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Emtricitabine

Generic Name
Emtricitabine
Brand Names
Atripla, Biktarvy, Complera, Descovy, Emtriva, Genvoya, Odefsey, Stribild, Truvada
Drug Type
Small Molecule
Chemical Formula
C8H10FN3O3S
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)

A Comparison of Two Anti-HIV Drug Regimens for Youth Who Have Failed Prior Therapy

Phase 2
Completed
Conditions
HIV Infections
First Posted Date
2005-01-26
Last Posted Date
2021-11-01
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
6
Registration Number
NCT00102206
Locations
🇺🇸

Columbia IMPAACT CRS, New York, New York, United States

🇺🇸

Chicago Children's CRS, Chicago, Illinois, United States

🇺🇸

SUNY Stony Brook NICHD CRS, Stony Brook, New York, United States

and more 1 locations

NNRTI vs PI Regimens for HIV Infected Women After They Have Taken Nevirapine to Prevent Mother-To-Child HIV Transmission

Phase 3
Completed
Conditions
HIV Infections
Interventions
Drug: Emtricitabine
Drug: Emtricitabine/Tenofovir disoproxil fumarate
Drug: Nevirapine
Drug: Lopinavir/Ritonavir
Drug: Tenofovir disoproxil fumarate
First Posted Date
2004-08-06
Last Posted Date
2018-10-12
Lead Sponsor
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Target Recruit Count
745
Registration Number
NCT00089505
Locations
🇿🇦

University of Witwatersrand, Johannesburg, South Africa

🇧🇼

The Gaborone BHP Study Clinic, Bontleng, Gaborone, Botswana

🇿🇲

Centre for Infectious Disease Research in Zambia (CIDRZ), Lusaka, Zambia

and more 8 locations

Three Month Course of Anti-HIV Medications for People Recently Infected With HIV

Not Applicable
Withdrawn
Conditions
HIV Infections
First Posted Date
2004-07-13
Last Posted Date
2021-11-01
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Registration Number
NCT00087464

Prospective Evaluation of Anti-retroviral Combinations for Treatment Naive, HIV Infected Persons in Resource-limited Settings

Phase 4
Completed
Conditions
HIV Infections
Interventions
Drug: Efavirenz
Drug: Atazanavir
Drug: Didanosine (enteric-coated)
Drug: Lamivudine/Zidovudine
Drug: Emtricitabine/Tenofovir disoproxil fumarate
Drug: Emtricitabine
First Posted Date
2004-06-08
Last Posted Date
2018-10-10
Lead Sponsor
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Target Recruit Count
1571
Registration Number
NCT00084136
Locations
🇺🇸

University of Texas, Galveston, Galveston, Texas, United States

🇲🇼

College of Med. JHU CRS, P.O. Box 1131, Blantyre, Malawi

🇿🇼

UZ-Parirenyatwa CRS, AIDS Research Unit P.O. Box A178, Harare, Zimbabwe

and more 39 locations

Effect of an Enfuvirtide-based Anti-HIV Drug Regimen on Latent HIV Reservoirs in Treatment Naive Adults

First Posted Date
2003-01-20
Last Posted Date
2021-11-01
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
19
Registration Number
NCT00051831
Locations
🇺🇸

University of Colorado Hospital CRS, Aurora, Colorado, United States

🇺🇸

Massachusetts General Hospital ACTG CRS, Boston, Massachusetts, United States

🇺🇸

Washington U CRS, Saint Louis, Missouri, United States

and more 4 locations

Study of Lopinavir, Ritonavir, Tenofovir and Emtricitabine in HIV-Infected Antiretroviral Naïve Subjects

Phase 3
Completed
Conditions
HIV Infections
First Posted Date
2002-08-19
Last Posted Date
2006-07-27
Lead Sponsor
Abbott
Target Recruit Count
200
Registration Number
NCT00043966
Locations
🇺🇸

