Clinical trial NCT01854775: Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents and Virologically Suppressed Children
Official title: A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents and Virologically Suppressed Children
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Acquired Immune Deficiency Syndrome (AIDS)
HIV Infections
Keywords: Adolescents
HIV-1
HIV
Treatment-naive
Virologically suppressed
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2013-05-16
Enrollment: 129
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objectives of Cohort 1 are to evaluate the steady state pharmacokinetics (PK) for elvitegravir (EVG) and tenofovir alafenamide (TAF) and confirm the dose of the elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) STR (Part A) and to evaluate the safety and tolerability of E/C/F/TAF STR through Week 24 (Part B) in human immunodeficiency virus - 1 (HIV-1) infected, antiretroviral (ARV) treatment-naive adolescents.

The primary objectives of Cohort 2 are to evaluate the PK of EVG and TAF in virologically suppressed HIV-1 infected children 6 to \< 12 years of age weighing ≥ 25 kg administered E/C/F/TAF STR (Part A) and to evaluate the safety and tolerability of E/C/F/TAF STR through Week 24 in virologically suppressed HIV-1 infected children 6 to \< 12 years of age weighing ≥ 25 kg (Part B).

The primary objectives of Cohort 3 are to evaluate the PK of EVG and TAF and confirm the dose of the STR, and to evaluate the safety and tolerability of E/C/F/TAF low dose (LD) STR in virologically suppressed HIV-1 infected children ≥ 2 years of age and weighing ≥ 14 to \< 25 kg.


Eligibility criteria: Key Inclusion Criteria:

* Cohort 1

  * 12 years to \< 18 years of age at baseline
  * Weight greater than or equal to 35 kg (77 lbs)
  * Plasma HIV-1 ribonucleic acid (RNA) levels of ≥ 1,000 copies/mL at screening (Roche COBAS TaqMan v2.0)
  * Screening genotype report shows sensitivity to EVG, FTC and tenofovir (TFV)
  * No prior use of any approved or experimental anti-HIV-1 drug for any length of time
* Cohort 2

  * 6 years to \< 12 years of age at baseline
  * Weight greater than or equal to 25 kg (55 lbs)
  * Plasma HIV-1 RNA of \< 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is \> 50 copies/mL) for ≥ 180 consecutive days (6 months) prior to screening on a stable antiretroviral regimen, without documented history of resistance to any component of E/C/F/TAF STR.
* Cohort 3

  * Age at baseline: ≥ 2 years old
  * Weight at screening: ≥ 14 kg (31 lbs) to \< 25 kg (55 lbs)
  * Plasma HIV-1 RNA: \< 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is \> 50 copies/mL) for ≥ 180 consecutive days (6 months) prior to screening on a stable antiretroviral regimen, without prior history of resistance to any component of E/C/F/TAF STR

Key Exclusion Criteria:

* Hepatitis B or hepatitis C virus infection
* Evidence of active pulmonary or extra-pulmonary tuberculosis disease within 3 months of the screening visit.
* Individuals experiencing decompensated cirrhosis
* Pregnant or lactating females

