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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01854775




Registration number
NCT01854775
Ethics application status
Date submitted
3/05/2013
Date registered
16/05/2013
Date last updated
16/10/2024

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
2013-002780-26
Secondary ID [2] 0 0
GS-US-292-0106
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acquired Immune Deficiency Syndrome (AIDS) 0 0
HIV Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - E/C/F/TAF
Treatment: Drugs - E/C/F/TAF (Low Dose)

Experimental: Cohort 1: Age 12 to < 18 Years and Weight = 35 kg - HIV-infected, ARV treatment-naive adolescents (12 to \< 18 years of age weighing = 35 kg) will receive E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) once daily for 48 weeks. Participants who complete 48 weeks of study treatment will have the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turns 18 years old and E/C/F/TAF is commercially available for adults in the country in which the participant is enrolled; b) age-appropriate E/C/F/TAF become commercially available in the country in which the participant is enrolled; or c) Gilead elects to terminate development of E/C/F/TAF in that country.

Experimental: Cohort 2: Age 6 to < 12 Years and Weight = 25 kg - Virologically suppressed HIV-infected children (6 to \< 12 years of age weighing = 25 kg) will receive E/C/F/TAF (150/150/200/10 mg) FDC once daily for 48 weeks. Participants who complete 48 weeks of study treatment will have the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turns 18 years old and E/C/F/TAF is commercially available for adults in the country in which the participant is enrolled; b) age-appropriate E/C/F/TAF become commercially available in the country in which the participant is enrolled; or c) Gilead elects to terminate development of E/C/F/TAF in that country.

Experimental: Cohort 3: Age =2 Years and Weight = 14 to <25 kg - Virologically suppressed HIV-infected children (= 2 years of age weighing = 14 to \< 25 kg) will receive E/C/F/TAF (90/90/120/6 mg) FDC once daily for 48 weeks. Participants who attain a weight of = 25 kg during the course of the study will switch to adult E/C/F/TAF (150/150/200/10 mg) tablets. Participants who complete 48 weeks of study treatment will have the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turns 18 years old and E/C/F/TAF is commercially available for adults in the country in which the participant is enrolled; b) age-appropriate E/C/F/TAF became commercially available in the country in which the participant is enrolled; or c) Gilead elects to terminate development of E/C/F/TAF in that country.


Treatment: Drugs: E/C/F/TAF
Tablets administered orally with food.

