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Nucleoside/nucleotide reverse transcriptase inhibitor

F/TAF for HIV-Controlled Pediatric Patients

Phase 2 & 3
Waitlist Available
Research Sponsored by Gilead Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Body weight at screening: Cohort 1 - ≥ 35 kg, Cohort 2, Group 1 - ≥ 25 kg, Cohort 2, Group 2 - 17 kg to < 25 kg, Cohort 3 and 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up any time at week 2 or week 4 visit, or within 7 days after the completion of week 2 or week 4 visits
Awards & highlights

Study Summary

This trial is studying the safety and effectiveness of a new HIV drug in children and adolescents who are already taking other HIV drugs and have had their HIV infection controlled for at least six months.

Who is the study for?
This trial is for HIV-1 infected children and adolescents aged 1 month to under 18 years, who have been virologically suppressed on a stable NRTI regimen with a third ARV agent for at least 6 months. They must weigh enough according to their cohort's requirements and not be pregnant or breastfeeding. Participants cannot join if they've had significant drug allergies, opportunistic infections within the last month, active serious infections requiring antibiotics, tuberculosis within the last three months, or any condition that might interfere with the study.Check my eligibility
What is being tested?
The study tests F/TAF in combination with a third antiretroviral (ARV) agent and boosted protease inhibitors (PIs) in young patients already responding well to HIV treatment. It aims to confirm appropriate dosing of TAF by examining its levels in the body as well as assessing safety and how well it's tolerated over time.See study design
What are the potential side effects?
Potential side effects may include digestive issues like nausea or diarrhea, headaches, fatigue, skin rashes, and changes in liver enzymes which could indicate liver problems. There might also be risks related to bone density loss or kidney function changes due to long-term use of these medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My body weight fits the trial's specific group requirements.
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I have been on a stable HIV medication regimen for at least 6 months.
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I haven't had any serious infections in the last 30 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~any time at week 2 or week 4 visit, or within 7 days after the completion of week 2 or week 4 visits
This trial's timeline: 3 weeks for screening, Varies for treatment, and any time at week 2 or week 4 visit, or within 7 days after the completion of week 2 or week 4 visits for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
PK Parameter (Cohort 2): AUCtau of TAF
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Through Week 24
Pharmacokinetic (PK) Parameter (Cohort 1): AUCtau of Tenofovir Alafenamide (TAF)
Secondary outcome measures
Change From Baseline in CD4 Percentage at Week 24
Change From Baseline in CD4 Percentage at Week 48
Change From Baseline in CD4+ Cell Count at Week 24
+18 more

