PENTA 17 - SMILE

Phase 1

• Conditions: HIV-1 Infection; MedDRA version: 20.0Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 100000020174; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2013-001476-37-GB
• Lead Sponsor: PENTA Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-17
• Last Update Posted: 9 October 2017

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1.HIV-1 infected children aged = 12 years old and weighing =40kg* 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 once daily integrase inhibitor + darunavir/ritonavir arm
7.Children and parents prepared to restart the current ART regimen after simplification if viral load restart criteria are met

* 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.

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 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1.Receiving or requiring agents with interactions with darunavir, RTV, or once daily intergrase inhibitors
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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate whether treatment with a once daily integrase inhibitor + DRV/r based combination works as well as the standard HIV treatment in children in terms of suppressing the HIV virus.;Secondary Objective: To evaluate if treatment with integrase inhibitor + DRV/r is better in terms of safety than standard HIV treatment in children. We will also be comparing the differences between the two arms (standard of care vs integrase inhibitor + DRV/r) with respect to immune system, drug resistance, blood lipids, adherence to and acceptability of HIV treatment and the onset of puberty. ;Primary end point(s): Percentage of patients with HIV-1 RNA = 50 c/mL (confirmed within 4 weeks) at any time up to week 48.;Timepoint(s) of evaluation of this end point: At any time up to week 48.