study of cobicistat-boosted atazanavir (atv/co), cobicistat-boosted darunavir (drv/co) and emtricitabine/tenofovir alafenamide (f/taf) in children with hiv

Conditions: Acquired Immune Deficiency Syndrome (AIDS); HIV Infections

Summary: the goal of this clinical study is to learn more about the safety and dosing of study drugs, cobicistat-boosted atazanavir (atv/co), cobicistat-boosted darunavir (drv/co) and emtricitabine/tenofovir alafenamide (f/taf), in children (age ≥ 4 weeks to \< 18 years) with hiv.


Eligibility criteria:
key inclusion criteria: * hiv-1 infected, virologically suppressed males and females age ≥ 4 weeks to \< 18 years (according to requirements of enrolling cohort). * body weight at screening ≥ 25 to \< 40 kg (cohort 2); ≥ 14 to \< 25 kg (cohort 3); ≥ 3 to \< 25 kg (cohort 4); ≥ 3 to \< 14 kg (cohort 5). * stable antiretroviral (arv) regimen for a minimum of 3 months prior to the screening visit. * participants enrolled prior to implementation of amendment 7: 2 nucleoside reverse transcriptase inhibitors (nrtis) and ritonavir-boosted atazanavir (atv/r) once daily or ritonavir-boosted darunavir (drv/r) once daily or twice daily. * participants enrolled after the implementation of amendment 9: * cohorts 2, 3 and 4 (group 1): 2 nrtis plus a third agent per local prescribing guidelines. participants will switch from their current third agent to atv or darunavir (drv) at day 1. participants taking drv must be on once-daily dosing or must switch to once daily at or prior to day 1. cohort 4 (group 1), participants may also switch their current third agent to lopinavir boosted with ritonavir (lpv/r) at day 1. participants will switch their nrti backbone to emtricitabine/tenofovir alafenamide (coformulated; descovy®) (f/taf). * cohort 4 (groups 2 to 4) and cohort 5 (groups 1 to 3): 2 nrtis plus a third agent per local prescribing guidelines or treatment naive. participants on treatment will switch from their current third agent to atv or lpv/r (cohort 4 (groups 2 to 4)), or to a third unboosted agent (cohort 5 (groups 1 to 3)). participants will switch their nrti backbone to f/taf. * participants undergoing dose modifications to their arv regimen for growth or switching medication formulations are considered to be on a stable arv regimen. * documented plasma human immunodeficiency virus type 1 (hiv-1) ribonucleic acid (rna) for ≥ 3 months preceding the screening visit: * participants enrolled after the implementation of amendment 9: * for cohorts 2, 3, and 4 (group 1), virologically suppressed ≥ 3 months preceding the screening visit: hiv-1 rna \< 50 copies/ml on a stable regimen (or undetectable hiv-1 rna level according to the local assay being used if the limit of detection is ≥ 50 copies/ml). * for cohorts 4 (groups 2 to 4) and cohort 5 (groups 1 to 3), on an arv regimen irrespective of plasma hiv-1 rna copies or treatment naive; a participant is considered treatment naive, if arvs were given for prevention of mother-to-child transmission but not for hiv treatment. * for virologically suppressed participants, unconfirmed virologic elevations of hiv-1 rna ≥ 50 copies/ml (transient detectable viremia, or "blip") prior to screening are acceptable. if the lower limit of detection of the local hiv-1 rna assay is \< 50 copies/ml (eg, \< 20 copies/ml), the plasma hiv-1 rna level cannot exceed 50 copies/ml on 2 consecutive hiv-1 rna tests. * adequate renal function: estimated glomerular filtration rate (egfr) ≥ 90 ml/min/1.73m2 using the schwartz formula. if ≥ 1 year old, egfr greater than or equal to the minimum normal value for age using the schwartz formula. if \< 1 year old as follows: * age minimum value for egfr (ml/min/1.73 m2) \> 28 days to ≤ 95 days is 30, ≥ 96 days to ≤ 6 months is 39, \> 6 to \< 12 months is 49. * participants must not have documented or suspected resistance to applicable study drugs including emtricitabine (emtriva®) (ftc), tfv, atv, drv, or lpv. participants \< 14 kg (cohorts 4 (groups 2 to 4) and 5 (groups 1 to 3)) with m184v/i and hiv-1 rna \< 50 copies/ml will be allowed. * positive confirmatory hiv test (confirmatory nucleic acid-based testing if \< 18 months of age). * cohort 4 (groups 2 to 4) and cohort 5 (groups 1 to 3): last dose of nevirapine or efavirenz, if applicable, ≥ 14 days prior to enrollment. note: other protocol defined inclusion/exclusion criteria do apply.

Keywords: pediatrics adolescents hiv hiv-1 treatment experienced