Clinical Trials

MainTitle

B/F/TAF FDC in HIV-1 Infected Virologically Suppressed Adolescents and Children

This study is ongoing, but not recruiting participants.
Sponsor
Gilead Sciences


Information provided by (Responsible Party)
Gilead Sciences
ClinicalTrials.gov Identifier
NCT02881320

First received: August 23, 2016
Last updated: August 28, 2017
Last Verified: August 2017
History of Changes
Purpose

Purpose

The primary objectives of this study are to evaluate the steady state pharmacokinetics (PK) for bictegravir (GS-9883) and confirm the dose of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) fixed-dose combination (FDC) in HIV-1 infected, virologically suppressed adolescents (12 to < 18 years of age) and children (6 to < 12 years of age). This study will also evaluate the safety and tolerability of B/F/TAF FDC through Week 24 in HIV-1 infected, virologically suppressed adolescents and children.

Condition Intervention Phase
HIV-1 Infection

Drug : B/F/TAF
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the GS-9883/Emtricitabine/Tenofovir Alafenamide (GS-9883/F/TAF) Fixed Dose Combination (FDC) in HIV-1 Infected Virologically Suppressed Adolescents and Children

Further study details as provided by Gilead Sciences:

Primary Outcome Measures

  • PK Parameter: AUCtau of Bictegravir [ Time Frame: Week 2 or Week 4 ]
    AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
  • PK Parameter: Ctau of Bictegravir [ Time Frame: Week 2 or Week 4 ]
    Ctau is defined as the observed drug concentration at the end of the dosing interval.
  • Incidence of Treatment-Emergent Adverse Events (AEs) Through Week 24 [ Time Frame: Up to 24 weeks ]
  • Incidence of Treatment-Emergent Laboratory Abnormalities Through Week 24 [ Time Frame: Up to 24 weeks ]
Secondary Outcome Measures:
  • Proportion of Participants with Plasma HIV-1 RNA < 50 copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm [ Time Frame: Week 24 ]
  • Proportion of Participants with Plasma HIV-1 RNA < 50 copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm [ Time Frame: Week 48 ]
  • Change from Baseline in CD4+ Cell Counts at Week 24 [ Time Frame: Week 24 ]
  • Change from Baseline in CD4+ Cell Counts at Week 48 [ Time Frame: Week 48 ]
  • Change from Baseline in CD4+ Cell Count Percentages at Week 24 [ Time Frame: Week 24 ]
  • Change from Baseline in CD4+ Cell Count Percentages at Week 48 [ Time Frame: Week 48 ]
  • PK Parameter: Tmax of Bictegravir [ Time Frame: Week 2 or Week 4 ]
    Tmax is defined as the time (observed time point) of Cmax.
  • PK Parameter: Cmax of Bictegravir [ Time Frame: Week 2 or Week 4 ]
    Cmax is defined as the maximum observed concentration of drug.
  • Incidence of Treatment-Emergent AEs Through Week 48 [ Time Frame: Up to 48 weeks ]
  • Incidence of All Treatment-Emergent Laboratory Abnormalities Through Week 48 [ Time Frame: Up to 48 weeks ]
  • Acceptability/Palatability of Adult B/F/TAF Formulation at Day 1 [ Time Frame: Day 1 ]
    Participants will be asked if the study drug was palatable and if they were able to take the dosage form.
  • Acceptability/Palatability of Adult B/F/TAF Formulation at Week 4 [ Time Frame: Week 4 ]
    Participants will be asked if the study drug was palatable and if they were able to take the dosage form.

