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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)

Impact of Menstrual Cycle on Antiretroviral Pharmacokinetics in Healthy Women

Phase 4
Completed
Conditions
Healthy
Interventions
First Posted Date
2009-03-26
Last Posted Date
2013-09-06
Lead Sponsor
University of Alabama at Birmingham
Target Recruit Count
24
Registration Number
NCT00869960
Locations
🇺🇸

University of Alabama at Birmingham, Birmingham, Alabama, United States

Rollover Study Protocol for Pediatric Patients in South Africa for Continued Access to Emtricitabine

Phase 2
Completed
Conditions
HIV-1 Infection
Interventions
First Posted Date
2008-08-28
Last Posted Date
2018-04-26
Lead Sponsor
Gilead Sciences
Target Recruit Count
50
Registration Number
NCT00743340
Locations
🇿🇦

Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital, Soweto, South Africa

🇿🇦

Themba Lethu Clinic, Helen Joseph Hospital, Westdene, Johannesburg, South Africa

An Open-Label Study of Emtricitabine in Combination With Other Antiretroviral Agents in HIV Infected Pediatric Subjects

Phase 2
Completed
Conditions
HIV Infections
Interventions
First Posted Date
2008-03-25
Last Posted Date
2008-04-10
Lead Sponsor
Gilead Sciences
Target Recruit Count
16
Registration Number
NCT00642291

Determining the Effects of Observed and Self-Administered Drug Regimens in HIV Infected Adults

Not Applicable
Completed
Conditions
HIV Infections
Interventions
Drug: Lopinavir/ritonavir
Drug: Emtricitabine/Tenofovir disoproxil fumarate
Drug: Tenofovir disoproxil fumarate
Drug: Zidovudine
Drug: Emtricitabine
First Posted Date
2008-02-06
Last Posted Date
2018-10-12
Lead Sponsor
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Target Recruit Count
529
Registration Number
NCT00608569
Locations
🇺🇬

JCRC CRS, Kampala, Uganda

🇭🇹

Les Centres GHESKIO CRS, Bicentenaire, Port-au-Prince, Haiti

🇵🇪

Barranco CRS, Lima, Peru

and more 6 locations

Characterization of Acute and Recent HIV-1 Infections in Zurich.

Not Applicable
Recruiting
Conditions
HIV Infections
Interventions
First Posted Date
2007-10-02
Last Posted Date
2024-12-17
Lead Sponsor
University of Zurich
Target Recruit Count
800
Registration Number
NCT00537966
Locations
🇨🇭

University of Zurich, Zurich, Switzerland

Efficacy of Tenofovir and Emtricitabine in ARV-naive Patients With HIV/HBV Co-infection

Phase 2
Completed
Conditions
Hepatitis B Virus
HIV Infections
Interventions
First Posted Date
2007-05-22
Last Posted Date
2016-02-22
Lead Sponsor
The HIV Netherlands Australia Thailand Research Collaboration
Target Recruit Count
24
Registration Number
NCT00476463
Locations
🇹🇭

HIV-NAT Thai Red Cross AIDS Research Center, Bangkok, Thailand

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

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

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