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Emtricitabine

Generic Name
Emtricitabine
Brand Names
Atripla, Biktarvy, Complera, Descovy, Emtriva, Genvoya, Odefsey, Stribild, Truvada
Drug Type
Small Molecule
Chemical Formula
C8H10FN3O3S
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)

Open-Label, 48-Week Extension Study of Elvucitabine in Combination With Background Antiretroviral Therapy (ART) for Participants Who Have Completed Study ACH443-014A

Phase 2
Completed
Conditions
Human Immunodeficiency Virus (HIV)-1 Infection
First Posted Date
2006-09-25
Last Posted Date
2023-08-14
Lead Sponsor
Alexion Pharmaceuticals, Inc.
Target Recruit Count
4
Registration Number
NCT00380159
Locations
🇪🇸

Clinical Trial Site, Madrid, Spain

Backup With Combivir or Single Dose (SD) Truvada in Order to Avoid Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) Resistance After SD Nevirapine for the Prevention of Mother-to-child Transmission (PMTCT)

Not Applicable
Completed
Conditions
HIV Infections
Interventions
First Posted Date
2006-06-30
Last Posted Date
2016-02-23
Lead Sponsor
Rigshospitalet, Denmark
Target Recruit Count
566
Registration Number
NCT00346567
Locations
🇹🇿

Bombo Regional Hospital, Tanga, Tanzania

Tenofovir/Emtricitabine for PMTCT in Africa and Asia (ANRS 12109 TEmAA)

Phase 2
Completed
Conditions
HIV Infection
Pregnancy
First Posted Date
2006-06-07
Last Posted Date
2011-12-05
Lead Sponsor
French National Agency for Research on AIDS and Viral Hepatitis
Target Recruit Count
72
Registration Number
NCT00334256
Locations
🇨🇮

Centre de Prise en Charge et de Formation ACONDA, Abidjan, Côte D'Ivoire

🇰🇭

Calmette Hospital, Phnom Penh, Cambodia

🇿🇦

PHRU, Soweto, South Africa

SWEET: Once Daily Truvada Versus Twice Daily Combivir for the Treatment of HIV Infection

Phase 3
Completed
Conditions
HIV Infections
First Posted Date
2006-05-09
Last Posted Date
2008-07-04
Lead Sponsor
Gilead Sciences
Target Recruit Count
220
Registration Number
NCT00323544
Locations
🇬🇧

Gilead Sciences, Cambridge, United Kingdom

Treatment of Persistent Viremia (Virus in Blood) in Chronic Hepatitis B Subjects Already Receiving Adefovir Dipivoxil

Phase 2
Completed
Conditions
Chronic Hepatitis B
Interventions
First Posted Date
2006-03-28
Last Posted Date
2011-11-01
Lead Sponsor
Gilead Sciences
Target Recruit Count
106
Registration Number
NCT00307489

A Randomised, Open-label Trial to Assess the Safety and Efficacy of Switching to Tenofovir-emtricitabine or Abacavir-lamivudine: The STEAL Study

First Posted Date
2005-09-19
Last Posted Date
2011-05-25
Lead Sponsor
Kirby Institute
Target Recruit Count
357
Registration Number
NCT00192634
Locations
🇦🇺

QLD Health - AIDS Medical Unit, Brisbane, Queensland, Australia

🇦🇺

John Hunter Hospital, Newcastle, New South Wales, Australia

🇦🇺

The Centre Clinic, Melbourne, Victoria, Australia

and more 28 locations

Simple Once Daily Triple Regimen Including Tenofovir, Emtricitabine and Efavirenz in HIV-1 Infected Patients (ANRS 1207)

Phase 3
Completed
Conditions
HIV Infection
First Posted Date
2005-09-12
Last Posted Date
2007-07-03
Lead Sponsor
French National Agency for Research on AIDS and Viral Hepatitis
Target Recruit Count
40
Registration Number
NCT00158457
Locations
🇸🇳

Centre de Traitement Ambulatoire, CHU de Fann, Dakar, Senegal

🇸🇳

Service des Maladies Infectieuses, CHU de Fann, Dakar, Senegal

Virological and Clinical Anti-Hepatitis B Virus (HBV) Efficacy of Tenofovir and Emtricitabine in Patients With HIV/HBV co-Infection

Phase 4
Completed
Conditions
HIV Infections
Hepatitis B
First Posted Date
2005-08-09
Last Posted Date
2007-04-24
Lead Sponsor
International Antiviral Therapy Evaluation Center
Target Recruit Count
24
Registration Number
NCT00127959
Locations
🇳🇱

Academic Medical Center, Amsterdam, NH, Netherlands

Efficacy of Tenofovir-Emtricitabine and Efavirenz in HIV Infected Patients With Tuberculosis (ANRS129)

Phase 3
Completed
Conditions
HIV Infections
Tuberculosis
First Posted Date
2005-06-24
Last Posted Date
2011-12-22
Lead Sponsor
French National Agency for Research on AIDS and Viral Hepatitis
Target Recruit Count
70
Registration Number
NCT00115609
Locations
🇫🇷

Service des maladies Infectieuses et tropicales Hopital Necker-Enfants Malades, Paris, France

Tenofovir Disoproxil Fumarate/Emtricitabine/Efavirenz Versus Combivir/Efavirenz in Antiretroviral-Naive HIV-1 Infected Subjects

Phase 3
Completed
Conditions
HIV Infections
Interventions
First Posted Date
2005-05-30
Last Posted Date
2010-10-13
Lead Sponsor
Gilead Sciences
Target Recruit Count
517
Registration Number
NCT00112047
Locations
🇺🇸

Orlando Immunology Center, Orlando, Florida, United States

🇺🇸

AIDS Healthcare Foundation Research, Beverly Hills, California, United States

🇺🇸

Capital Medical Associates, P.C., Washington, District of Columbia, United States

and more 2 locations
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