Treatment: Drugs: E/C/F/TAF (Low Dose)
90/90/120/6 mg STR administered once daily orally with food.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pharmacokinetic (PK) Parameter: AUCtau of Elvitegravir (EVG) (Cohort 1)
Timepoint [1] 0 0
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
Primary outcome [2] 0 0
PK Parameter: AUCtau of EVG (Cohort 2)
Timepoint [2] 0 0
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
Primary outcome [3] 0 0
PK Parameter: AUCtau of EVG (Cohort 3)
Timepoint [3] 0 0
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
Primary outcome [4] 0 0
PK Parameter: AUClast of Tenofovir Alafenamide (TAF) (Cohort 1)
Timepoint [4] 0 0
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
Primary outcome [5] 0 0
PK Parameter: AUClast of TAF (Cohort 2)
Timepoint [5] 0 0
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
Primary outcome [6] 0 0
PK Parameter: AUCtau of TAF (Cohort 3)
Timepoint [6] 0 0
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
Primary outcome [7] 0 0
Cohort 1: Percentage of Participants With All Treatment-Emergent Adverse Events (AEs) and Treatment-Emergent Serious Adverse Events (SAEs)
Timepoint [7] 0 0
From first dose date up to Week 24
Primary outcome [8] 0 0
Cohort 2: Percentage of Participants With All Treatment-Emergent AEs and Treatment-Emergent SAEs
Timepoint [8] 0 0
From first dose date up to Week 24
Primary outcome [9] 0 0
Cohort 3: Percentage of Participants With All Treatment-Emergent AEs and Treatment-Emergent SAEs
Timepoint [9] 0 0
From first dose date up to Week 24
Secondary outcome [1] 0 0
PK Parameter: Ctau of EVG, FTC, TFV, and COBI (Cohort 1)
Timepoint [1] 0 0
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
Secondary outcome [2] 0 0
PK Parameter: Ctau of EVG, FTC, TFV, and COBI (Cohort 2)
Timepoint [2] 0 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
Secondary outcome [3] 0 0
PK Parameter: Ctau of EVG, FTC, TFV, and COBI (Cohort 3)
Timepoint [3] 0 0
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
Secondary outcome [4] 0 0
PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 1)
Timepoint [4] 0 0
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
Secondary outcome [5] 0 0
PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 2)
Timepoint [5] 0 0
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
Secondary outcome [6] 0 0
PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 3)
Timepoint [6] 0 0
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
Secondary outcome [7] 0 0
PK Parameter: CL of EVG and TAF (Cohort 1)
Timepoint [7] 0 0
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
Secondary outcome [8] 0 0
PK Parameter: CL of EVG and TAF (Cohort 2)
Timepoint [8] 0 0
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
Secondary outcome [9] 0 0
PK Parameter: CL of EVG and TAF (Cohort 3)
Timepoint [9] 0 0
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
Secondary outcome [10] 0 0
PK Parameter: Vz of EVG and TAF (Cohort 1)
Timepoint [10] 0 0
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
Secondary outcome [11] 0 0
PK Parameter: Vz of EVG and TAF (Cohort 2)
Timepoint [11] 0 0
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
Secondary outcome [12] 0 0
PK Parameter: Vz of EVG and TAF (Cohort 3)
Timepoint [12] 0 0
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
Secondary outcome [13] 0 0
PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 1)
Timepoint [13] 0 0
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
Secondary outcome [14] 0 0
PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 2)
Timepoint [14] 0 0
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
Secondary outcome [15] 0 0
PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 3)
Timepoint [15] 0 0
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
Secondary outcome [16] 0 0
Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis
Timepoint [16] 0 0
Week 24
Secondary outcome [17] 0 0
Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis
Timepoint [17] 0 0
Week 48
Secondary outcome [18] 0 0
Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis
Timepoint [18] 0 0
Week 24
Secondary outcome [19] 0 0
Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis
Timepoint [19] 0 0
Week 48
Secondary outcome [20] 0 0
Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis
Timepoint [20] 0 0
Week 24
Secondary outcome [21] 0 0
Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis
Timepoint [21] 0 0
Week 48
Secondary outcome [22] 0 0
Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis
Timepoint [22] 0 0
Week 24
Secondary outcome [23] 0 0
Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis
Timepoint [23] 0 0
Week 48
Secondary outcome [24] 0 0
Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Failure Analyses
Timepoint [24] 0 0
Week 24
Secondary outcome [25] 0 0
Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Failure Analyses
Timepoint [25] 0 0
Week 48
Secondary outcome [26] 0 0
Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Failure Analyses
Timepoint [26] 0 0
Week 24
Secondary outcome [27] 0 0
Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Failure Analyses
Timepoint [27] 0 0
Week 48
Secondary outcome [28] 0 0
Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Failure Analyses
Timepoint [28] 0 0
Week 24
Secondary outcome [29] 0 0
Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Failure Analyses
Timepoint [29] 0 0
Week 24
Secondary outcome [30] 0 0
Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Failure Analyses
Timepoint [30] 0 0
Week 24
Secondary outcome [31] 0 0
Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Failure Analyses
Timepoint [31] 0 0
Week 48
Secondary outcome [32] 0 0
Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Failure Analyses
Timepoint [32] 0 0
Week 24
Secondary outcome [33] 0 0
Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Failure Analyses
Timepoint [33] 0 0
Week 48
Secondary outcome [34] 0 0
Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Excluded Analyses
Timepoint [34] 0 0
Week 24
Secondary outcome [35] 0 0
Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Excluded Analyses
Timepoint [35] 0 0
Week 48
Secondary outcome [36] 0 0
Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Excluded Analyses
Timepoint [36] 0 0
Week 24
Secondary outcome [37] 0 0
Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Excluded Analyses
Timepoint [37] 0 0
Week 48
Secondary outcome [38] 0 0
Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Excluded Analyses
Timepoint [38] 0 0
Week 24
Secondary outcome [39] 0 0
Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Excluded Analyses
Timepoint [39] 0 0
Week 48
Secondary outcome [40] 0 0
Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Excluded Analyses
Timepoint [40] 0 0
Week 24
Secondary outcome [41] 0 0
Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Excluded Analyses
Timepoint [41] 0 0
Week 48
Secondary outcome [42] 0 0
Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Excluded Analyses
Timepoint [42] 0 0
Week 24
Secondary outcome [43] 0 0
Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Excluded Analyses
Timepoint [43] 0 0
Week 48
Secondary outcome [44] 0 0
Cohort 1: Change From Baseline in Plasma log10 HIV-1 RNA at Week 24
Timepoint [44] 0 0
Baseline, Week 24
Secondary outcome [45] 0 0
Cohort 1: Change From Baseline in Plasma log10 HIV-1 RNA at Week 48
Timepoint [45] 0 0
Baseline, Week 48
Secondary outcome [46] 0 0
Cohort 1: Change From Baseline in CD4+ Cell Count at Week 24
Timepoint [46] 0 0
Baseline, Week 24
Secondary outcome [47] 0 0
Cohort 1: Change From Baseline in CD4+ Cell Count at Week 48
Timepoint [47] 0 0
Baseline, Week 48
Secondary outcome [48] 0 0
Cohort 2: Change From Baseline in CD4+ Cell Count at Week 24
Timepoint [48] 0 0
Baseline, Week 24
Secondary outcome [49] 0 0
Cohort 2: Change From Baseline in CD4+ Cell Count at Week 48
Timepoint [49] 0 0
Baseline, Week 48
Secondary outcome [50] 0 0
Cohort 3: Change From Baseline in CD4+ Cell Count at Week 24
Timepoint [50] 0 0
Baseline, Week 24
Secondary outcome [51] 0 0
Cohort 3: Change From Baseline in CD4+ Cell Count at Week 48
Timepoint [51] 0 0
Baseline, Week 48
Secondary outcome [52] 0 0
Cohort 1: Change From Baseline in CD4+ Cell Percentage at Week 24
Timepoint [52] 0 0
Baseline, Week 24
Secondary outcome [53] 0 0
Cohort 1: Change From Baseline in CD4+ Cell Percentage at Week 48
Timepoint [53] 0 0
Baseline, Week 48
Secondary outcome [54] 0 0
Cohort 2: Change From Baseline in CD4+ Cell Percentage at Week 24
Timepoint [54] 0 0
Baseline, Week 24
Secondary outcome [55] 0 0
Cohort 2: Change From Baseline in CD4+ Cell Percentage at Week 48
Timepoint [55] 0 0
Baseline, Week 48
Secondary outcome [56] 0 0
Cohort 3: Change From Baseline in CD4+ Cell Percentage at Week 24
Timepoint [56] 0 0
Baseline, Week 24
Secondary outcome [57] 0 0
Cohort 3: Change From Baseline in CD4+ Cell Percentage at Week 48
Timepoint [57] 0 0
Baseline, Week 48

Eligibility
Key inclusion criteria
Key

* 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
Minimum age
2 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/05/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2025
Actual
Sample size
Target
Accrual to date
Final
129
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
District of Columbia
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Tennessee
Country [5] 0 0
United States of America
State/province [5] 0 0
Washington
Country [6] 0 0
South Africa
State/province [6] 0 0
Cape Town
Country [7] 0 0
South Africa
State/province [7] 0 0
Johannesburg
Country [8] 0 0
Thailand
State/province [8] 0 0
Bangkok
Country [9] 0 0
Thailand
State/province [9] 0 0
Chon Buri
Country [10] 0 0
Thailand
State/province [10] 0 0
Khon Kaen
Country [11] 0 0
Uganda
State/province [11] 0 0
Kampala
Country [12] 0 0
Zimbabwe
State/province [12] 0 0
Belgravia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01854775
Trial related presentations / publications
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.
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
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.
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.
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.
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.
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.
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.
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).
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).
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).
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.
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.
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.
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

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Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01854775