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Pharmacokinetic (PK) Parameter: AUCtau of Elvitegravir (EVG) (Cohort 1)
timeFrame: 0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4
measure: PK Parameter: AUCtau of EVG (Cohort 2)
timeFrame: 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4
measure: PK Parameter: AUCtau of EVG (Cohort 3)
timeFrame: 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2
measure: PK Parameter: AUClast of Tenofovir Alafenamide (TAF) (Cohort 1)
timeFrame: 0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4
measure: PK Parameter: AUClast of TAF (Cohort 2)
timeFrame: 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4
measure: PK Parameter: AUCtau of TAF (Cohort 3)
timeFrame: 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2
measure: Cohort 1: Percentage of Participants With All Treatment-Emergent Adverse Events (AEs) and Treatment-Emergent Serious Adverse Events (SAEs)
timeFrame: From first dose date up to Week 24
measure: Cohort 2: Percentage of Participants With All Treatment-Emergent AEs and Treatment-Emergent SAEs
timeFrame: From first dose date up to Week 24
measure: Cohort 3: Percentage of Participants With All Treatment-Emergent AEs and Treatment-Emergent SAEs
timeFrame: From first dose date up to Week 24
Secondary outcomes:
measure: PK Parameter: Ctau of EVG, FTC, TFV, and COBI (Cohort 1)
timeFrame: 0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4
measure: PK Parameter: Ctau of EVG, FTC, TFV, and COBI (Cohort 2)
timeFrame: (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4
measure: PK Parameter: Ctau of EVG, FTC, TFV, and COBI (Cohort 3)
timeFrame: 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2
measure: PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 1)
timeFrame: 0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4
measure: PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 2)
timeFrame: 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4
measure: PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 3)
timeFrame: 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2
measure: PK Parameter: CL of EVG and TAF (Cohort 1)
timeFrame: 0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4
measure: PK Parameter: CL of EVG and TAF (Cohort 2)
timeFrame: 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4
measure: PK Parameter: CL of EVG and TAF (Cohort 3)
timeFrame: 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2
measure: PK Parameter: Vz of EVG and TAF (Cohort 1)
timeFrame: 0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4
measure: PK Parameter: Vz of EVG and TAF (Cohort 2)
timeFrame: 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4
measure: PK Parameter: Vz of EVG and TAF (Cohort 3)
timeFrame: 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2
measure: PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 1)
timeFrame: 0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4
measure: PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 2)
timeFrame: 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4
measure: PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 3)
timeFrame: 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2
measure: Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis
timeFrame: Week 24
measure: Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis
timeFrame: Week 48
measure: Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis
timeFrame: Week 24
measure: Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis
timeFrame: Week 48
measure: Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis
timeFrame: Week 24
measure: Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis
timeFrame: Week 48
measure: Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis
timeFrame: Week 24
measure: Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis
timeFrame: Week 48
measure: Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Failure Analyses
timeFrame: Week 24
measure: Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Failure Analyses
timeFrame: Week 48
measure: Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Failure Analyses
timeFrame: Week 24
measure: Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Failure Analyses
timeFrame: Week 48
measure: Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Failure Analyses
timeFrame: Week 24
measure: Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Failure Analyses
