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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

Must not have

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

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

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't needed IV antibiotics or antifungals for a serious infection in the last 30 days.

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I have not had tuberculosis in the last 3 months.

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I have an active hepatitis C infection.

Timeline

Screening ~ 3 weeks3 visits

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

PK Parameter (Cohort 1): AUCtau of FTC and TFV

PK Parameter (Cohort 1): CL/F of TAF

PK Parameter (Cohort 1): Clast of TAF

+14 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

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

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

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

3rd ARV agent

2015

Completed Phase 3

~570

F/TAF

2019

Completed Phase 3

~2770