DTG/3TC Fixed Dose Formulations for the Maintenance of Virological Suppression in Children With HIV Infection Aged 2 to <15 Years Old
NCT ID: NCT04337450
Last Updated: 2025-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2/PHASE3
386 participants
INTERVENTIONAL
2022-04-22
2025-09-30
Brief Summary
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Detailed Description
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After 96 weeks, children who were randomised to the DTG/3TC arm will enter the extended follow-up continuing to receive DTG/3TC.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SOC
Standard-of-care (SOC)
SOC
2 nucleos(t)ide reverse transcriptase inhibitor (NRTI) and a third (anchor) drug (either an integrase strand transfer inhibitor (INSTI), a protease inhibitor (PI) or a non- nucleoside reverse transcriptase inhibitor (NNRTI)
DTG/3TC
Dolutegravir (DTG) and lamivudine (3TC) (known as DTG/3TC)
Dolutegravir (DTG) and lamivudine (3TC)
Children randomised to the DTG/3TC arm will receive once daily DTG/3TC fixed dose combination dispersible or film-coated tablets dosed using WHO weight bands criteria
Interventions
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Dolutegravir (DTG) and lamivudine (3TC)
Children randomised to the DTG/3TC arm will receive once daily DTG/3TC fixed dose combination dispersible or film-coated tablets dosed using WHO weight bands criteria
SOC
2 nucleos(t)ide reverse transcriptase inhibitor (NRTI) and a third (anchor) drug (either an integrase strand transfer inhibitor (INSTI), a protease inhibitor (PI) or a non- nucleoside reverse transcriptase inhibitor (NNRTI)
Eligibility Criteria
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Inclusion Criteria
2. Aged 2 to \<15 years old
3. Weight 6 kg or higher
4. Children on the same triple-drug PI/r, NNRTI or INSTI containing ART regimen for at least 3 months
5. Girls who have reached menarche must have a negative pregnancy test at screening and randomisation
6. Girls who are sexually active must be willing to adhere to highly effective methods of contraception
7. A parent or legal guardian is willing and able to give informed consent on behalf of the child as per national legislation and willing to adhere to the protocol
8. Participant is willing to give informed assent if the trial site clinician deems them old enough and able to understand the age-appropriate information about participation in the study
1. Participants remain on DTG/3TC at the end of the randomised phase, and in the opinion of the treating physician, derive ongoing benefit from DTG/3TC
2. Participants have no access to weight-appropriate DTG/3TC formulation via their national programme
Exclusion Criteria
2. Any changes in ART in the last 6 months for reasons other than due to child's growth, drug stock-outs, changes in country guidelines and treatment simplification
3. Evidence of previous resistance to 3TC or INSTI
4. Any prior use of regimens consisting of single or dual NRTIs with the exception of a course of zidovudine for PMTCT
5. Known allergy or contraindications to dolutegravir or lamivudine
6. Diagnosis of tuberculosis and on anti-tuberculosis treatment; children can be enrolled after successful tuberculosis treatment
7. Treatment of co-morbidities with drugs which have significant interactions with antiretroviral treatment, requiring dose adjustment of the study drugs (children can be enrolled after the illness resolves)
8. Randomisation visit more than 12 weeks after the most recent screening visit
9. Evidence of hepatitis B infection with no protective immunity against hepatitis B: participants positive for HBsAg or HBcAb and negative for HBsAb
10. Anticipated need for hepatitis C virus therapy with interferon-based regimen prior to the primary endpoint.
11. Screening ALT equal to 3 or more times the upper limit of normal AND bilirubin equal to 2 or more times the upper limit of normal (ALT ≥3xULN AND bilirubin ≥2xULN)
12. Screening ALT equal to 5 or more times the upper limit of normal ALT (≥5xULN)
13. Patients with severe hepatic impairment or unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, or persistent jaundice), or known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
14. Screening creatinine clearance \<50 mL/min/1.73m2
15. Patients aged ≥6 years at moderate or high risk of suicide as determined by Columbia-Suicide Severity Rating Scale (C-SSRS)
16. Girls who are pregnant or breastfeeding
17. Children who are in the legal custody of the State and do not have a parent or guardian able to provide informed consent on their behalf.