timeFrame: Week 24
measure: Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Failure Analyses
timeFrame: Week 24
measure: Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Failure Analyses
timeFrame: Week 48
measure: Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Failure Analyses
timeFrame: Week 24
measure: Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Failure Analyses
timeFrame: Week 48
measure: Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Excluded Analyses
timeFrame: Week 24
measure: Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Excluded Analyses
timeFrame: Week 48
measure: Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Excluded Analyses
timeFrame: Week 24
measure: Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Excluded Analyses
timeFrame: Week 48
measure: Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Excluded Analyses
timeFrame: Week 24
measure: Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Excluded Analyses
timeFrame: Week 48
measure: Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Excluded Analyses
timeFrame: Week 24
measure: Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Excluded Analyses
timeFrame: Week 48
measure: Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Excluded Analyses
timeFrame: Week 24
measure: Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Excluded Analyses
timeFrame: Week 48
measure: Cohort 1: Change From Baseline in Plasma log10 HIV-1 RNA at Week 24
timeFrame: Baseline, Week 24
measure: Cohort 1: Change From Baseline in Plasma log10 HIV-1 RNA at Week 48
timeFrame: Baseline, Week 48
measure: Cohort 1: Change From Baseline in CD4+ Cell Count at Week 24
timeFrame: Baseline, Week 24
measure: Cohort 1: Change From Baseline in CD4+ Cell Count at Week 48
timeFrame: Baseline, Week 48
measure: Cohort 2: Change From Baseline in CD4+ Cell Count at Week 24
timeFrame: Baseline, Week 24
measure: Cohort 2: Change From Baseline in CD4+ Cell Count at Week 48
timeFrame: Baseline, Week 48
measure: Cohort 3: Change From Baseline in CD4+ Cell Count at Week 24
timeFrame: Baseline, Week 24
measure: Cohort 3: Change From Baseline in CD4+ Cell Count at Week 48
timeFrame: Baseline, Week 48
measure: Cohort 1: Change From Baseline in CD4+ Cell Percentage at Week 24
timeFrame: Baseline, Week 24
measure: Cohort 1: Change From Baseline in CD4+ Cell Percentage at Week 48
timeFrame: Baseline, Week 48
measure: Cohort 2: Change From Baseline in CD4+ Cell Percentage at Week 24
timeFrame: Baseline, Week 24
measure: Cohort 2: Change From Baseline in CD4+ Cell Percentage at Week 48
timeFrame: Baseline, Week 48
measure: Cohort 3: Change From Baseline in CD4+ Cell Percentage at Week 24
timeFrame: Baseline, Week 24
measure: Cohort 3: Change From Baseline in CD4+ Cell Percentage at Week 48
timeFrame: Baseline, Week 48
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Miller's Children Hospital
state: California
city: Washington
country: United States
facility: Children's Research Institute
state: District of Columbia
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Cape Town
country: South Africa
facility: KIDCRU Ward J8
city: Cape Town
country: South Africa
facility: Be Part Yoluntu Centre
city: Cape Town
country: South Africa
facility: Desmond Tutu HIV Foundation
city: Johannesburg
country: South Africa
facility: Perinatal HIV Research Unit Baragwanath Hospital
city: Johannesburg
country: South Africa
facility: Clinical HIV Research Unit
city: Johannesburg
country: South Africa
facility: Empilweni Services and Research Unit (ESRU)
city: Bangkok
country: Thailand
facility: The HIV Netherlands Australia Thailand Research collaboration (HIV-NAT)
city: Chon Buri
country: Thailand
facility: Queen Savang Vadhana Memorial Hospital
city: Khon Kaen
country: Thailand
facility: Department of Pediatrics, Faculty of Medicine, Khon Kaen University
city: Kampala
country: Uganda
facility: Joint Clinical Research Centre
city: Belgravia
country: Zimbabwe
facility: University of Zimbabwe - Clinical Research Centre
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
citation: Kizito H, Gaur A, Prasitsuebsai W, Rakhmanina N, Chokephaibulkit K, Fourie J, et al. Changes in renal laboratory markers and bone mineral density in treatment-naïve HIV-1-infected adolescents initiating INSTI-based single-tablet regimens containing tenofovir alafenamide (TAF) or tenofovir disoproxil fumarate (TDF) [Presentation #MOAB0104]. International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention; 2015 19-22 July; Vancouver, Canada.