Trial Design

10Treatment groups
Experimental Treatment
Group I: FTC/TAF+3rd ARV agent (Cohort 4, Part B)Experimental Treatment2 Interventions
Screening will be initiated for Part B following confirmation of TAF dose in Part A. Approximately 10 additional total participants will be enrolled across all Part B cohorts and will receive F/TAF while continuing their 3rd ARV agent through 48 weeks.
Group II: FTC/TAF+3rd ARV agent (Cohort 4, Part A)Experimental Treatment2 Interventions
Participants between 1 month to < 2 years of age will receive F/TAF plus a 3rd ARV agent through 48 weeks.
Group III: FTC/TAF+3rd ARV agent (Cohort 3, Part B)Experimental Treatment2 Interventions
Screening will be initiated for Part B following confirmation of TAF dose in Part A. Approximately 10 additional total participants will be enrolled across all Part B cohorts and will receive F/TAF while continuing their 3rd ARV agent through 48 weeks.
Group IV: FTC/TAF+3rd ARV agent (Cohort 3, Part A)Experimental Treatment2 Interventions
Participants between 2 to < 6 years of age will receive F/TAF plus a 3rd ARV agent through 48 weeks.
Group V: FTC/TAF +3rd ARV agent (Extension Phase)Experimental Treatment2 Interventions
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 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.
Group VI: F/TAF+3rd ARV agent (Cohort 2, Group 2, Part B)Experimental Treatment2 Interventions
Screening will be initiated for Part B following confirmation of TAF dose in Part A. Approximately 10 additional total participants will be enrolled across all Part B cohorts and will receive F/TAF while continuing their 3rd ARV agent through 48 weeks.
Group VII: F/TAF+3rd ARV agent (Cohort 2, Group 2, Part A)Experimental Treatment2 Interventions
Participants between 2 to < 12 years of age and between 17 kg to < 25 kg in body weight must be on a boosted protocol specified 3rd ARV agent and will switch their current 2-NRTI containing regimen to F/TAF 120/15 mg while continuing their 3rd ARV agent for 48 weeks.
Group VIII: F/TAF+3rd ARV agent (Cohort 2, Group 1, Part B)Experimental Treatment2 Interventions
Screening will be initiated for Part B following confirmation of TAF dose in Part A. Approximately 10 additional total participants will be enrolled across all Part B cohorts and will receive F/TAF while continuing their 3rd ARV agent through 48 weeks.
Group IX: F/TAF+3rd ARV agent (Cohort 2, Group 1, Part A)Experimental Treatment2 Interventions
Participants between 6 to < 12 years of age and ≥ 25 kg in body weight must be on a boosted protease inhibitor (PI) as their 3rd ARV agent and will switch their current 2-NRTI regimen to F/TAF 200/25 mg while continuing on their boosted PI for 48 weeks.
Group X: F/TAF+3rd ARV agent (Cohort 1)Experimental Treatment2 Interventions
Participants between 12 to < 18 years of age and ≥ 35 kg in body weight will switch their current 2-NRTI containing regimen to F/TAF (200/25 mg for unboosted 3rd agent and 200/10 mg for boosted 3rd agent) while continuing on their 3rd ARV agent for 48 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
F/TAF
2019
Completed Phase 3
~2770
3rd ARV agent
2015
Completed Phase 3
~570

Find a Location

Who is running the clinical trial?

Gilead SciencesLead Sponsor
1,077 Previous Clinical Trials
837,512 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
341 Previous Clinical Trials
185,787 Total Patients Enrolled

Media Library

Emtricitabine/Tenofovir Alafenamide (F/TAF) (Nucleoside/nucleotide reverse transcriptase inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02285114 — Phase 2 & 3
HIV Research Study Groups: F/TAF+3rd ARV agent (Cohort 1), F/TAF+3rd ARV agent (Cohort 2, Group 1, Part A), F/TAF+3rd ARV agent (Cohort 2, Group 2, Part A), FTC/TAF+3rd ARV agent (Cohort 3, Part A), FTC/TAF+3rd ARV agent (Cohort 4, Part A), F/TAF+3rd ARV agent (Cohort 2, Group 1, Part B), F/TAF+3rd ARV agent (Cohort 2, Group 2, Part B), FTC/TAF+3rd ARV agent (Cohort 3, Part B), FTC/TAF+3rd ARV agent (Cohort 4, Part B), FTC/TAF +3rd ARV agent (Extension Phase)
HIV Clinical Trial 2023: Emtricitabine/Tenofovir Alafenamide (F/TAF) Highlights & Side Effects. Trial Name: NCT02285114 — Phase 2 & 3
Emtricitabine/Tenofovir Alafenamide (F/TAF) (Nucleoside/nucleotide reverse transcriptase inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02285114 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this study have an age limit? If so, what is the cut-off age?

"The age bracket that this trial is recruiting from is 1 month old to 17 years old."

Answered by AI

Are there any available positions for people who want to participate in this trial?

"According to the clinicaltrials.gov website, this clinical trial is not currently recruiting patients. The trial was first posted on 1/20/2015, and the most recent update was on 4/26/2022. Although this trial is not looking for patients right now, there are 9 other studies that are."

Answered by AI

Are there restrictions on who is able to be a part of this research project?

"This study is looking for 41 HIV-1 positive participants between the ages of 1 month and 17 years old. Patients must meet the following criteria: 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, 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, Cohort 2, Group 2: 17 kg to <"

Answered by AI

Which medical centers offer this particular clinical trial?

"Children's Hospital Colorado in Aurora, Colorado, St. Christopher's Hospital for Children in Philadelphia, Pennsylvania, Seattle Children's Hospital in Seattle, Washington, and 4 other sites are conducting this trial."

Answered by AI
~4 spots leftby Mar 2025