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

DOT Diary Optimization Pilot: A Pilot Study to Optimize the DOT Diary App to Measure PrEP Adherence

Phase 4

Completed

Conditions: Adherence, Medication
Risk Behavior
Pre-Exposure Prophylaxis
HIV Prevention

Interventions: Drug: Emtricitabine / Tenofovir Disoproxil Oral Tablet
Other: DOT Diary mobile app

First Posted Date: 2018-01-02

Last Posted Date: 2021-10-27

Lead Sponsor: Public Health Foundation Enterprises, Inc.

Target Recruit Count: 20

Registration Number: NCT03387462

Locations: 🇺🇸
Bridge HIV, San Francisco Department of Public Health, San Francisco, California, United States
🇺🇸
Emory University, School of Public Health, Atlanta, Georgia, United States

Clinical Trial to Evaluate the Efficacy, Pharmacokinetics (PK) Interactions and Safety of Dolutegravir Plus 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs) in HIV-1-Infected Solid Organ Transplant Patients

Phase 4

Conditions: HIV-1-infection
Solid Organ Transplant

Interventions: Drug: Lamivudine 300 MG
Drug: Abacavir 600 MG
Drug: Tenofovir Disoproxil 245Mg Tablet
Drug: Emtricitabine 200 MG
Drug: Dolutegravir 50 mg

First Posted Date: 2017-12-04

Last Posted Date: 2020-02-05

Lead Sponsor: Fundacion Clinic per a la Recerca Biomédica

Target Recruit Count: 20

Registration Number: NCT03360682

Locations: 🇪🇸
Hospital Clínico y provincial de Barcelona, Barcelona, Spain

Bioequivalence Study of Two Formulatiosns With the Asscociaton of Efavirenz, Emtricitabine and Tenofovir

Phase 4

Completed

Conditions: Healthy

Interventions: Drug: Efavirenz, tenofovir disoproxil fumarate and emtricitabine

First Posted Date: 2017-10-13

Last Posted Date: 2017-10-13

Lead Sponsor: Laboratorio Elea Phoenix S.A.

Target Recruit Count: 24

Registration Number: NCT03309566

Locations: 🇦🇷
DominguezLab, Paraná, Entre Ríos, Argentina

Implementation of PrEP to HIV in Brazilian Transgender Women

Phase 4

Conditions: HIV, Prevention

Interventions: Drug: emtricitabine / tenofovir 200/300 mg

First Posted Date: 2017-07-18

Last Posted Date: 2018-07-31

Lead Sponsor: Oswaldo Cruz Foundation

Target Recruit Count: 120

Registration Number: NCT03220152

Locations: 🇧🇷
Instituto Nacional de Infectologia Evandro Chagas (INI) - Fiocruz, Rio de Janeiro, Brazil

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

Evaluating the Feasibility and Acceptability of Implementing a PrEP Program in PR-CoNCRA (San Juan, Puerto Rico)- Part B

Phase 4

Conditions: HIV/AIDS

Interventions: Drug: Emtricitabine and Tenofovir

First Posted Date: 2017-04-19

Last Posted Date: 2018-04-05

Lead Sponsor: Puerto Rico Community Network for Clinical Research on AIDS

Target Recruit Count: 75

Registration Number: NCT03120494

Locations: 🇵🇷
Puerto Rico Community Network for Clinical Research on AIDS (PR-CoNCRA), San Juan, Puerto Rico

The Stay Study: A Demonstration Project Advancing PrEP Delivery in the San Francisco Bay Area Transgender Community

Phase 4

Completed

Conditions: Pre-Exposure Prophylaxis
Transgender Persons

Interventions: Drug: Emtricitabine / Tenofovir Disoproxil Oral Tablet
Behavioral: PrEP support

First Posted Date: 2017-04-19

Last Posted Date: 2021-04-21

Lead Sponsor: Public Health Foundation Enterprises, Inc.

Target Recruit Count: 158

Registration Number: NCT03120936

Locations: 🇺🇸
Tri-City Health Center, Fremont, California, United States
🇺🇸
Bridge HIV, San Francisco Department of Public Health, San Francisco, California, United States
🇺🇸
Tom Waddell Urban Health Clinic, San Francisco, California, United States

and more 2 locations

Evaluating the Efficacy and Safety of Dolutegravir-Containing Versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and Their Infants

Phase 3

Completed

Conditions: HIV Infections

Interventions: Drug: Dolutegravir
Drug: Efavirenz/emtricitabine/tenofovir disoproxil fumarate
Drug: Emtricitabine/tenofovir alafenamide
Drug: Emtricitabine/tenofovir disoproxil fumarate

First Posted Date: 2017-02-09

Last Posted Date: 2022-11-21

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

Target Recruit Count: 643

Registration Number: NCT03048422

Locations: 🇧🇼
Molepolole CRS, Gaborone, Botswana
🇹🇭
Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS, Chiang Mai, Thailand
🇿🇼
St Mary's CRS, Chitungwiza, Zimbabwe

and more 18 locations