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

Emtricitabine for Naive Chinese Pregnant Chronic Hepatitis B Patients

Phase 4

Conditions: Hepatitis B, Chronic
Pregnancy

Interventions: Drug: Emtricitabine

First Posted Date: 2014-12-30

Last Posted Date: 2014-12-30

Lead Sponsor: Asian-Pacific Alliance of Liver Disease, Beijing

Target Recruit Count: 200

Registration Number: NCT02327702

Emtricitabine for Naive Child Chinese Chronic Hepatitis B Patients

Phase 4

Conditions: Hepatitis B, Chronic

Interventions: Drug: Emtricitabine

First Posted Date: 2014-12-30

Last Posted Date: 2014-12-30

Lead Sponsor: Asian-Pacific Alliance of Liver Disease, Beijing

Target Recruit Count: 200

Registration Number: NCT02327676

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

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 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

Evaluating the Safety and Tolerability of Antiretroviral Drug Regimens Used as Pre-Exposure Prophylaxis to Prevent HIV Infection in At-Risk Men Who Have Sex With Men and in At-Risk Women

Phase 2

Completed

Conditions: HIV Infection

Interventions: Drug: Maraviroc
Other: Emtricitabine placebo
Drug: Emtricitabine
Drug: Tenofovir disoproxil fumarate
Other: Tenofovir disoproxil fumarate placebo
Other: Maraviroc placebo

First Posted Date: 2012-01-06

Last Posted Date: 2021-11-05

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 594

Registration Number: NCT01505114

Locations: 🇺🇸
Weill Cornell Chelsea CRS, New York, New York, United States
🇺🇸
New Jersey Medical School Clinical Research Center CRS, Newark, New Jersey, United States
🇺🇸
UCLA CARE Center CRS, Los Angeles, California, United States

and more 10 locations

Bone, Immunologic, and Virologic Effects of a Antiretroviral Regimen

Phase 2

Completed

Conditions: HIV-1 Infection

Interventions: Drug: Darunavir
Drug: Ritonavir
Drug: Emtricitabine
Drug: Tenofovir disoproxil fumarate
Drug: Placebo for Tenofovir disoproxil fumarate
Drug: Placebo for Maraviroc
Drug: Maraviroc

First Posted Date: 2011-07-22

Last Posted Date: 2024-10-11

Lead Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Target Recruit Count: 262

Registration Number: NCT01400412

Locations: 🇺🇸
University of Colorado Hospital CRS (6101), Aurora, Colorado, United States
🇺🇸
Univ. of South Florida (USF) College of Medicine ATN CRS (33001), Tampa, Florida, United States
🇺🇸
Washington U CRS (2101), Saint Louis, Missouri, United States

and more 35 locations

The Safety, Pharmacokinetic Profile and Efficacy of Raltegravir in HIV-infected Patients at Least 60 Years of Age

Phase 4

Completed

Conditions: HIV

Interventions: Drug: Raltegravir
Drug: Tenofovir
Drug: Emtricitabine

First Posted Date: 2011-04-14

Last Posted Date: 2019-11-20

Lead Sponsor: Imperial College London

Target Recruit Count: 19

Registration Number: NCT01335620

Locations: 🇬🇧
Chelsea & Westminster Hospital NHS Trust, London, United Kingdom
🇬🇧
Imperial College Healthcare NHS Trust, London, United Kingdom

Evaluation of the Cellular Pharmacology of Tenofovir and Emtricitabine According to HIV Infection Status

Phase 1

Completed

Conditions: HIV Infections

Interventions: Drug: Emtricitabine (FTC)
Drug: Tenofovir disoproxil fumarate (TDF)
Drug: Efavirenz (EFV)
Drug: Truvada

First Posted Date: 2009-12-25

Last Posted Date: 2016-12-16

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 34

Registration Number: NCT01040091

Locations: 🇺🇸
University of Colorado CTRC CRS, Aurora, Colorado, United States

Pre-Exposure Prophylaxis in YMSM

Phase 2

Completed

Conditions: HIV

Interventions: Drug: coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP
Drug: Placebo
Behavioral: Many Men, Many Voices (3MV)

First Posted Date: 2009-12-17

Last Posted Date: 2017-04-17

Lead Sponsor: University of North Carolina, Chapel Hill

Target Recruit Count: 68

Registration Number: NCT01033942

Locations: 🇺🇸
Childrens Memorial Hospital, Chicago, Illinois, United States
🇺🇸
Ruth M Rothstein CORE Center/ John H Stroger Jr Hospital, Chicago, Illinois, United States

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