2 Years
15 Years
ALL
No
Sponsors
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MRC CTU at UCL
UNKNOWN
AMS-CMU/IRD (PHPT)
UNKNOWN
Chris Hani Baragwanath Academic Hospital
OTHER
Durban International Clinical Research Site
UNKNOWN
Hospital Universitario 12 de Octubre
OTHER
Prapokklao Hospital, Chantaburi
UNKNOWN
Chiangrai Prachanukroh Hospital
OTHER
Nakornping Hospital
OTHER
Khon Kaen Hospital
OTHER_GOV
Kalasin Hospital
OTHER
Joint Clinical Research Center
OTHER
MU-JHU CARE
OTHER
Baylor College of Medicine
OTHER
Great Ormond Street Hospital for Children NHS Foundation Trust
OTHER
University Hospital Birmingham NHS Foundation Trust
OTHER
Department of Clinical Pharmacy, University Medical Centre St Radboud, The Netherlands.
OTHER
Advanced Pathogens Diagnostics Unit, University College London Hospitals
UNKNOWN
Centre for Health Economics, University of York
UNKNOWN
Department of Molecular and Clinical Pharmacology, University of Liverpool
UNKNOWN
St Mary's NHS Trust
OTHER_GOV
Chang Mai Univerity
UNKNOWN
PENTA Foundation
NETWORK
Responsible Party
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Locations
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King Edward VIII Hospital
Durban, , South Africa
PHRU Klerksdorp
Klerksdorp, , South Africa
PHRU
Soweto, , South Africa
Hospital Universitario 12 de Octubre
Madrid, , Spain
Prapokklao Hospital
Chanthaburi, , Thailand
Nakornping Hospital
Chiang Mai, , Thailand
Chiangrai Prachanukroh Hospital
Chiang Rai, , Thailand
Khon Kaen Hospital
Khon Kaen, , Thailand
Baylor
Kampala, , Uganda
Joint Clinical Research Centre
Kampala, , Uganda
MUJHU
Kampala, , Uganda
Birmingham Heartlands Hospital
Birmingham, , United Kingdom
Great Ormand Street Hospital
London, , United Kingdom
St. Mary's Hospital
London, , United Kingdom
Countries
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References
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Turkova A, Chan MK, Kityo C, Kekitiinwa AR, Musoke P, Violari A, Variava E, Archary M, Cressey TR, Chalermpantmetagul S, Sawasdichai K, Ounchanum P, Kanjanavanit S, Srirojana S, Srirompotong U, Welch S, Bamford A, Epalza C, Fortuny C, Colbers A, Nastouli E, Walker S, Carr D, Conway M, Spyer MJ, Parkar N, White I, Nardone A, Thomason MJ, Ferrand RA, Giaquinto C, Ford D; D3 trial team. D3/Penta 21 clinical trial design: A randomised non-inferiority trial with nested drug licensing substudy to assess dolutegravir and lamivudine fixed dose formulations for the maintenance of virological suppression in children with HIV-1 infection, aged 2 to 15 years. Contemp Clin Trials. 2024 Jul;142:107540. doi: 10.1016/j.cct.2024.107540. Epub 2024 Apr 16.
Botha JC, Byott M, Spyer MJ, Grant PR, Gartner K, Chen WX, Burton J, Bamford A, Waters LJ, Giaquinto C, Turkova A, Vavro CL, Nastouli E. Sensitive HIV-1 DNA Pol Next-Generation Sequencing for the Characterisation of Archived Antiretroviral Drug Resistance. Viruses. 2023 Aug 25;15(9):1811. doi: 10.3390/v15091811.
Related Links
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Related Info
Related Info
Other Identifiers
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D3 (Penta21)
Identifier Type: -
Identifier Source: org_study_id
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