Pharmacokinetics, Safety, and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single Tablet Regimen (STR) in Adolescents
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|ClinicalTrials.gov Identifier: NCT01721109|
Recruitment Status : Completed
First Posted : November 4, 2012
Results First Posted : April 10, 2017
Last Update Posted : August 17, 2018
The primary objectives of this study are 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) (Part A) and to evaluate the safety and tolerability of EVG/COBI/FTC/TDF STR through Week 48 (Part B) in HIV-1 infected, antiretroviral (ARV) treatment-naive adolescents.
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.
|Condition or disease||Intervention/treatment||Phase|
|Acquired Immunodeficiency Syndrome HIV Infections||Drug: EVG/COBI/FTC/TDF||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official 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|
|Actual Study Start Date :||December 6, 2012|
|Actual Primary Completion Date :||October 22, 2015|
|Actual Study Completion Date :||January 29, 2018|
Participants will receive treatment for 48 weeks and then had the option to enter an Extension Phase to receive EVG/COBI/FTC/TDF until 1) the age of 18, 2) EVG/COBI/FTC/TDF becomes commercially available in the country the participant is enrolled, or 3) Gilead elects to terminate the development of EVG/COBI/FTC/TDF in that country.
150/150/200/300 mg STR administered orally once daily with food
Other Name: Stribild®
- For Part A, Pharmacokinetic (PK) Parameter: AUCtau of EVG [ Time Frame: Predose, 2, 4, 4.5, 5, 8, and 12 hours postdose on Day 10 ]AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
- Incidence of Treatment-Emergent Serious Adverse Events (SAEs) and All Treatment-Emergent Adverse Events (AEs) [ Time Frame: Up to Week 48 plus 30 days ]
- For Part A, PK Parameter: Ctau of EVG, FTC, Tenofovir (TFV), and COBI [ Time Frame: Predose, 2, 4, 4.5, 5, 8, and 12 hours postdose on Day 10 ]Ctau is defined as the observed drug concentration at the end of the dosing interval.
- For Part A, PK Parameter: Cmax of EVG, FTC, TFV, and COBI [ Time Frame: Predose, 2, 4, 4.5, 5, 8, and 12 hours postdose on Day 10 ]Cmax is defined as the maximum concentration of drug.
- For Part A, PK Parameter: AUCtau of FTC, TFV, and COBI [ Time Frame: Predose, 2, 4, 4.5, 5, 8, and 12 hours postdose on Day 10 ]AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 24 and 48 as Defined by the FDA Snapshot Analysis [ Time Frame: Weeks 24 and 48 ]
- Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Weeks 24 and 48 as Defined by the FDA Snapshot Analysis [ Time Frame: Weeks 24 and 48 ]
- Change From Baseline in Plasma log10 HIV-1 RNA at Weeks 24 and 48 [ Time Frame: Baseline; Weeks 24 and 48 ]
- Change From Baseline in CD4+ Cell Count at Weeks 24 and 48 [ Time Frame: Baseline; Weeks 24 and 48 ]
- Change From Baseline in CD4 Percentage at Weeks 24 and 48 [ Time Frame: Baseline; Weeks 24 and 48 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01721109
|Study Director:||Gilead Study Director||Gilead Sciences|