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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gilead Sciences
Age
2–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Cohort 1
* Age at baseline: 12 years to \< 18 years old
* Weight at screening: ≥ 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, emtricitabine (FTC) and tenofovir (TFV)
* No prior use of any approved or experimental anti-HIV-1 drug for any length of time
Cohort 2
* Age at baseline: 6 years to \< 12 years old
* Weight at screening: ≥ 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
You may not be if
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
Clareo Health | 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
