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

Phase 2

Completed

• Conditions: HIV infection; Infections and Infestations

• Registration Number: ISRCTN11193709
• Lead Sponsor: PENTA Foundation

Brief Summary

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37304494/ (added 12/06/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-06
• Study Completion: 2020-09-30
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 318

Inclusion Criteria

1. HIV-1 infected children weighing = 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 load <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 (see Section 5.5)
8. For children aged 6-12 either:
8.1. Children and caregivers are willing to participate in the lead-in PK study if the child is aged 6-12 and the PK study is still enrolling children in their weight band* OR
8.2. Data from the lead-in PK study have been analysed and children aged 6-12 can be enrolled directly into the main study

* only children randomised to Arm 1 will take part

Exclusion Criteria

1. Receiving or requiring agents with interactions with darunavir, RTV, or EVG
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. History of previous encephalopathy
5. Intercurrent illness (randomisation can take place after the illness resolves)
6. Creatinine, AST or ALT of grade 3 or above at screening.
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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients with HIV-1 RNA ever =50 copies/ml (confirmed within 4 weeks) at any time up to week 48