STATUS Study Complete

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

Gilead Clinical Study Information Center:
Monday – Friday, 5am – 6pm PT
Email: [email protected]

STATUS

Study Complete

GILEAD STUDY ID

GS-US-311-1269

Gilead Clinical Study Information Center:
Monday – Friday, 5am – 6pm PT
Email: [email protected]

LAST UPDATED

June 27, 2025

Clinicaltrials.gov ID

NCT02285114

EudraCT ID

2015-001339-19

STUDY DOCUMENTS

View study documents

OVERVIEW

A Phase 2/3, Open-Label, Multi-Cohort Switch Study to Evaluate Emtricitabine/Tenofovir Alafenamide (F/TAF) in HIV-1 Infected Children and Adolescents Virologically Suppressed on a 2-NRTI-Containing Regimen

PROTOCOL 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 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.

Participation requirements

Age

1 Month - 17 years

Sex

All

Healthy Volunteers

Study details

Medical Condition

HIV-1

Gender

N/A

Date

January 2015 - November 2019

Study Type

Interventional

Study Phase

Phase 2, Phase 3

Product

F/TAF, 3rd ARV agent, Boosted PIs

Eligibility information

Inclusion criteria

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)
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-nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) containing regimen that includes a 3rd antiretroviral (ARV) agent for ≥ 6 consecutive months prior to screening
Plasma HIV-1 ribonucleic acid (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

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.