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

Effect of SwitChing AtriPla to Eviplera on Neurocognitive and Emotional Functioning

Phase 4

Completed

Conditions: HIV Associated Neurocognitive Disorder
Neurocognitive Decline

Interventions: Drug: Eviplera

First Posted Date: 2014-12-04

Last Posted Date: 2017-10-27

Lead Sponsor: UMC Utrecht

Target Recruit Count: 58

Registration Number: NCT02308332

Locations: 🇳🇱
UMC Utrecht, Utrecht, Netherlands

Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284)

Phase 2

Terminated

Conditions: HIV Infections

Interventions: Drug: Raltegravir (MK-0518)
Drug: Tenofovir
Drug: Nevirapine
Drug: Emtricitabine
Drug: Lamivudine
Drug: Lopinavir
Drug: Ritonavir
Drug: Atazanavir
Drug: Darunavir

First Posted Date: 2014-04-17

Last Posted Date: 2019-04-08

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 11

Registration Number: NCT02116660

Implementation of the Pre-Exposure Prophylaxis (PrEP) to HIV: A Demonstrative Project.

Not Applicable

Conditions: HIV

Interventions: Drug: emtricitabine / tenofovir 200/300 mg

First Posted Date: 2013-11-21

Last Posted Date: 2015-10-12

Lead Sponsor: Oswaldo Cruz Foundation

Target Recruit Count: 400

Registration Number: NCT01989611

Locations: 🇧🇷
Centro de Referência e Treinamento DST/AIDS, Sao Paulo, SP, Brazil
🇧🇷
University of Sao Paulo - Hospital das Clínicas da Faculdade de Medicina da USP, Sao Paulo, SP, Brazil
🇧🇷
Instituto de Pesquisa Clínica Evandro Chagas - IPEC / FIOCRUZ, Rio de Janeiro, RJ, Brazil

HIV Non-Occupational Post-Exposure Prophylaxis

Phase 4

Completed

Conditions: Human Immunodeficiency Virus

Interventions: Drug: Single Dose Elivitegravir (150mg), Combicistat (150mg), Emtricitabine (200mg), Tenofovir DF (300mg)

First Posted Date: 2013-05-17

Last Posted Date: 2022-04-19

Lead Sponsor: Kenneth H. Mayer, MD

Target Recruit Count: 100

Registration Number: NCT01855867

Locations: 🇺🇸
Fenway Community Health, Boston, Massachusetts, United States

Study to Evaluate a HIV Drug for the Treatment of HIV Infection

Phase 2

Completed

Conditions: Infection, Human Immunodeficiency Virus
HIV Infections

Interventions: Drug: Atazanavir
Drug: BMS-955176
Drug: Placebo matching with BMS-955176
Drug: Tenofovir
Drug: Ritonavir
Drug: Emtricitabine

First Posted Date: 2013-03-04

Last Posted Date: 2019-11-25

Lead Sponsor: ViiV Healthcare

Target Recruit Count: 107

Registration Number: NCT01803074

Locations: 🇩🇪
GSK Investigational Site, Berlin, Germany

A Demonstration Project to Add Pre- or Post-exposure Prophylaxis to Combination HIV Prevention Services

Phase 4

Completed

Conditions: HIV Prevention

Interventions: Drug: emtricitabine 200mg/tenofovir 300mg

First Posted Date: 2013-02-01

Last Posted Date: 2018-04-06

Lead Sponsor: University of California, Los Angeles

Target Recruit Count: 328

Registration Number: NCT01781806

Locations: 🇺🇸
L.A. Gay and Lesbian Center, Los Angeles, California, United States
🇺🇸
The OASIS Clinic, Los Angeles, California, United States

A Clinical Trial Comparing the Efficacy of Tenofovir Disoproxil Fumarate/Emtricitabine/Rilpivirine (TDF/FTC/RPV) Versus TDF/FTC/Efavirenz (TDF/FTC/EFV) in Patients With Undetectable Plasma HIV-1 RNA on Current First-line Treatment

Phase 3

Completed

Conditions: Human Immunodeficiency Virus-type 1 Infection

Interventions: Drug: Rilpivirine
Drug: Efavirenz
Drug: Tenofovir disoproxil fumarate
Drug: Emtricitabine

First Posted Date: 2012-10-17

Last Posted Date: 2021-02-11

Lead Sponsor: Janssen-Cilag International NV

Target Recruit Count: 426

Registration Number: NCT01709084

Safety, Pharmacokinetics, Pharmacodynamics, and Disintegration Time of Vaginal Tablets Containing Tenofovir and/or Emtricitabine

Phase 1

Completed

Conditions: HIV

Interventions: Drug: Emtricitabine (FTC) Alone Vaginal Tablet
Drug: TFV and FTC Combined Vaginal Tablet
Drug: Placebo Vaginal Tablet
Drug: Tenofovir (TFV) Alone Vaginal Tablet

First Posted Date: 2012-09-27

Last Posted Date: 2015-04-03

Lead Sponsor: CONRAD

Target Recruit Count: 48

Registration Number: NCT01694407

Locations: 🇺🇸
Albert Einstein College of Medicine, Bronx, New York, United States
🇺🇸
Clinical Research Center, Eastern Virginia Medical School, Norfolk, Virginia, United States