citation: Rakhmanina N, Gaur A, Natukunda E, Chokephaibulkit K, Liberty A, Kido A, et al. Acceptability and palatability of the single-tablet regimens of B/F/TAF and E/C/F/TAF in children (6-12 years) living with HIV infection [Abstract 33]. 10th International Workshop on HIV Pediatrics; 2018 July 21-22; Amsterdam, The Netherlands
citation: Sharma S, Gupta S, Majeed S, Strehlau R, Hellstrom E, Liu Y, et al. Exposure-Safety of Tenofovir in Pediatric HIV-Infected Participants: Comparison of Tenofovir Alafenamide & Tenofovir Disoproxil Fumarate [Abstract 23]. 10th International Workshop on HIV Pediatrics; 2018 July 21-22; Amsterdam, The Netherlands.
citation: Natukunda E, Gaur AH, Kosalaraksa P, Batra J, Rakhmanina N, Porter D, Shao Y, Zhang H, Pikora C, Rhee MS. Safety, efficacy, and pharmacokinetics of single-tablet elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide in virologically suppressed, HIV-infected children: a single-arm, open-label trial. Lancet Child Adolesc Health. 2017 Sep;1(1):27-34. doi: 10.1016/S2352-4642(17)30009-3. Epub 2017 Jun 29.
citation: Rakhmanina N, Natukunda E, Kosalaraksa P, Batra J, Gaur A, Shao Y, et al. Safety and efficacy of E/C/F/TAF in virologically suppressed, HIV-infected children through 48 weeks [Abstract 32]. 9th International Workshop on HIV Pediatrics; 2017 July 21-22; Paris, France.
citation: Gaur A, Natukunda E, Kosalarksa P, Batra J, Rakhmanina N, Coluci A, et al. Pharmacokinetics, Safety, and Efficacy of E/C/F/TAF in HIV-1-Infected Children (6 to <12 years) [Poster 424]. Conference on Retroviruses and Opportunistic Infections (CROI); 2017 February 13-16; Seattle Washington.
citation: Gaur AH, Kizito H, Prasitsueubsai W, Rakhmanina N, Rassool M, Chakraborty R, Batra J, Kosalaraksa P, Luesomboon W, Porter D, Shao Y, Myers M, Ting L, SenGupta D, Quirk E, Rhee MS. Safety, efficacy, and pharmacokinetics of a single-tablet regimen containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide in treatment-naive, HIV-infected adolescents: a single-arm, open-label trial. Lancet HIV. 2016 Dec;3(12):e561-e568. doi: 10.1016/S2352-3018(16)30121-7. Epub 2016 Oct 17.
citation: Gaur A, Kizito H, Chakraborty R, Batra J, Kosalaraksa P, Luesomboon W, et al. Safety and Efficacy of E/C/F/TAF in HIV-1 Infected Treatment-Naive Adolescents [Poster 817]. Conference on Retroviruses and Opportunistic Infections (CROI); 2016 February 22-25; Boston, Massachusetts.
citation: Natukunda E, Liberty A, Strehlau R, Hellstrom E, Hakim JG, Kaur H, et al. Safety, pharmacokinetics and efficacy of low dose E/C/F/TAF in virologically suppressed children ≥ 2 years old living with HIV. (Abstract OABLB0101) 23rd International AIDS Conference; 06-10 July 2020 (Virtual).
citation: Natukunda E, Liberty A, Strehlau R, Hellstrom E, Hakim J, Kaur H, et al. Safety, pharmacokinetics, and efficacy of low dose E/C/F/TAF in virologically suppressed children ≥ 2 years old living with HIV. (Abstract 3) International Workshop on HIV Pediatrics 2020; 16-17 November 2020 (Virtual).
citation: Liberty A, Strehlau R, Rakhmanina N, Chokephaibulkit K, Koziara J, Kaur H, et al. Acceptability and palatability of low dose B/F/TAF and E/C/F/TAF in children (≥ 2y) with HIV. (Abstract 57) International Workshop on HIV Pediatrics 2020; 16-17 November 2020 (Virtual).
citation: Kizito H, Gaur A, Prasitsuebsai W, Rakhmanina N, Lawson E, Shao Y, et al. Safety, Efficacy and Pharmacokinetics of the Integrase Inhibitor-Based E/C/F/TAF Single-Tablet Regimen in Treatment-Naïve HIV-Infected Adolescents Through 24 Weeks of Treatment [Poster 953]. Conference on Retroviruses and Opportunistic Infections; 2015 February 23-26; Seattle, WA.
citation: Porter DP, Bennett SR, Quirk E, Miller MD, White KL. Lack of Emergent Resistance in HIV-1-Infected Adolescents on Elvitegravir-Based STRs [Poster 952]. Conference on Retroviruses and Opportunistic Infections (CROI); 2015 23-26 February; Seattle, WA.
citation: Kizito H, Gaur A, Prasitsuebsai W, Rakhmanina N, Lawson E, Shao Y, et al. Safety, Efficacy and Pharmacokinetics of the Integrase Inhibitor-Based E/C/F/TAF Single-Tablet Regimen in Treatment-Naïve HIV-Infected Adolescents Through 24 Weeks of Treatment [Poster 36]. 16th International Workshop on Clinical Pharmacology of HIV & Hepatitis Therapy; 2015 26-28 May; Washington, DC.