Recent Updates
Recently added Catalysts

EVG/COBI/FTC/TDF

Phase 2

Acquired Immunodeficiency Syndrome | Small molecule | Infectious Disease |Gilead Sciences, Inc.|Last Updated: Aug 17, 2018

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment50

FDA Designations

No designations recorded

Clinical trial landscape

EVG/COBI/FTC/TDF · 1 trial · 2 indications

Phase 2 1
NCT01721109Pharmacokinetics, Safety, and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single Tablet Regimen (STR) in AdolescentsAcquired Immunodeficiency Syndrome
COMPLETED50 Analytics
PHASE2COMPLETED
Pharmacokinetics, Safety, and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single Tablet Regimen (STR) in Adolescents
Acquired Immunodeficiency Syndrome
NCT0172110950
Unlock trial analytics

Study Endpoints

Primary Endpoints

For Part A, Pharmacokinetic (PK) Parameter: AUCtau of EVG
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)
Up to Week 48 plus 30 days

Secondary Endpoints

For Part A, PK Parameter: Ctau of EVG, FTC, Tenofovir (TFV), and COBI
Predose, 2, 4, 4.5, 5, 8, and 12 hours postdose on Day 10
For Part A, PK Parameter: Cmax of EVG, FTC, TFV, and COBI
Predose, 2, 4, 4.5, 5, 8, and 12 hours postdose on Day 10
For Part A, PK Parameter: AUCtau of FTC, TFV, and COBI
Predose, 2, 4, 4.5, 5, 8, and 12 hours postdose on Day 10
Unlock Study Endpoints

Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
EVG/COBI/FTC/TDFEXPERIMENTALParticipants 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.

Interventions

NameTypeDescription
EVG/COBI/FTC/TDFDRUG150/150/200/300 mg STR administered orally once daily with food
Unlock Study Design Details

Eligibility Criteria

Age Range12 Years to 17 Years
SexALL
Healthy VolunteersNo
Study Sites18

Key Inclusion Criteria: * 12 years to \< 18 years of age at baseline * Able to give written assent prior to any screening evaluations * Parent or guardian able to give written informed consent prior to any screening evaluations and willing to comply with study requirements * Plasma HIV-1 RNA levels...

Countries:United StatesSouth AfricaThailand
Unlock Eligibility Criteria

Frequently asked questions about EVG/COBI/FTC/TDF

What is EVG used for in HIV Infections?

EVG is an investigational small molecule being studied for the treatment of HIV Infections and Acquired Immunodeficiency Syndrome. It is developed by Gilead Sciences, Inc. and is currently in Phase 2 clinical development. EVG is intended for use in combination with other antiretroviral agents for HIV-1 infection.

What does EVG target?

EVG is an integrase inhibitor, targeting the HIV integrase enzyme. By inhibiting this enzyme, EVG is designed to block the integration of viral DNA into the host cell genome, a crucial step in the HIV replication cycle. This mechanism is being evaluated in clinical trials for the treatment of HIV-1 infection.

Who makes EVG?

EVG is developed by Gilead Sciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker GILD. Gilead is conducting clinical trials to evaluate the safety and efficacy of EVG in patients with HIV Infections and Acquired Immunodeficiency Syndrome.

What phase is EVG in?

EVG is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are ongoing to assess its safety and efficacy in treating HIV-1 infection, with completed studies involving adult and adolescent populations.

What clinical trials is EVG in?

EVG has been studied in two completed Phase 2 trials. NCT00445146 evaluated the safety of EVG with ritonavir and other antiretrovirals in 192 adults with HIV-1 infection. NCT01721109 assessed the pharmacokinetics, safety, and efficacy of an EVG-containing single tablet regimen in 50 adolescents with HIV.

Is EVG the same as elvitegravir?

Yes, EVG is the same as elvitegravir. In clinical trials, EVG is studied as part of combination regimens, such as elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate, for the treatment of HIV-1 infection. The drug is being developed by Gilead Sciences, Inc.