A Two-arm, Phase 2/3 Multicentre, Open-label, Randomised Study Evaluating Safety and Antiviral Effect of Current Standard Antiretroviral Therapy Compared to Once Daily Integrase Inhibitor Administered With Darunavir/Ritonavir (DRV/r) in HIV-1 Infected, Virologically Suppressed Paediatric Participants.

CompletadoFase 3ClinicalTrials.gov

ID: NCT02383108Tipo: INTERVENTIONALInicio: 1 de jun de 2016Fin estimado: 1 de oct de 2020

Traducción no disponible, mostrando original

Resumen

A two-arm, Phase 2/3 multicentre, open-label, randomised study evaluating safety and antiviral effect of current standard antiretroviral therapy compared to once daily integrase inhibitor administered with darunavir/ritonavir (DRV/r) in HIV-1 infected, virologically suppressed paediatric participants.

Descripción detallada

A two arm parallel group, non-inferiority, open-label, multi-centre, randomised controlled trial.

Elegibilidad

Edad mínima: 12 YearsEdad máxima: 17 YearsSexo: ALL

Criterios de inclusión

HIV-1 infected children aged ≥ 12 years old and weighing ≥40kg\* at the screening visit
Aged 12 to \< 18 years old\*\*
Parents or guardians, and children where appropriate, willing and able to give informed consent and to adhere to the protocol
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.
Children on a 3-drug PI/r or NNRTI containing regimen for at least 24 weeks
Children/parents/guardians prepared to switch if randomised to once daily integrase inhibitor + DRV/RTV arm
Children and parents prepared to restart the current ART regimen after simplification if viral load restart criteria are met (see Section 5.5)
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.

Criterios de exclusión

Receiving or requiring agents with interactions with DRV, RTV, or any once daily integrase inhibitor (Appendix 14)
Evidence of resistance to DRV or integrase inhibitors (for participants in clinical sites where resistance testing is standard of care)
Previous exposure to integrase inhibitors for more than 2 weeks
Intercurrent illness (randomisation can take place after the illness resolves)
Creatinine ≥ 1.8ULN or ALT ≥ 5ULN or ALT ≥ 3ULN and bilirubin ≥2ULN at screening.
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)
Diagnosis of tuberculosis and on anti-tuberculosis treatment (children can be enrolled after successful tuberculosis treatment)
Hepatitis B or Hepatitis C co-infection
Pregnancy or risk of pregnancy in girls of child-bearing potential unless committed to taking effective contraception
History or presence of known allergy or some other contraindication to the study drugs or their components as described in the SmPC

Intervenciones

drug

DTG +DRV/r

NRTI-sparing regimen: Once daily integrase inhibitor (INSTI) + darunavir/ritonavir (DRV/r)

drug

SOC

Standard of care (continuing triple anti-retroviral therapy including 2 NRTIs + boosted PI/NNRTI)

Ubicaciones

Hospital Garrahan

Buenos Aires, Argentina

Patrocinadores

PrincipalPENTA Foundation

ColaboradorInstitut National de la Santé Et de la Recherche Médicale, France

ColaboradorMRC CTU at UCL

ColaboradorPHPT

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