SMILE: Strategy for Maintenance of HIV suppression with elvitegravir+darunavir/ritonavir in children (PENTA 17)

Phase 1

• Conditions: Paediatric HIV-1 Infection; MedDRA version: 18.0Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2013-001476-37-ES
• Lead Sponsor: Fondazione PENTA ONLUS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-05
• Study Completion: 2021-11-17
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 318

Inclusion Criteria

1.HIV-1 infected children weighting > 17 kg at the screening visit
2.Aged 6 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 6 months.
6.Children/parents/guardians prepared to switch if randomised to elvitegravir + darunavir/ritonavir arm
7.Children and parents prepared to restart the current ART regimen after simplification if viral load restart criteria are met
8.For children aged 6-12 either:
-children and caregivers are willing to participate in the lead-in PK study if the child is aged 6-12 and the PK study (for children randomised to Arm 1) is still enrolling children in their weight band OR
- Data from the lead-in PK study have been analysed and children aged 6-12 can be enrolled directly into the main study
Are the trial subjects under 18? yes
Number of subjects for this age range: 300
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Receiving or requiring agents with interactions with darunavir, RTV, or EVG
2.Evidence of resistance to DRV or integrase inhibitors
3.Previous exposure to integrase inhibitors for more than 2 weeks
4.History of previous encephalopathy
5.Intercurrent illness
6.Creatinine, AST or ALT of grade 3 or above at screening.
7.Diagnosis of tuberculosis and on anti-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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate wether children with chronic HIV infection on ART with suppressed viral load will maintain similar levels of suppression with elvitegravir+ darunavir/r (EVG+DRV/r) compared to current standard of care triple ART.;Secondary Objective: - To evaluate the PK of EVG+DRV/r<br>- To evaluate the impact on clinical progression, inmmunovirological parameters, mitochondrial toxicity, lipid profile, bone mineral density, adherence, acceptability and quality of life of the Dual combination of EVG+DRV/r compared to current standard of care triple ART.;Primary end point(s): Percentage of patients with HIV-1 RNA =50 c/mL (confirmed within 4 weeks);Timepoint(s) of evaluation of this end point: Any time up to week 48