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
NCT ID: NCT02285114
Last Updated: 2025-06-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
41 participants
INTERVENTIONAL
2015-01-20
2024-12-11
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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F/TAF+3rd ARV Agent (Cohort 1)
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.
F/TAF
F/TAF tablets administered orally once daily
3rd ARV agent
A 3rd antiretroviral (ARV) agent may include one of the following: allowed boosted 3rd ARV agents: lopinavir (LPV), atazanavir (ATV), darunavir (DRV); Allowed unboosted 3rd ARV agents: efavirenz (EFV), raltegravir (RAL), dolutegravir (DTG), or nevirapine (NVP)
F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 1)
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.
F/TAF
F/TAF tablets administered orally once daily
Boosted PIs
Allowed boosted PIs: LPV, ATV, DRV.
F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2)
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.
F/TAF
F/TAF tablets administered orally once daily
3rd ARV agent
A 3rd antiretroviral (ARV) agent may include one of the following: allowed boosted 3rd ARV agents: lopinavir (LPV), atazanavir (ATV), darunavir (DRV); Allowed unboosted 3rd ARV agents: efavirenz (EFV), raltegravir (RAL), dolutegravir (DTG), or nevirapine (NVP)
FTC/TAF+3rd ARV Agent (Cohort 3, Part A)
Participants between 2 to \< 6 years of age will receive F/TAF plus a 3rd ARV agent through 48 weeks.
F/TAF
F/TAF tablets administered orally once daily
3rd ARV agent
A 3rd antiretroviral (ARV) agent may include one of the following: allowed boosted 3rd ARV agents: lopinavir (LPV), atazanavir (ATV), darunavir (DRV); Allowed unboosted 3rd ARV agents: efavirenz (EFV), raltegravir (RAL), dolutegravir (DTG), or nevirapine (NVP)
FTC/TAF+3rd ARV Agent (Cohort 4, Part A)
Participants between 1 month to \< 2 years of age will receive F/TAF plus a 3rd ARV agent through 48 weeks.
F/TAF
F/TAF tablets administered orally once daily
3rd ARV agent
A 3rd antiretroviral (ARV) agent may include one of the following: allowed boosted 3rd ARV agents: lopinavir (LPV), atazanavir (ATV), darunavir (DRV); Allowed unboosted 3rd ARV agents: efavirenz (EFV), raltegravir (RAL), dolutegravir (DTG), or nevirapine (NVP)
F/TAF+3rd ARV Agent (Cohort 2, Part B - Group 1)
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.
F/TAF
F/TAF tablets administered orally once daily
3rd ARV agent
A 3rd antiretroviral (ARV) agent may include one of the following: allowed boosted 3rd ARV agents: lopinavir (LPV), atazanavir (ATV), darunavir (DRV); Allowed unboosted 3rd ARV agents: efavirenz (EFV), raltegravir (RAL), dolutegravir (DTG), or nevirapine (NVP)
F/TAF+3rd ARV Agent (Cohort 2, Part B - Group 2)
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.
F/TAF
F/TAF tablets administered orally once daily
3rd ARV agent
A 3rd antiretroviral (ARV) agent may include one of the following: allowed boosted 3rd ARV agents: lopinavir (LPV), atazanavir (ATV), darunavir (DRV); Allowed unboosted 3rd ARV agents: efavirenz (EFV), raltegravir (RAL), dolutegravir (DTG), or nevirapine (NVP)
FTC/TAF+3rd ARV Agent (Cohort 3, Part B)
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.
F/TAF
F/TAF tablets administered orally once daily
3rd ARV agent
A 3rd antiretroviral (ARV) agent may include one of the following: allowed boosted 3rd ARV agents: lopinavir (LPV), atazanavir (ATV), darunavir (DRV); Allowed unboosted 3rd ARV agents: efavirenz (EFV), raltegravir (RAL), dolutegravir (DTG), or nevirapine (NVP)
FTC/TAF+3rd ARV Agent (Cohort 4, Part B)
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.
F/TAF
F/TAF tablets administered orally once daily
3rd ARV agent
A 3rd antiretroviral (ARV) agent may include one of the following: allowed boosted 3rd ARV agents: lopinavir (LPV), atazanavir (ATV), darunavir (DRV); Allowed unboosted 3rd ARV agents: efavirenz (EFV), raltegravir (RAL), dolutegravir (DTG), or nevirapine (NVP)
FTC/TAF+3rd ARV Agent (Extension Phase)
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.
