Strategy for Maintenance of HIV Suppression With Once Daily Integrate Inhibitor+Darunavir/Ritonavir in Children
NCT ID: NCT02383108
Last Updated: 2021-03-30
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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COMPLETED
PHASE2/PHASE3
318 participants
INTERVENTIONAL
2016-06-30
2020-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard of Care group (SOC)
triple anti-retroviral therapy including 2 NRTIs + boosted PI/NNRTI
SOC
Standard of care (continuing triple anti-retroviral therapy including 2 NRTIs + boosted PI/NNRTI)
DTG+DRV/r
NRTI-sparing regimen: Once daily integrase inhibitor (INSTI) + darunavir/ritonavir (DRV/r)
DTG +DRV/r
NRTI-sparing regimen: Once daily integrase inhibitor (INSTI) + darunavir/ritonavir (DRV/r)
Interventions
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DTG +DRV/r
NRTI-sparing regimen: Once daily integrase inhibitor (INSTI) + darunavir/ritonavir (DRV/r)
SOC
Standard of care (continuing triple anti-retroviral therapy including 2 NRTIs + boosted PI/NNRTI)
Eligibility Criteria
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Inclusion Criteria
2. Aged 12 to \< 18 years old\*\*
3. Parents or guardians, and children where appropriate, willing and able to give informed consent and to adhere to the protocol
4. Children must have all HIV-1 RNA viral loads \<50c/mL for at least 12 months with a minimum of two separate results before screening.
5. Children on a 3-drug PI/r or NNRTI containing regimen for at least 24 weeks
6. Children/parents/guardians prepared to switch if randomised to once daily integrase inhibitor + DRV/RTV arm
7. Children and parents prepared to restart the current ART regimen after simplification if viral load restart criteria are met (see Section 5.5)
8. Be affiliated or beneficiary to Health Social security scheme (in countries where this is mandatory)
* Initially enrolment will be of participants ≥ 12 years old and ≥40kg only. DTG 50 mg will be supplied by ViiV Healthcare.
* As more data become available on younger children, a protocol amendment is planned to include younger children and/or lower weight bands.
Exclusion Criteria
2. Evidence of resistance to DRV or integrase inhibitors (for participants in clinical sites where resistance testing is standard of care)
3. Previous exposure to integrase inhibitors for more than 2 weeks
4. Intercurrent illness (randomisation can take place after the illness resolves)
5. Creatinine ≥ 1.8ULN or ALT ≥ 5ULN or ALT ≥ 3ULN and bilirubin ≥2ULN at screening.
6. 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), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
7. Diagnosis of tuberculosis and on anti-tuberculosis treatment (children can be enrolled after successful tuberculosis treatment)
8. Hepatitis B or Hepatitis C co-infection
9. Pregnancy or risk of pregnancy in girls of child-bearing potential unless committed to taking effective contraception
10. History or presence of known allergy or some other contraindication to the study drugs or their components as described in the SmPC
12 Years
17 Years
ALL
No
Sponsors
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Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
MRC CTU at UCL
UNKNOWN
PHPT
UNKNOWN
PENTA Foundation
NETWORK
Responsible Party
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Locations
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Hospital Garrahan
Buenos Aires, , Argentina
Centre Hospitalier Andrée Rosemon
Cannes, , France
CHU Hôtel Dieu - Nantes
Nantes, , France
Hospital General Mexico
Mexico City, , Mexico
Hospital de Dona Estefânia - CHLC
Lisbon, , Portugal
Centro Materno-Infantil de Norte
Porto, , Portugal
FAM-CRU
Cape Town, , South Africa
PHRU
Soweto, , South Africa
Hospital San Joan de Deu
Barcelona, , Spain
Hospital Clínico San Carlos
Madrid, , Spain
Hospital General Gregorio Marañón
Madrid, , Spain
Hospital La Paz
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario de Getafe
Madrid, , Spain
Inselpital Bern
Bern, , Switzerland
Kantonsspital St Gallen
Sankt Gallen, , Switzerland
Kinderspital Zurich
Zurich, , Switzerland
Prapokklao Hospital
Chanthaburi, , Thailand
Nakornping Hospital
Chiang Mai, , Thailand
Chiangrai Prachanukroh Hospital
Chiang Rai, , Thailand
Kalasin hospital
Kalasin, , Thailand
Khonkaen hospital
Khon Kaen, , Thailand
Phayao hospital
Phayao, , Thailand
Baylor
Kampala, , Uganda
JCRC
Mbarara, , Uganda
Kiev
Kiev, , Ukraine
Kryvyi Rih
Kryvyi Rih, , Ukraine
Birmingham Heartlands Hospital
Birmingham, , United Kingdom
Bristol Hospital
Bristol, , United Kingdom
Evelina Children Hospital, St Thomas's Hospital
London, , United Kingdom
King's College Hospital
London, , United Kingdom
Countries
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References
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Compagnucci A, Chan MK, Saidi Y, Cressey TR, Bamford A, Riault Y, Coelho A, Nolan A, Chalermpantmetagul S, Morkunaite G, Amuge P, Musiime V, Violari A, Cotton M, Kekitiinwa AR, Kaudha E, Groenewald M, Liberty AA, Kanjanavanit S, Volokha A, Bologna R, Pavia Ruz N, Prieto Tato L, Paioni P, Marques L, Reliquet V, Niehues T, Welch SB, Ford D, Giaquinto C, Gibb DM, Babiker A, Ramos Amador JT; SMILE-PENTA17-ANRS 152 Trial Group. Nucleoside/nucleotide reverse transcriptase inhibitor sparing regimen with once daily integrase inhibitor plus boosted darunavir is non-inferior to standard of care in virologically-suppressed children and adolescents living with HIV - Week 48 results of the randomised SMILE Penta-17-ANRS 152 clinical trial. EClinicalMedicine. 2023 Jun 2;60:102025. doi: 10.1016/j.eclinm.2023.102025. eCollection 2023 Jun.
Other Identifiers
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ANRS1 52
Identifier Type: OTHER
Identifier Source: secondary_id
SMILE (PENTA 17)
Identifier Type: -
Identifier Source: org_study_id
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