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 of Islatravir (ISL) and Ulonivirine (ULO) Once Weekly (QW) in Virologically Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8591B-060)

Phase 2

Recruiting

Conditions: Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Interventions: Drug: ISL
Drug: BIC/FTC/TAF
Drug: ULO

First Posted Date: 2025-03-24

Last Posted Date: 2025-05-13

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 150

Registration Number: NCT06891066

Locations: 🇺🇸
Georgetown University Medical Center ( Site 4106), Washington, District of Columbia, United States
🇵🇷
Ponce Medical School Foundation Inc./CAIMED Center ( Site 4301), Ponce, Puerto Rico
🇵🇷
Clinical Research Puerto Rico ( Site 4300), San Juan, Puerto Rico

and more 18 locations

Single Ascending Dose, Food Effects and Drug-Drug Interactions of ACC017 Tablets in Healthy Adult Participants

Phase 1

Recruiting

Conditions: Healthy Adult Participants

Interventions: Drug: ACC017 tablets
Drug: Emtricitabine and Tenofovir Alafenamide Fumarate Tablets

First Posted Date: 2024-02-26

Last Posted Date: 2024-03-05

Lead Sponsor: Jiangsu Aidea Pharmaceutical Co., Ltd

Target Recruit Count: 52

Registration Number: NCT06278389

Locations: 🇨🇳
Beijing Ditan Hospital Capital Medical University, Beijing, China

Study of Bictegravir/Emtricitavine/Tenofovir Alafenamide in HIV-1 Infected naïve Patients Using Test and Treat Stategy Rapid-initiation Model of Care: BIC-NOW Clinical Trial (BIC-NOW)

Phase 4

Completed

Conditions: HIV Infections

Interventions: Drug: BIC/FTC/TAF

First Posted Date: 2023-12-20

Last Posted Date: 2023-12-20

Lead Sponsor: Carmen Hidalgo Tenorio

Target Recruit Count: 208

Registration Number: NCT06177574

Locations: 🇪🇸
H JEREZ, Jerez De La Frontera, Cádiz, Spain
🇪🇸
Hospital Campus de la Salud, Granada, Spain
🇪🇸
Complejo Hospitalario de Jaén,, Jaén, Spain

and more 12 locations

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

DOR/ISL in HIV-1 Antiretroviral Treatment-naïve Participants (MK-8591A-053)

Phase 3

Active, not recruiting

Conditions: HIV-1 Infection

Interventions: Drug: DOR/ISL
Drug: BIC/FTC/TAF
Drug: Placebo to BIC/FTC/TAF
Drug: Placebo to DOR/ISL

First Posted Date: 2023-01-30

Last Posted Date: 2024-10-21

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 500

Registration Number: NCT05705349

Locations: 🇺🇸
Pueblo Family Physicians ( Site 5674), Phoenix, Arizona, United States
🇺🇸
Pacific Oaks Medical Group ( Site 5681), Beverly Hills, California, United States
🇺🇸
Ruane Clinical Research Group, Inc ( Site 5658), Los Angeles, California, United States

and more 128 locations

A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-052)

Phase 3

Active, not recruiting

Conditions: HIV-1 Infection

Interventions: Drug: DOR/ISL
Drug: BIC/FTC/TAF
Drug: Placebo to BIC/FTC/TAF
Drug: Placebo to DOR/ISL

First Posted Date: 2022-11-30

Last Posted Date: 2024-11-07

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 514

Registration Number: NCT05630755

Locations: 🇺🇸
North Texas Infectious Diseases Consultants, P.A ( Site 1404), Dallas, Texas, United States
🇨🇱
Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 2205), Temuco, Araucania, Chile
🇨🇱
Universidad de Chile - Hospital Clínico Universidad de Chile-Inmunologia Alergia y VIH ( Site 2200), Santiago, Region M. De Santiago, Chile

and more 46 locations

Doravirine and Weight Gain in Antiretroviral Naive

Phase 3

Withdrawn

Conditions: Body Weight Changes
Minority Health
BMD
Fasting
Human Immunodeficiency Virus
Metabolic Syndrome
ART
Obesity

Interventions: Drug: DOR/3TC/TDF
Combination Product: DOR + FTC/TAF
Drug: BIC/FTC/TAF

First Posted Date: 2022-07-14

Last Posted Date: 2023-05-12

Lead Sponsor: Prism Health North Texas

Registration Number: NCT05457530

Locations: 🇺🇸
Prism Health North Texas, Dallas, Texas, United States

Project Engage: Oral PrEP Acceptability

Phase 2

Completed

Conditions: Adherence, Medication
Acceptability of Health Care

Interventions: Drug: emtricitabine/tenofovir alafenamide
Drug: Emtricitabine / Tenofovir Disoproxil Oral Tablet

First Posted Date: 2022-07-14

Last Posted Date: 2024-07-29

Lead Sponsor: Eastern Virginia Medical School

Target Recruit Count: 330

Registration Number: NCT05458765

Locations: 🇿🇼
Harare Health and Research Consortium (HHRC), Harare, Zimbabwe
🇿🇦
MatCH Research Unit, Durban, KZN, South Africa
🇿🇦
CAPRISA Vulindlela, Pietermaritzburg, KZN, South Africa

Pre-Exposure Prophylaxis Study of Lenacapavir and Emtricitabine/Tenofovir Alafenamide in Adolescent Girls and Young Women at Risk of HIV Infection

Phase 3

Active, not recruiting

Conditions: Pre-Exposure Prophylaxis of HIV Infection

Interventions: Drug: Oral Lenacapavir (LEN)
Drug: F/TAF
Drug: F/TDF
Drug: Subcutaneous (SC) Lenacapavir (LEN)
Drug: Placebo SC LEN
Drug: PTM F/TDF
Drug: PTM F/TAF
Drug: PTM Oral LEN

First Posted Date: 2021-08-06

Last Posted Date: 2025-02-24

Lead Sponsor: Gilead Sciences

Target Recruit Count: 5368

Registration Number: NCT04994509

Locations: 🇿🇦
Emavundleni Research Centre, Cape Town, South Africa
🇿🇦
The Aurum Institute: Rustenburg Clinical Research Centre, Rustenburg, South Africa
🇿🇦
Synergy Biomed Research Institute (SBRI), East London, South Africa

and more 25 locations

Study of Lenacapavir for HIV Pre-Exposure Prophylaxis in People Who Are at Risk for HIV Infection

Phase 3

Active, not recruiting

Conditions: Pre-Exposure Prophylaxis of HIV Infection

Interventions: Drug: Oral Lenacapavir (LEN)
Drug: F/TDF
Drug: Sub-cutaneous (SC) Lenacapavir (LEN)
Drug: Placebo SC LEN
Drug: F/TAF (for US participants only)
Drug: PTM F/TDF
Drug: PTM Oral LEN

First Posted Date: 2021-06-14

Last Posted Date: 2024-12-20

Lead Sponsor: Gilead Sciences

Target Recruit Count: 3295

Registration Number: NCT04925752

Locations: 🇺🇸
The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles, California, United States
🇺🇸
Howard Brown Health Center, Chicago, Illinois, United States
🇺🇸
The Crofoot Research Center, INC, Houston, Texas, United States

and more 87 locations

Drug Development Updates

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