Emtricitabine

Generic Name: Emtricitabine

Brand Names: Atripla, Biktarvy, Complera, Descovy, Emtriva, Genvoya, Odefsey, Stribild, Truvada

Drug Type: Small Molecule

Chemical Formula: C_₈H_₁₀FN_₃O_₃S

CAS Number: 143491-57-0

Unique Ingredient Identifier: G70B4ETF4S

Background: Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI) indicated for the treatment of HIV infection in adults or combined with tenofovir alafenamide for the prevention of HIV-1 infection in high risk adolescents and adults. Emtricitabine is a cytidine analogue. The drug works by inhibiting HIV reverse transcriptase, preventing transcription of HIV RNA to DNA.

Emtricitabine was granted FDA approval on 2 July 2003.

Indication: Emtricitabine is indicated in combination with other medications for the treatment of HIV-1 infections; treatment of HIV-1 infections in pediatric patients 25-35kg, treatment of HIV-1 infections in adult patients ≥35kg, for pre exposure prophylaxis of HIV-1 in adolescent and adult patients excluding those who have receptive vaginal sex; treatment of HIV-1 infections in pediatric and adult patients ≥17kg, pre exposure prophylaxis in adolescents and adults ≥35kg; treatment of HIV-1 in patients ≥12 years and ≥35kg; treatment of HIV-1 in patients weighing ≥35kg; treatment of HIV-1 in patients weighing ≥25kg; and treatment of HIV-1 in patients weighing ≥40kg.

Associated Conditions: HIV Transmission, Human Immunodeficiency Virus (HIV) Infections, Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Associated Therapies: Pre-Exposure Prophylaxis (PrEP)

Clinical Trials

PK and PD Study of Oral F/TAF for HIV Prevention

Phase 1

Completed

Conditions: HIV

Interventions: Drug: Emtricitabine
Drug: Tenofovir alafenamide
Drug: Tenofovir disoproxil

First Posted Date: 2016-09-19

Last Posted Date: 2018-02-19

Lead Sponsor: CONRAD

Target Recruit Count: 73

Registration Number: NCT02904369

Locations: 🇺🇸
Eastern Virginia Medical School Clinical Research Center, Norfolk, Virginia, United States
🇺🇸
Magee-Womens Research Institute and Foundation, Pittsburgh, Pennsylvania, United States
🇩🇴
Profamilia, Santo Domingo, Dominican Republic

Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex With Men and Are At Risk of HIV-1 Infection

Phase 3

Active, not recruiting

Conditions: Pre-Exposure Prophylaxis of HIV-1 Infection

Interventions: Drug: F/TAF
Drug: F/TDF
Drug: F/TAF Placebo
Drug: F/TDF Placebo

First Posted Date: 2016-07-22

Last Posted Date: 2024-10-22

Lead Sponsor: Gilead Sciences

Target Recruit Count: 5399

Registration Number: NCT02842086

Switching From a Tenofovir Disoproxil Fumarate (TDF) Containing Regimen to Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Alafenamide (E/C/F/TAF) Fixed-Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Infected Adults Aged ≥ 60 Years

Phase 3

Completed

Conditions: HIV-1 Infection

Interventions: Drug: TDF
Drug: E/C/F/TAF
Drug: FTC
Drug: FTC/TDF
Drug: 3TC
Drug: Third agent

First Posted Date: 2015-11-30

Last Posted Date: 2020-03-04

Lead Sponsor: Gilead Sciences

Target Recruit Count: 167

Registration Number: NCT02616783

Locations: 🇫🇷
Hopital Necker les Enfants Malades, Paris, France
🇧🇪
University Hospital Gent, Ghent, Belgium
🇮🇹
Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy

and more 32 locations

SSAT058: Atripla to Eviplera Switch in Patients Without Central Nervous System Symptoms

Phase 4

Completed

Conditions: HIV

Interventions: Drug: Eviplera

First Posted Date: 2015-08-19

Last Posted Date: 2017-09-18

Lead Sponsor: St Stephens Aids Trust

Target Recruit Count: 40

Registration Number: NCT02529059

Locations: 🇬🇧
St. Mary's Hospital, London, United Kingdom
🇬🇧
St. Stephen's Centre, London, United Kingdom
🇬🇧
Brighton & Sussex University Hospitals Nhs Trust, Brighton, United Kingdom