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More info
You can access this
clinical trial
if you have
Acquired Immunodeficiency Syndrome or HIV Infections
and you are
between 12 and 17
years old
2
3
This is an advanced phase trial assessing
the effectiveness of the new treatment before being released on the market.
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The purpose

This study is to evaluate the steady-state pharmacokinetics (PK) and confirm the dose of the elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF) single tablet regimen (STR) in HIV-1 infected, antiretroviral (ARV) treatment-naive adolescents. Safety, tolerability, and efficacy will also be evaluated through Week 48. A total of 50 adolescent participants (12 to < 18 years of age) will be enrolled to receive EVG/COBI/FTC/TDF as follows: - Part A: Twelve to 16 eligible participants will be enrolled to evaluate steady-state PK, and confirm the dose, with the intent to enroll at least 4 participants 12 to < 15 and at least 4 participants 15 to < 18 years of age. - Part B: Following confirmation of EVG exposure in at least 12 participants from Part A, 34 to 38 participants in addition to those enrolled in Part A will be enrolled to evaluate the safety, tolerability and antiviral activity of EVG/COBI/FTC/TDF STR.

Provided treatments

  • Drug: EVG/COBI/FTC/TDF

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01721109. The sponsor of the trial is Gilead Sciences and it is looking for 50 volunteers for the current phase.
Official trial title:
A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/ Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents