Clinical Trials

MainTitle

Emtricitabine/Tenofovir Alafenamide (F/TAF) in HIV-1 Infected Children and Adolescents Virologically Suppressed on a 2-NRTI-Containing Regimen

This study is currently recruiting participants. (see Contacts and Locations)

Verified November 2017 by Gilead Sciences

Sponsor
Gilead Sciences


Information provided by (Responsible Party)
Gilead Sciences
ClinicalTrials.gov Identifier
NCT02285114

First received: November 4, 2014
Last updated: November 10, 2017
Last Verified: November 2017
History of Changes
Purpose

Purpose

This study will evaluate the pharmacokinetics (PK), safety, and efficacy of emtricitabine/tenofovir alafenamide (F/TAF) in HIV-1 infected children and adolescents virologically suppressed (defined as having < 50 copies/mL of HIV-1 RNA for a period of at least 6 months) while on a stable 2-nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) containing regimen.

Condition Intervention Phase
HIV-1

Drug : F/TAF
Drug : 3rd ARV agent
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Gilead Sciences:

Primary Outcome Measures

  • PK parameter of tenofovir alafenamide (TAF) as measured by AUClast [ Time Frame: Predose and postdose on Week 2 ]
  • Incidence of treatment-emergent serious adverse events (SAEs) and all treatment-emergent adverse events (AEs) [ Time Frame: Up to 48 weeks plus 30 days ]
    Incidence of SAEs and AEs will be summarized.
Secondary Outcome Measures:
  • PK profiles of TAF, emtricitabine (FTC), and tenofovir (TFV) [ Time Frame: Predose and postdose on Weeks 4 and 12 ]
    This endpoint will measure the plasma PK profiles of TAF, FTC, and TFV. The following parameters will be measured, as applicable: TAF: Cmax, Clast, Cl/F, and Vz /F FTC and TFV: TAF, AUCtau, Cmax, and Ctau
  • Percentage of participants with HIV 1 RNA < 50 copies/mL as defined by the FDA snapshot algorithm [ Time Frame: Week 24; Week 48 ]
  • Change from baseline in CD4+ cell count (cells/μL) and CD4+ percentage [ Time Frame: Week 24; Week 48 ]

Estimated Enrollment: 100
Study Start Date: January 20, 2015
Estimated Study Completion Date: December 2024
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: F/TAF+3rd ARV agent (Cohort 1)
Participants between 12 to < 18 years of age will switch their current 2-NRTI containing regimen to F/TAF while continuing on their 3rd ARV agent for 48 weeks.
Drug: F/TAF

F/TAF tablets administered orally once daily

Other Name: Descovy®
Drug: 3rd ARV agent

A 3rd antiretroviral (ARV) agent of the participant's pre-existing regimen may include one of the following: boosted atazanavir (ATV), boosted lopinavir (LPV), boosted darunavir (DRV), efavirenz (EFV), nevirapine (NVP), raltegravir (RAL), or dolutegravir (DTG). Cohort 2, Group 1 will receive only boosted PIs (ATV, LPV or DRV).

Experimental: F/TAF+3rd ARV agent (Cohort 2, Group 1, Part A)
Participants between 6 to < 12 years of age must be on a boosted protease inhibitor (PI) as their 3rd ARV agent and will switch their current 2-NRTI regimen to F/TAF while continuing on their boosted PI for 48 weeks.
Drug: F/TAF

F/TAF tablets administered orally once daily

Other Name: Descovy®
Drug: 3rd ARV agent

A 3rd antiretroviral (ARV) agent of the participant's pre-existing regimen may include one of the following: boosted atazanavir (ATV), boosted lopinavir (LPV), boosted darunavir (DRV), efavirenz (EFV), nevirapine (NVP), raltegravir (RAL), or dolutegravir (DTG). Cohort 2, Group 1 will receive only boosted PIs (ATV, LPV or DRV).

Experimental: F/TAF+3rd ARV agent (Cohort 2, Group 2, Part A)
Participants between 2 to < 12 years of age must be on a boosted protease inhibitor (PI) or other protocol specified 3rd ARV agent and will switch their current 2-NRTI containing regimen to F/TAF while continuing their 3rd ARV agent for 48 weeks.
Drug: F/TAF

F/TAF tablets administered orally once daily

Other Name: Descovy®
Drug: 3rd ARV agent

A 3rd antiretroviral (ARV) agent of the participant's pre-existing regimen may include one of the following: boosted atazanavir (ATV), boosted lopinavir (LPV), boosted darunavir (DRV), efavirenz (EFV), nevirapine (NVP), raltegravir (RAL), or dolutegravir (DTG). Cohort 2, Group 1 will receive only boosted PIs (ATV, LPV or DRV).

Experimental: 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.
Drug: F/TAF

F/TAF tablets administered orally once daily

Other Name: Descovy®
Drug: 3rd ARV agent

A 3rd antiretroviral (ARV) agent of the participant's pre-existing regimen may include one of the following: boosted atazanavir (ATV), boosted lopinavir (LPV), boosted darunavir (DRV), efavirenz (EFV), nevirapine (NVP), raltegravir (RAL), or dolutegravir (DTG). Cohort 2, Group 1 will receive only boosted PIs (ATV, LPV or DRV).

