NCT02383108

Strategy for Maintenance of HIV Suppression With Once Daily Integrate Inhibitor+Darunavir/Ritonavir in Children

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.

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 318 (actual)
• Sponsor: PENTA Foundation · Network
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• HIV Infection

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2016-06-01
• Primary completion: 2020-08-01
• Completion: 2020-10-01
• First posted: 2015-03-09
• Last updated: 2021-03-30

Locations

31 sites across 11 countries: Argentina, France, Mexico, Portugal, South Africa, Spain, Switzerland, Thailand, Uganda, Ukraine, United Kingdom