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

A Study to Evaluate the Efficacy, Safety, and Tolerability of Using an Oral Once-daily 2 Drug Regimen Compared to an Oral Once-daily 3 Drug Regimen for the Treatment of Human Immunodeficiency Virus (HIV)-1 in Adults Who Have Not Previously Taken Antiretroviral Therapy

Phase 3

Recruiting

Conditions: HIV
HIV Infections

Interventions: Drug: Dolutegravir
Drug: Bictegravir
Drug: Lamivudine
Drug: Emtricitabine
Drug: Tenofovir alafenamide

First Posted Date: 2023-08-07

Last Posted Date: 2024-08-19

Lead Sponsor: ViiV Healthcare

Target Recruit Count: 412

Registration Number: NCT05979311

Locations: 🇬🇧
GSK Investigational Site, London, United Kingdom

Pharmacokinetics of Antiretroviral Drugs in Lactating Women and Breastmilk Fed Infants Under 6 Months of Age in Botswana

Recruiting

Conditions: Lactating Women on Select DOI
Breastmilk Fed Infants of Mothers on Select DOI
HIV Infections

Interventions: Drug: Dolutegravir
Drug: Lamivudine
Drug: Emtricitabine
Drug: Tenofovir Disoproxil Fumarate

First Posted Date: 2021-04-28

Last Posted Date: 2024-02-29

Lead Sponsor: Duke University

Target Recruit Count: 200

Registration Number: NCT04862975

Locations: 🇿🇦
Botswana-UPenn Partnership, Botswana, Gaborone, South Africa
🇿🇦
Old Naledi Clinic, Botswana, Gaborone, South Africa
🇿🇦
Mogoditshane Clinic KDC, Botswana, Gaborone, South Africa

and more 1 locations

Evaluation of Drug Interaction Between HS-10234 and Emtriccitabine

Phase 1

Completed

Conditions: Healthy Subjects

Interventions: Drug: HS-10234
Drug: Emtricitabine

First Posted Date: 2020-07-20

Last Posted Date: 2020-10-01

Lead Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

Target Recruit Count: 36

Registration Number: NCT04477096

Locations: 🇨🇳
Xiangya Hospital, Central South University, Changsha, Hunan, China

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

Phase 1

Completed

Conditions: HIV/AIDS

Interventions: Drug: Tenofovir 300Mg Oral Tablet
Drug: Emtricitabine 200 MG

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

Role of Exogenous and Endogenous Sex Hormones on Tenofovir and Emtricitabine Disposition in Female Genital Tract

Completed

Conditions: Menopause
HIV/AIDS
Inflammation Vagina

First Posted Date: 2017-07-14

Last Posted Date: 2024-04-16

Lead Sponsor: University of Minnesota

Target Recruit Count: 28

Registration Number: NCT03218085

Locations: 🇺🇸
University of Minnesota, Minneapolis, Minnesota, United States

The Cellular Pharmacology of F-TAF in Dried Blood Spots

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: emtricitabine 200 mg/tenofovir alafenamide 25mg

First Posted Date: 2016-11-11

Last Posted Date: 2021-01-25

Lead Sponsor: University of Colorado, Denver

Target Recruit Count: 38

Registration Number: NCT02962739

Locations: 🇺🇸
University of Colorado- Anschutz Campus, Aurora, Colorado, United States

PK and PD Study of Oral F/TAF for HIV Prevention

Phase 1

Completed

Conditions: HIV

Interventions: Drug: Emtricitabine
Drug: Tenofovir alafenamide
Drug: Tenofovir disoproxil

First Posted Date: 2016-09-19

Last Posted Date: 2018-02-19

Lead Sponsor: CONRAD

Target Recruit Count: 73

Registration Number: NCT02904369

Locations: 🇺🇸
Eastern Virginia Medical School Clinical Research Center, Norfolk, Virginia, United States
🇺🇸
Magee-Womens Research Institute and Foundation, Pittsburgh, Pennsylvania, United States
🇩🇴
Profamilia, Santo Domingo, Dominican Republic