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.
A two arm parallel group, non-inferiority, open-label, multi-centre, randomised controlled trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
318
NRTI-sparing regimen: Once daily integrase inhibitor (INSTI) + darunavir/ritonavir (DRV/r)
Standard of care (continuing triple anti-retroviral therapy including 2 NRTIs + boosted PI/NNRTI)
Hospital Garrahan
Buenos Aires, Argentina
Percentage of patients with HIV-1 RNA ever ≥ 50 c/mL (confirmed within 4 weeks)
Time frame: at any time up to week 48
Percentage of patients with HIV-1 RNA < 50 c/mL
Time frame: at week 48
Percentage of patients with HIV-1 RNA ≥ 50 c/mL
Time frame: at week 24
Percentage of patients withHIV-1 RNA ≥ 400c/mL
Time frame: at week 24 and week 48
Percentage of patients with any grade 3 or 4 clinical adverse events (particularly lipodystrophy); any grade 3 or 4 laboratory adverse events
Time frame: over 48 weeks
All grade 3 or 4 laboratory adverse events
Time frame: over 48 weeks
Any adverse event at least possibly related to study drugs or leading to treatment modifications
Time frame: over 48 weeks
Occurrence of new resistance mutations
Time frame: over 48 weeks
Changes in CD4 (absolute and percentage)
Time frame: from baseline to weeks 24 and 48
Change in ART (defined as any change from the ART regimen at randomisation)
Time frame: at week 0
New or recurrent CDC/WHO stage C or severe stage B event or death
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Centre Hospitalier Andrée Rosemon
Cannes, France
CHU Hôtel Dieu - Nantes
Nantes, France
Hospital General Mexico
Mexico City, Mexico
Hospital de Dona Estefânia - CHLC
Lisbon, Portugal
Centro Materno-Infantil de Norte
Porto, Portugal
FAM-CRU
Cape Town, South Africa
PHRU
Soweto, South Africa
Hospital San Joan de Deu
Barcelona, Spain
Hospital Clínico San Carlos
Madrid, Spain
...and 21 more locations
Time frame: over 48 weeks
Blood lipids
Time frame: over 48 weeks
Adherence as measured by questionnaire and visual analogue scale
Time frame: over 48 weeks
Acceptability and quality of life over 48 weeks as assessed by patient completed questionnaires
Time frame: over 48 weeks
Tanner scales (in participants aged over 8 years)
Time frame: over 48 weeks
Date of first menses
Time frame: over 48 weeks
Height
Time frame: Over 48 weeks
Weight
Time frame: over 48 weeks