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
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
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 children and adolescents with HIV-1 who are 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 2 NRTI containing regimen.
Full description
A minimum of 100 participants in total (across all cohorts) aged 1 month to <18 years of age will be enrolled to receive F/TAF. The study will proceed in sequential cohorts as follows: Cohort 1 will switch their current 2-NRTI-containing regimen to F/TAF while continuing on their 3rd ARV agent through 48 weeks; Cohorts 2, 3, and 4 must be on a boosted protease inhibitor (PI) (Cohort 2 only) or any other 3rd ARV agent and will switch their current 2-NRTI-containing regimen to F/TAF while continuing their boosted PI or 3rd ARV 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-ATV as their 3rd ARV agent will be enrolled. 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.
However, Cohort 2 (Part B), Cohorts 3 and 4 were not conducted as planned.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Key Inclusion Criteria:
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Human immunodeficiency virus 1 (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)
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Must be able to give written assent prior to any screening evaluations
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Parent or guardian able to give written informed consent prior to any screening evaluations and willing to comply with study requirements
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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
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Currently on a stable 2-nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) containing regimen that includes a 3rd antiretroviral (ARV) agent for ≥ 6 consecutive months prior to screening
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Plasma HIV-1 ribonucleic acid (RNA) levels < 50 copies/mL for ≥ 6 consecutive months preceding the screening visit
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No opportunistic infection within 30 days of study entry (at baseline/Day 1)
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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 TDF, within 30 days prior to the study dosing
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Trial design
Primary purpose
Allocation
Interventional model
Masking
41 participants in 10 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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