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

Rollover Study Protocol for Pediatric Patients in South Africa for Continued Access to Emtricitabine

Phase 2

Completed

Conditions: HIV-1 Infection

Interventions: Drug: Emtricitabine

First Posted Date: 2008-08-28

Last Posted Date: 2018-04-26

Lead Sponsor: Gilead Sciences

Target Recruit Count: 50

Registration Number: NCT00743340

Locations: 🇿🇦
Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital, Soweto, South Africa
🇿🇦
Themba Lethu Clinic, Helen Joseph Hospital, Westdene, Johannesburg, South Africa

Safety and Efficacy Study of Switching From Epzicom to Truvada

Phase 4

Completed

Conditions: HIV Infection

Interventions: Drug: emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)
Drug: abacavir (ABC)/lamivudine (3TC)

First Posted Date: 2008-07-29

Last Posted Date: 2012-05-28

Lead Sponsor: Gilead Sciences

Target Recruit Count: 312

Registration Number: NCT00724711

Locations: 🇺🇸
Peter J. Ruane, MD, Inc., Los Angeles, California, United States
🇺🇸
Anthony M Mills, MD, Los Angeles, California, United States
🇺🇸
Orange Coast Medical Group, Newport Beach, California, United States

and more 77 locations

Registry to Assess Long-term Outcome in HIV Subjects Who Participated in Phase 2 and 3 Clinical Trials Involving Vicriviroc (Study P04999)

Completed

Conditions: HIV Infections

Interventions: Drug: Vicriviroc maleate
Drug: Placebo
Drug: Emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg

First Posted Date: 2008-06-26

Last Posted Date: 2015-02-05

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 180

Registration Number: NCT00705419

Entecavir Intensification for Persistent HBV Viremia in HIV-HBV Infection

Phase 4

Completed

Conditions: HIV Infections
Hepatitis B

Interventions: Drug: Entecavir with continued standard of care antiretroviral therapy
Drug: continued standard of care with tenofovir in addition to emtricitabine or lamivudine

First Posted Date: 2008-04-21

Last Posted Date: 2013-05-27

Lead Sponsor: University of California, San Francisco

Target Recruit Count: 10

Registration Number: NCT00662545

Locations: 🇺🇸
San Francisco General HIV Clinical Trials Group, San Francisco, California, United States

An Open-Label Study of Emtricitabine in Combination With Other Antiretroviral Agents in HIV Infected Pediatric Subjects

Phase 2

Completed

Conditions: HIV Infections

Interventions: Drug: Emtricitabine

First Posted Date: 2008-03-25

Last Posted Date: 2008-04-10

Lead Sponsor: Gilead Sciences

Target Recruit Count: 16

Registration Number: NCT00642291

Determining the Effects of Observed and Self-Administered Drug Regimens in HIV Infected Adults

Not Applicable

Completed

Conditions: HIV Infections

Interventions: Drug: Lopinavir/ritonavir
Drug: Emtricitabine/Tenofovir disoproxil fumarate
Drug: Tenofovir disoproxil fumarate
Drug: Zidovudine
Drug: Emtricitabine

First Posted Date: 2008-02-06

Last Posted Date: 2018-10-12

Lead Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Target Recruit Count: 529

Registration Number: NCT00608569

Locations: 🇺🇬
JCRC CRS, Kampala, Uganda
🇭🇹
Les Centres GHESKIO CRS, Bicentenaire, Port-au-Prince, Haiti
🇵🇪
Barranco CRS, Lima, Peru

and more 6 locations

Nevirapine vs. Atazanavir Boosted With Ritonavir on a Background of Truvada in Human Immunodeficiency Virus (HIV) Infected Naive Patients (NEwArT)

Phase 4

Completed

Conditions: HIV Infections

Interventions: Drug: tenofovir DF 300 mg QD
Drug: emtricitabine 200 mg QD
Drug: Nevirapine 200 mg BID
Drug: Atazanavir 300 mg
Drug: Ritonavir 100 mg

First Posted Date: 2007-11-01

Last Posted Date: 2014-01-27

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 154

Registration Number: NCT00552240

Locations: 🇺🇸
1100.1512.24 Boehringer Ingelheim Investigational Site, Houston, Texas, United States
🇺🇸
1100.1512.20 Boehringer Ingelheim Investigational Site, Los Angeles, California, United States
🇺🇸
1100.1512.17 Boehringer Ingelheim Investigational Site, Fort Lauderdale, Florida, United States

and more 16 locations