Efficacy and Safety of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Adolescents

HIV Clinical Trial

Official title:

A Phase 2/3, Open-Label Study to Evaluate the Safety and Efficacy of E/C/F/TAF in HIV-1 Infected Virologically Suppressed Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02276612
• Other study ID #: GS-US-292-1515
• Secondary ID: 2014-002673-11
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: December 3, 2014
• Est. completion date: October 23, 2017

Study information

• Verified date: January 2018
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to evaluate the safety and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) in HIV-infected virologically suppressed adolescents 12 to < 18 years of age.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 23, 2017
• Est. primary completion date: November 10, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

Key Inclusion Criteria:

• Currently on a stable antiretroviral regimen for = 6 consecutive months

• Weight = 35 kg (77 lbs.)

• Plasma HIV-1 RNA levels < 50 copies/mL for = 6 months

• CD4+ cell count > 100 cells/µL

• No resistance to elvitegravir (EVG), emtricitabine (FTC), lamivudine (3TC) or tenofovir (TFV)

• Hepatic transaminases (AST and ALT) = 5 x upper limit of normal (ULN)

• No evidence of current hepatitis B virus (HBV) infection

• No evidence of current hepatitis C virus (HCV) infection

Note: participants from Gilead Study GS-US-162-0112 were allowed to roll over into this Study GS-US-292-1515 even if they were 18 years or older at the time of screening.

Key Exclusion Criteria:

• A new AIDS-defining condition diagnosed within the 30 days prior to Screening

• Evidence of active pulmonary or extra-pulmonary tuberculosis disease within 3 months of screening

• Pregnant or lactating subjects

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Related Conditions & MeSH terms

• HIV

Intervention

Drug:
• E/C/F/TAF
150/150/200/10 mg fixed-dose combination (FDC) tablet administered orally once daily with food

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Serious Adverse Events	The percentage of participants experiencing any treatment-emergent serious adverse event was summarized.	Up to Week 48
Primary	Incidence of Treatment-Emergent Adverse Events	The percentage of participants experiencing any treatment-emergent adverse event was summarized.	Up to Week 48
Secondary	Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL at Week 24 (FDA-defined Snapshot Analysis)	The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.	Week 24
Secondary	Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL at Week 48 (FDA-defined Snapshot Analysis)	The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.	Week 48
Secondary	Change From Baseline in CD4 Cell Count at Week 24		Baseline; Week 24
Secondary	Change From Baseline in CD4 Cell Count at Week 48		Baseline; Week 48
Secondary	Change From Baseline in CD4 Percentage at Week 24		Baseline; Week 24
Secondary	Change From Baseline in CD4 Percentage at Week 48		Baseline; Week 48