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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)

Defining the PrEP Care Continuum Among Recently Incarcerated Men at High-Risk for HIV Infection

Phase 4
Conditions
HIV Infections
Sexually Transmitted Diseases
First Posted Date
2020-01-27
Last Posted Date
2021-02-23
Lead Sponsor
The Miriam Hospital
Target Recruit Count
100
Registration Number
NCT04240509
Locations
🇺🇸

The Miriam Hospital, Providence, Rhode Island, United States

A Study in Healthy Participants to Assess the Effect of Darunavir, Emtricitabine, and Tenofovir Alafenamide in the Presence of Cobicistat When Administered as a Fixed Dose Combination (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide) Compared to the Co-administration of the Separate Agents

Phase 1
Terminated
Conditions
Healthy
Interventions
Drug: Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC
First Posted Date
2020-01-22
Last Posted Date
2020-07-07
Lead Sponsor
Janssen Pharmaceutica N.V., Belgium
Target Recruit Count
16
Registration Number
NCT04236453
Locations
🇳🇱

PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini, Groningen, Netherlands

Study of Doravirine/Islatravir (DOR/ISL 100 mg/0.75 mg) to Evaluate the Antiretroviral Activity, Safety, and Tolerability in Treatment-Naïve Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-020)

Phase 3
Completed
Conditions
HIV-1 Infection
Interventions
Drug: DOR/ISL
Drug: Placebo to BIC/FTC/TAF
Drug: Placebo to DOR/ISL
First Posted Date
2020-01-18
Last Posted Date
2025-02-24
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
599
Registration Number
NCT04233879
Locations
🇺🇸

Ruane Clinical Research Group, Inc. ( Site 5624), Los Angeles, California, United States

🇺🇸

The Kinder Medical Group ( Site 5615), Miami, Florida, United States

🇺🇸

University of Pennsylvania ( Site 5630), Philadelphia, Pennsylvania, United States

and more 92 locations

Switch to Doravirine/Islatravir (DOR/ISL) in Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-018)

Phase 3
Completed
Conditions
HIV Infection
Interventions
Drug: DOR/ISL
Drug: Placebo to BIC/FTC/TAF
Drug: Placebo to FDC DOR/ISL
First Posted Date
2020-01-10
Last Posted Date
2025-03-30
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
643
Registration Number
NCT04223791
Locations
🇫🇷

Hopital Edouard Herriot ( Site 3126), Lyon, Ain, France

🇫🇷

CHU de Nice Hopital Archet 1 ( Site 3103), Nice, Alpes-Maritimes, France

🇮🇹

A.O.R.N. dei Colli - Ospedale Cotugno ( Site 3507), Napoli, Italy

and more 86 locations

Study of Truvada for HIV Pre Exposure Prophylaxis Using Daily Directly Observed Therapy to Look at Potential Interactions Between Truvada and Hormone Therapy

Phase 4
Completed
Conditions
HIV Prevention
Transgender Health
Interventions
First Posted Date
2019-08-08
Last Posted Date
2021-05-11
Lead Sponsor
University of California, San Francisco
Target Recruit Count
48
Registration Number
NCT04050371
Locations
🇺🇸

San Francisco AIDS foundation, San Francisco, California, United States

Combination Antiretroviral Therapy (cART) for PBC

Phase 2
Completed
Conditions
Primary Biliary Cholangitis
Interventions
First Posted Date
2019-05-17
Last Posted Date
2024-02-16
Lead Sponsor
University of Alberta
Target Recruit Count
37
Registration Number
NCT03954327
Locations
🇨🇦

University of Alberta, Edmonton, Alberta, Canada

🇨🇦

University of Toronto, Toronto, Ontario, Canada

🇨🇦

University of Montreal, Montréal, Quebec, Canada

and more 3 locations

Quantification of Estradiol's Impact on Nucleotides in Cellular Populations of the Lower GI Tract

Phase 1
Completed
Conditions
HIV/AIDS
Interventions
First Posted Date
2019-04-17
Last Posted Date
2023-04-12
Lead Sponsor
University of North Carolina, Chapel Hill
Target Recruit Count
10
Registration Number
NCT03917420
Locations
🇺🇸

University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States

DOT Diary Mobile App for Pre-Exposure Prophylaxis Adherence in Young Men

Phase 4
Completed
Conditions
Adherence, Medication
Risk Behavior
Pre-Exposure Prophylaxis
HIV Prevention
Interventions
First Posted Date
2018-12-11
Last Posted Date
2021-04-09
Lead Sponsor
Public Health Foundation Enterprises, Inc.
Target Recruit Count
100
Registration Number
NCT03771638
Locations
🇺🇸

Bridge HIV, San Francisco Department of Public Health, San Francisco, California, United States

🇺🇸

Emory University, School of Public Health, Atlanta, Georgia, United States

Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naive, HIV-1 and Hepatitis B Co-Infected Adults

Phase 3
Completed
Conditions
HIV-1/HBV Co-Infection
Interventions
Drug: B/F/TAF
Drug: Placebo to match DTG
Drug: Placebo to match F/TDF
Drug: Placebo to match B/F/TAF
First Posted Date
2018-06-06
Last Posted Date
2025-03-19
Lead Sponsor
Gilead Sciences
Target Recruit Count
244
Registration Number
NCT03547908
Locations
🇪🇸

Hospital General Universitario de Valencia, Valencia, Spain

🇨🇳

Taipei Veterans General Hospital, Taipei City, Taiwan

🇪🇸

CHUVI - Hospital Universitario Alvaro Cunqueiro, Vigo, Spain

and more 66 locations

RESIST-2: 2nd-line ART for HIV-2 Infection

First Posted Date
2018-01-09
Last Posted Date
2021-01-25
Lead Sponsor
University of Washington
Target Recruit Count
152
Registration Number
NCT03394196
Locations
🇸🇳

Clinique des Maladies Infectieuses Ibrahima DIOP Mar/CRCF, Centre Hospitalier Universitaire de Fann, Dakar, Senegal

🇸🇳

Centre de Sante de Ziguinchor, Ziguinchor, Casamance, Senegal

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