Experimental: 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.
Drug: F/TAF

F/TAF tablets administered orally once daily

Other Name: Descovy®
Drug: 3rd ARV agent

A 3rd antiretroviral (ARV) agent of the participant's pre-existing regimen may include one of the following: boosted atazanavir (ATV), boosted lopinavir (LPV), boosted darunavir (DRV), efavirenz (EFV), nevirapine (NVP), raltegravir (RAL), or dolutegravir (DTG). Cohort 2, Group 1 will receive only boosted PIs (ATV, LPV or DRV).

Experimental: F/TAF+3rd ARV agent (Cohort 2, Group 1, 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.
Drug: F/TAF

F/TAF tablets administered orally once daily

Other Name: Descovy®
Drug: 3rd ARV agent

A 3rd antiretroviral (ARV) agent of the participant's pre-existing regimen may include one of the following: boosted atazanavir (ATV), boosted lopinavir (LPV), boosted darunavir (DRV), efavirenz (EFV), nevirapine (NVP), raltegravir (RAL), or dolutegravir (DTG). Cohort 2, Group 1 will receive only boosted PIs (ATV, LPV or DRV).

Experimental: F/TAF+3rd ARV agent (Cohort 2, Group 2, 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.
Drug: F/TAF

F/TAF tablets administered orally once daily

Other Name: Descovy®
Drug: 3rd ARV agent

A 3rd antiretroviral (ARV) agent of the participant's pre-existing regimen may include one of the following: boosted atazanavir (ATV), boosted lopinavir (LPV), boosted darunavir (DRV), efavirenz (EFV), nevirapine (NVP), raltegravir (RAL), or dolutegravir (DTG). Cohort 2, Group 1 will receive only boosted PIs (ATV, LPV or DRV).

Experimental: 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.
Drug: F/TAF

F/TAF tablets administered orally once daily

Other Name: Descovy®
Drug: 3rd ARV agent

A 3rd antiretroviral (ARV) agent of the participant's pre-existing regimen may include one of the following: boosted atazanavir (ATV), boosted lopinavir (LPV), boosted darunavir (DRV), efavirenz (EFV), nevirapine (NVP), raltegravir (RAL), or dolutegravir (DTG). Cohort 2, Group 1 will receive only boosted PIs (ATV, LPV or DRV).

Experimental: 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.
Drug: F/TAF

F/TAF tablets administered orally once daily

Other Name: Descovy®
Drug: 3rd ARV agent

A 3rd antiretroviral (ARV) agent of the participant's pre-existing regimen may include one of the following: boosted atazanavir (ATV), boosted lopinavir (LPV), boosted darunavir (DRV), efavirenz (EFV), nevirapine (NVP), raltegravir (RAL), or dolutegravir (DTG). Cohort 2, Group 1 will receive only boosted PIs (ATV, LPV or DRV).

Detailed Description:

Cohorts 2, 3, and 4 will be on a boosted protease inhibitor (PI) or any other 3rd ARV agent and will switch their current 2-NRTI-containing regimen to open-label F/TAF while continuing their boosted PI or 3rd 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. Participants in Cohort 2, Group 1 receive boosted PI agents only. 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.

Eligibility

Eligibility

Ages Eligible for Study: 1 Month to 17 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Key Inclusion Criteria:

  • 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-NRTI containing regimen that includes a 3rd ARV agent for ≥ 6 consecutive months prior to screening
  • Plasma HIV-1 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

  • 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 tenofovir, within 30 days prior to the study dosing
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02285114

Contacts

Contact:   Gilead Study Team GS-US-311-1269@gilead.com

Locations

United States, California
UCLA Recruiting
Los Angeles, California, United States, 90095
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States
United States, Pennsylvania
St. Christopher's Hospital, for Children Recruiting
Philadelphia, Pennsylvania, United States, 19134
United States, Tennessee
St. Judes Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States
Panama
Hospital del Nino Recruiting
Panama City, Panama
South Africa
Be Part Yoluntu Centre Recruiting
Cape Town, South Africa
University of Stellenbosch Recruiting
Cape Town, South Africa
Rahima Moosa Mother and Child Hopsital Recruiting
Johannesburg, South Africa
United Kingdom
Imperial College Healthcare NHS Trust- St. Mary's Hospital Not yet recruiting
London, United Kingdom

Sponsors and Collaborators

Gilead Sciences

Investigators

Study Director: Gilead Study Director Gilead Sciences
More Information

More Information


Responsible Party: Gilead Sciences  
ClinicalTrials.gov Identifier: NCT02285114   History of Changes  
Other Study ID Numbers: GS-US-311-1269  
  2015-001339-19  
Study First Received: November 4, 2014  
Last Updated: November 10, 2017  

Studies a U.S. FDA-regulated Drug Product: Yes  
Studies a U.S. FDA-regulated Device Product: No  

Keywords provided by Gilead Sciences:

HIV
emtricitabine
FTC
tenofovir
TDF
TAF
antiretroviral
pharmacokinetic
PK
adolescents
children
pediatric
Gilead

Additional relevant MeSH terms:
Tenofovir
Emtricitabine
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Protease Inhibitors

ClinicalTrials.gov processed this data on December 08, 2017
This information is provided by ClinicalTrials.gov.