study to evaluate emtricitabine/tenofovir alafenamide (f/taf) in human immunodeficiency virus 1 (hiv-1) infected children and adolescents virologically suppressed on a 2- nucleoside/nucleotide reverse transcriptase inhibitor (2-nrti)-containing regimen

Conditions: HIV-1

Summary: the primary objective of this study is to confirm the taf dose and to evaluate the pharmacokinetics (pk) of taf, safety, and tolerability of f/taf in hiv-1 infected children and adolescents virologically suppressed (defined as having \< 50 copies/ml of hiv-1 ribonucleic acid \[rna\] for a period of at least 6 months) while on a stable nrti containing regimen.

cohorts 2, 3, and 4 will be on a boosted protease inhibitor (pi) or any other 3rd antiretroviral (arv) agent and will switch their current 2-nrti-containing regimen to open-label f/taf while continuing their boosted pi or 3rd agent through 48 weeks. a minimum of 10 participants each in groups 1 and 2 of cohort 2, and cohorts 3 and 4, who are on boosted-atazanavir (atv) as their 3rd arv agent will be enrolled. participants in cohort 2, group 1 receive boosted pi agents only. cohorts 2, 3, and 4 will be enrolled by cohort into a two-part study (parts a and b). after completion of 48 weeks, all participants will be given the option to participate in an extension phase of the study. gilead will provide f/taf until a) the participant turns 18 years old and f/taf is commercially available for use in adults in the country in which the participant is enrolled or b), f/taf becomes commercially available for pediatric use in the country in which the participant is enrolled or c), gilead sciences elects to terminate development of f/taf in the applicable country.

Eligibility criteria:
key inclusion criteria: * hiv-1 infected male and female adolescents and children aged 1 month to \< 18 years at baseline/day 1 (according to requirements of the enrolling cohort) * must be able to give written assent prior to any screening evaluations * parent or guardian able to give written informed consent prior to any screening evaluations and willing to comply with study requirements * body weight at screening as follows: * cohort 1: ≥ 35 kg * cohort 2, group 1: ≥ 25 kg * cohort 2, group 2: 17 kg to \< 25 kg * cohort 3: to be updated per a protocol amendment * cohort 4: to be updated per a protocol amendment * currently on a stable 2-nrti containing regimen that includes a 3rd arv agent for ≥ 6 consecutive months prior to screening * plasma hiv-1 rna levels \< 50 copies/ml for ≥ 6 consecutive months preceding the screening visit * no opportunistic infection within 30 days of study entry (at baseline/day 1) * a negative serum β-human chorionic gonadotropin (hcg) pregnancy test is required for females of childbearing potential only key exclusion criteria: * an acquired immunodeficiency syndrome (aids) - indicator condition with onset within 30 days prior to screening * life expectancy of \< 2 years * active, serious infections (other than hiv-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline/day 1 * evidence of active pulmonary or extra-pulmonary tuberculosis disease within 3 months of the screening visit * active hepatitis c virus (hcv) infection defined as positive for hcv antibody and having detectable hcv rna * positive hepatitis b surface antigen or other evidence of active hepatitis b virus (hbv) infection. * have any serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with treatment, assessment, or compliance with the protocol. * pregnant or lactating females * have history of significant drug sensitivity or drug allergy * have previously participated in an investigational trial involving administration of any investigational agent, other than tenofovir, within 30 days prior to the study dosing note: other protocol defined inclusion/ exclusion criteria may apply.

Keywords: emtricitabine ftc tenofovir tdf antiretroviral adolescents children pediatric