Phoenix Body Positive, Phoenix,, Arizona, United States

🇺🇸

Akron Infectious Disease, Inc., Akron, Ohio, United States

🇺🇸

Donna E. Sweet, MD, Wichita,, Kansas, United States

and more 49 locations

Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy

Completed
Conditions
HIV Infections
Interventions
Drug: darunavir/ritonavir dosage #1
Drug: TAF w/cobicistat
Drug: TAF w/cobicistat or ritonavir
Drug: tenofovir alafenamide fumarate (TAF)
Drug: elvitegravir/cobicistat
Drug: darunavir/cobicistat
Drug: atazanavir/cobicistat
Drug: lopinavir/ritonavir dosage #1
Drug: atazanavir/ritonavir/tenofovir dosage #1
Drug: lopinavir/ritonavir dosage #2
Drug: indinavir/ritonavir dosage #1
Drug: fosamprenavir/ritonavir
Drug: atazanavir/ritonavir dosage #1
Drug: didanosine delayed release (Videx® EC)
Drug: emtricitabine
Drug: nelfinavir dosage #1
Drug: tipranavir/ritonavir
Drug: etravirine
Drug: darunavir/ritonavir dosage #4
Drug: indinavir/ritonavir dosage #2
Drug: rilpivirine
Drug: ethambutol
Drug: efavirenz
Drug: raltegravir
Drug: dolutegravir
Drug: kanamycin
Drug: nevirapine
Drug: amprenavir
Drug: abacavir
Drug: tenofovir
Drug: maraviroc
Drug: nelfinavir dosage #2
Drug: darunavir/ritonavir dosage #2
Drug: lopinavir/ritonavir dosage #3
Drug: lopinavir/ritonavir dosage #4
Drug: tenofovir/atazanavir/ritonavir dosage #2
Drug: atazanavir/ritonavir dosage #2
Drug: rifampicin
Drug: amikacin
Drug: etonogestrel implant
Drug: darunavir/ritonavir dosage #3
Drug: capreomycin
Drug: ethinyl estradiol
Drug: isoniazid
Drug: moxifloxacin
Drug: levoflaxacin
Drug: pyrazinamide
Drug: ofloxacin
Drug: ethionamide/prothionamide
Drug: terizidone/cycloserine
Drug: para-aminosalicylic acid (PAS)
Drug: high dose INH
Drug: bedaquiline
Drug: clofazamine
Drug: delamanid
Drug: linezolid
Drug: pretomanid
First Posted Date
2002-08-01
Last Posted Date
2022-07-22
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
1578
Registration Number
NCT00042289
Locations
🇺🇸

Usc La Nichd Crs, Los Angeles, California, United States

🇿🇦

Wits RHI Shandukani Research Centre CRS, Johannesburg, Gauteng, South Africa

🇺🇸

Boston Medical Center Ped. HIV Program NICHD CRS, Boston, Massachusetts, United States

and more 59 locations

A Study to Compare Anti-HIV Drugs Given Twice a Day or Once a Day, With or Without Direct Observation

Phase 2
Completed
Conditions
HIV Infections
First Posted Date
2002-05-13
Last Posted Date
2021-11-01
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
402
Registration Number
NCT00036452
Locations
🇺🇸

The Ohio State Univ. AIDS CRS, Columbus, Ohio, United States

🇺🇸

MetroHealth CRS, Cleveland, Ohio, United States

🇺🇸

Pitt CRS, Pittsburgh, Pennsylvania, United States

and more 26 locations

Comparing FTC and Lamivudine in HIV-Infected Patients on a Stable Anti-HIV Drug Combination

Phase 3
Completed
Conditions
HIV Infections
First Posted Date
2001-08-31
Last Posted Date
2005-06-24
Lead Sponsor
Triangle Pharmaceuticals
Target Recruit Count
390
Registration Number
NCT00002416
Locations
🇺🇸

Dr Robert Wallace, St. Petersburg, Florida, United States

🇺🇸

North Shore Univ Hosp, Great Neck, New York, United States

The Safety and Effectiveness of 524W91

Phase 1
Completed
Conditions
HIV Infections
First Posted Date
2001-08-31
Last Posted Date
2005-06-24
Lead Sponsor
Glaxo Wellcome
Target Recruit Count
18
Registration Number
NCT00002335
Locations
🇺🇸

ViRx Inc, San Francisco, California, United States

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