F/TAF
F/TAF tablets administered orally once daily
3rd ARV agent
A 3rd antiretroviral (ARV) agent may include one of the following: allowed boosted 3rd ARV agents: lopinavir (LPV), atazanavir (ATV), darunavir (DRV); Allowed unboosted 3rd ARV agents: efavirenz (EFV), raltegravir (RAL), dolutegravir (DTG), or nevirapine (NVP)
Interventions
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F/TAF
F/TAF tablets administered orally once daily
3rd ARV agent
A 3rd antiretroviral (ARV) agent may include one of the following: allowed boosted 3rd ARV agents: lopinavir (LPV), atazanavir (ATV), darunavir (DRV); Allowed unboosted 3rd ARV agents: efavirenz (EFV), raltegravir (RAL), dolutegravir (DTG), or nevirapine (NVP)
Boosted PIs
Allowed boosted PIs: LPV, ATV, DRV.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
1 Month
17 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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University of California Los Angeles
Los Angeles, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States
Seattle Children's Hospital
Seattle, Washington, United States
Hospital del Nino
Panama City, , Panama
Rahima Moosa Mother and Child Hospital
Johannesburg, Coronationville, South Africa
KIDCRU, Ward J8, Tygerberg Children's Hospital
Cape Town, , South Africa
Be Part Yoluntu Centre
Cape Town, , South Africa
Countries
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References
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Chen JS, Saez-Llorens X, Castano E, Patel F, Melvin A, McFarland EJ, et al. Safety, Pharmacokinetics, and Efficacy of FTC/TAF in HIV-Infected Adolescents (12-18 years) [Poster 843]. Conference on Retroviruses and Opportunistic Infections (CROI); 2018 04-07 March; Boston, MA.
Castano E, Deville J, Zuidewind P, Vedder J, German P, Mathias A, et al. PK and Safety of F/TAF With Boosted 3rd Agents in Children With HIV [Abstract 54]. International Workshop on HIV & Pediatrics 2020; 2020 November 16-17 Virtual.
Cox S, Porter D, White K, Graham H, Pikora C, Callebaut C. Tenofovir Alafenamide-Based Regimens: A Pooled Resistance Analysis in Pediatric Participants [Abstract 4]. International Workshop on HIV Pediatrics 2019; 2019 July 19-20; San Francisco, CA.
Rakhmanina N, Cunningham C, Cotton M, Natukunda E, Rodriguez C, Gaur A, et al. Weight Trajectory in Children and Adolescents Who Switched to TAF-Based Regimens [Abstract 56]. International Workshop on HIV & Pediatrics 2020; 2020 November 16-17; Virtual.
Sharma S, Gupta S, Majeed SR, Strehlau R, Hellstrom E, Liu Y, et al. Exposure-Safety of Tenofovir in Pediatric HIV Infected Participants: Comparison of Tenofovir Alafenamide and Tenofovir Disoproxil Fumarate [Abstract 23]. Presented at International Workshop on HIV Pediatrics 2018; 2018 July 20-21; Amsterdam, The Netherlands.
Cotton M, Cunningham C, Natukunda E, Rodriguez C, Gaur A, Kosalaraksa P, et al. Lack of Influence of Pubertal Stage on Safety and TFV Pharmacokinetics in TAF-based Regimens [Abstract 43]. International Workshop on HIV Pediatrics 2019; 2019 July 19-20; San Francisco, CA.
Andreatta K, Cox S, Chokephaibulkit K, Rodriguez C, Liberty A, Natukunda E, et al. Preexisting and Post-Baseline Resistance Analyses in Pooled Pediatric Studies of Emtricitabine/Tenofovir Alafenamide (F/TAF)-Based Antiretroviral Therapy. 12th IAS Conference on HIV Science; 2023 23-26 July; Brisbane, Australia.
Rakhmanina N, Gaur A, Deville JG, Kosalaraksa P, Strehlau R, Natukunda E, et al. Bone Mineral Density in Children With HIV 1 Receiving TAF Based Antiretroviral Therapy [Abstract 948]. Conference on Retroviruses and Opportunistic Infections (CROI); 2024 03-06 March; Denver, CO.
Mujuru H, Strehlau R, Kosalaraksa A, Deville JG, Pan M, Vieira VA, et al. Week 24 Outcomes of F/TAF Plus Cobicistat-Boosted Protease Inhibitors in Children ≥ 2 Years and ≥ 14 kg [Abstract] Presented at Conference on Retroviruses an Opportunistic Infections (CROI); 2025 09-12 March, San Francisco, CA.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan: Interim Analysis
Document Type: Statistical Analysis Plan: Final Analysis
Related Links
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Gilead Clinical Trials Website
Other Identifiers
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2015-001339-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-311-1269
Identifier Type: -
Identifier Source: org_study_id
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