time frame: Up to 144 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39988749Puthanakit T, Aurpibul L, Lopez M, Wang M, Ciuffa M, Bontempo G, Cheung SYA, Deprez I, Buchanan AM, Vavro C, McKenna M, Min S, Tan LK. Efficacy and Safety of the Two-Drug Regimen Dolutegravir-Lamivudine in Adolescents Living With HIV-1 Naive to Antiretroviral Therapy at 48 Weeks (DANCE): A Single-Arm, Open-Label, Phase 3b Trial. J Acquir Immune Defic Syndr. 2025 Jun 1;99(2):202-210. doi: 10.1097/QAI.0000000000003655.
- Individual participant dataSharing planned: Yes. Study sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.viiv-studyregister.com/documents/About_ViiV_Patient_Level_Data_Sharing_Final_25Sep2023.pdf.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
ViiV Healthcare
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DTG + 3TC FDC in people with HIV Infections, run by ViiV Healthcare at 8 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in South Africa, Thailand, Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03682848, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.