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. 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 Overview

• Status: Completed
• 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
  • Cape Town, South Africa, 7500
    • GSK Investigational Site
  • Durban, South Africa, 4001
    • GSK Investigational Site
  • Johannesburg, South Africa, 1862
    • GSK Investigational Site
• Thailand
  • Bangkok, Thailand, 10330
    • GSK Investigational Site
  • Bangkok, Thailand, 10700
    • GSK Investigational Site
  • Chiang Mai, Thailand, 50200
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 13 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• 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.

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: DTG/3TC FDC; Participants received dolutegravir/lamivudine (DTG/3TC) (50/300 mg) Fixed Dose Combination (FDC) tablets orally once daily.	Drug: DTG + 3TC FDC; DTG + 3TC FDC was available as a 50/300 mg 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 <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 <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 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
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 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
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.	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.	Week 144
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.	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.	Week 144
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.	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.	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.	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.	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.	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.	Up to 144 weeks
Number of Participants Who Discontinue Treatment Due to Adverse Events Through 144 Weeks		Up to 144 weeks
Number of Participants With Adverse Events and Serious Adverse Events Through 96 Weeks		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.	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.	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.	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.	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.	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.	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.	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.	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.	Baseline (Day 1) and Weeks 24 and 48
Number of Participants With Any Adverse Events and Serious Adverse Events From Week 24 Through Week 48		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.	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.	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.	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.	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.	Week 24 and up to Week 48
Number of Participants Who Discontinued Treatment Due to Adverse Events From Week 24 Through Week 48		Week 24 and up to Week 48
Observed Pre-dose Plasma 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
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.	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.	Up to 144 weeks

Collaborators and Investigators

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

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2019
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): May 22, 2025

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): December 9, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

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

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• 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