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



Status:Recruiting
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:2 - Any
Updated:3/10/2019
Start Date:May 6, 2013
End Date:July 2020
Contact:Gilead Study Team
Email:GS-US-292-0106@gilead.com

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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

There will be 3 cohorts in this study.

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) single tablet regimen
(STR) (Part A) and to evaluate the safety and tolerability of E/C/F/TAF STR through Week 24
(Part B) in 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.


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 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.
We found this trial at
5
sites
262 Danny Thomas Pl
Memphis, Tennessee 38105
(901) 495-3300
Principal Investigator: Aditya Gaur, MD
Phone: 901-495-5067
St. Jude Children's Research Hospital St. Jude is unlike any other pediatric treatment and research...
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1648 Pierce Dr NE
Atlanta, Georgia 30322
(404) 727-5640
Emory University School of Medicine Emory University School of Medicine has 2,359 full- and part-time...
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Long Beach, California 90806
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Washington, District of Columbia 20010
Principal Investigator: Natella Rakhmanina, MD
Phone: 202-476-2083
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