Estimated Enrollment: 100
Study Start Date: September 21, 2016
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: B/F/TAF
Cohort 1 (12 to < 18 years of age ≥ 35 kg) Part A: Participate in an Intensive PK evaluation at Week 2 or Week 4 and continue to receive B/F/TAF 50/200/25 mg FDC through Week 48. Part B: Following confirmation of PK data from Cohort 1 Part A, participants will receive B/F/TAF 50/200/25 mg FDC through Week 48. Cohort 2 (6 to < 12 years of age ≥ 25 kg) Part A: Participate in an Intensive PK evaluation at Week 2 or Week 4 and continue to receive B/F/TAF 50/200/25 mg FDC through Week 48. Part B: Following confirmation of PK data from Cohort 2 Part A, participants will receive B/F/TAF 50/200/25 mg FDC through Week 48.
Drug: B/F/TAF

Tablet administered orally once daily without regard to food

Other Name: GS-9883/F/TAF
Experimental: Open-Label Extension
Following Week 48, participants in countries where B/F/TAF is not available may have the option to receive B/F/TAF FDC until it becomes available for use according to the participant's age and weight or the product becomes accessible to participants through an access program.
Drug: B/F/TAF

Tablet administered orally once daily without regard to food

Other Name: GS-9883/F/TAF
Eligibility

Eligibility

Ages Eligible for Study: 6 Years to 17 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Key Inclusion Criteria:

  • HIV-1 infected adolescents and children who are virologically suppressed for ≥ 6 months on a stable regimen
  • Cohort 1 only: 12 to < 18 years old and weight at screening ≥ 35 kg (77 lbs)
  • Cohort 2 only: 6 to < 12 years old and weight at screening ≥ 25 kg (55 lbs)
  • Documented plasma HIV-1 RNA < 50 copies/mL on a stable regimen (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL) for ≥ 6 months preceding the Screening visit. Unconfirmed virologic elevations of ≥ 50 copies/mL (transient detectable viremia, or "blip") prior to screening are acceptable. If the lower limit of detection of the local HIV-1 RNA assay is < 50 copies/mL (eg, < 20 copies/mL), the plasma HIV-1 RNA level cannot exceed 50 copies/mL on two consecutive HIV-1 RNA tests.
  • Stable antiretroviral regimen of 2 nucleoside reverse transcriptase inhibitors (NRTIs) in combination with a third agent for a minimum of 6 months prior to the screening visit. Individuals undergoing dose modifications to their antiretroviral regimen for growth or who are switching medication formulation(s) are considered to be on a stable antiretroviral regimen.
  • Estimated glomerular filtration rate (GFR) ≥ 90 mL/min/1.73 m^2 according to the Schwartz Formula
  • No documented or suspected resistance to emtricitabine (FTC), tenofovir (TFV), or
integrase strand transfer inhibitors (INSTIs) including, but not limited to, the reverse transcriptase resistance mutations K65R and M184V/I
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: NCT02881320

Locations

United States, District of Columbia
Washington, D.C., District of Columbia, United States, 20010
United States, Florida
Fort Pierce, Florida, United States, 34982
Jacksonville, Florida, United States, 32209
Tampa, Florida, United States, 33606
United States, Georgia
Atlanta, Georgia, United States, 30322
United States, Michigan
Troy, Michigan, United States, 48201
United States, New York
New York, New York, United States, 10016
United States, North Carolina
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19134
United States, Tennessee
Memphis, Tennessee, United States, 38105
South Africa
Bloemfontein, South Africa, 9301
Cape Town, South Africa, 7646
CapeTown, South Africa, 7505
Dundee, South Africa, 3000
Durban, South Africa, 4302
Johannesburg, South Africa, 2092
Johannesburg, South Africa, 2112
Pretoria, South Africa, 0089
Soweto, South Africa, 2013
Thailand
Bangkok, Thailand, 10330
Bangkok, Thailand, 10700
Khon Kaen, Thailand, 40002
Uganda
Kampala, Uganda

Sponsors and Collaborators

Gilead Sciences

Investigators

Study Director: Gilead Study Director Gilead Sciences
More Information

More Information


Responsible Party: Gilead Sciences  
ClinicalTrials.gov Identifier: NCT02881320   History of Changes  
Other Study ID Numbers: GS-US-380-1474  
  2016-002345-39  
Study First Received: August 23, 2016  
Last Updated: August 28, 2017  

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

ClinicalTrials.gov processed this data on December 12, 2017
This information is provided by ClinicalTrials.gov.