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

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

Completed

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: 2025-02-06

Lead Sponsor: Duke University

Target Recruit Count: 164

Registration Number: NCT04862975

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

and more 1 locations

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

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC
Drug: Darunavir
Drug: Emtricitabine/Tenofovir Alafenamide
Drug: Cobicistat

First Posted Date: 2020-12-10

Last Posted Date: 2025-02-03

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 37

Registration Number: NCT04661397

Locations: 🇳🇱
PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini, Groningen, Netherlands

Emtricitabine/Tenofovir Alafenamide Switch Study for Transgender Individuals for HIV Pre-exposure Prophylaxis

Phase 4

Active, not recruiting

Conditions: Hiv
Hormone Therapy

Interventions: Drug: Emtricitabine / Tenofovir Disoproxil Oral Tablet 200/300 mg
Drug: Emtricitabine Tenofovir Alafenamide 200/25 mg

First Posted Date: 2020-11-05

Last Posted Date: 2023-05-06

Lead Sponsor: University of California, San Diego

Target Recruit Count: 64

Registration Number: NCT04616963

Locations: 🇺🇸
UC San Diego AntiViral Research Center (AVRC), San Diego, California, United States

Assessment of Drug-drug Interactions Between Masculinizing Hormone Therapy and Antiretroviral Agents Concomitantly for Pre-exposure Prophylaxis Among Transgender Men

Not Applicable

Active, not recruiting

Conditions: Drug Interaction

Interventions: Drug: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg (F/TDF) and emtricitabine 200 mg/tenofovir alafenamide 25 mg (F/TAF)

First Posted Date: 2020-10-20

Last Posted Date: 2024-11-25

Lead Sponsor: Thai Red Cross AIDS Research Centre

Target Recruit Count: 20

Registration Number: NCT04593680

Locations: 🇹🇭
Institute of HIV Research and Innovation (IHRI), Bangkok, Pathumwan, Thailand

Dose Ranging, Switch Study of Islatravir (ISL) and Ulonivirine (MK-8507) Once-Weekly in Virologically-Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) [MK-8591-013]

Phase 2

Completed

Conditions: HIV-1 Infection

Interventions: Drug: Islatravir
Drug: BIC/FTC/TAF
Drug: Ulonivirine
Drug: Placebo to ISL
Drug: Placebo to Ulonivirine
Drug: Placebo to BIC/FTC/TAF

First Posted Date: 2020-09-25

Last Posted Date: 2025-02-12

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 161

Registration Number: NCT04564547

Locations: 🇺🇸
Men's Health Foundation ( Site 2710), Los Angeles, California, United States
🇺🇸
Kansas City CARE Clinic ( Site 2703), Kansas City, Missouri, United States
🇺🇸
Chatham County Health Department ( Site 2707), Savannah, Georgia, United States

and more 20 locations

Efficacy of Dolutegravir Plus Lamivudine in HIV-1-infected Treatment-naïve Adults Without a Baseline Genotyping Test

Phase 4

Completed

Conditions: Hiv
HIV-1-infection

Interventions: Drug: Emtricitabine / Tenofovir Disoproxil Pill
Drug: Lamivudine 300 MG

First Posted Date: 2020-09-16

Last Posted Date: 2024-02-21

Lead Sponsor: Fundacion IDEAA

Target Recruit Count: 244

Registration Number: NCT04549467

Locations: 🇦🇷
Fundacion IDEAA, Buenos Aires, Argentina

Daily Regimen of Tenofovir/Emtricitabine as Prevention for COVID-19 in Health Care Personnel in Colombia

Phase 2

Conditions: Severe Acute Respiratory Syndrome Coronavirus 2
COVID-19

Interventions: Drug: Tenofovir/ Emtricitabine ( 300 mg / 200 mg daily during 60 days) + Personal Protective Equipment (PPE)
Other: Placebo (1 tablet daily during 60 days) + Personal Protective Equipment (PPE)

First Posted Date: 2020-08-19

Last Posted Date: 2020-08-19

Lead Sponsor: Hospital Universitario San Ignacio

Target Recruit Count: 950

Registration Number: NCT04519125

Repurposing Nucleoside Reverse Transcriptase Inhibitors for Treatment of AD

Phase 1

Recruiting

Conditions: Alzheimer Disease, Early Onset
Mild Cognitive Impairment
Moderate Dementia

Interventions: Drug: Emtriva Capsule
Drug: Placebo

First Posted Date: 2020-08-05

Last Posted Date: 2025-05-04

Lead Sponsor: Butler Hospital

Target Recruit Count: 35

Registration Number: NCT04500847

Locations: 🇺🇸
Cedars-Sinai Medical Center, Los Angeles, California, United States
🇺🇸
Memory and Aging Program, Butler Hospital, Providence, Rhode Island, United States