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Elvitegravir

Generic Name
Elvitegravir
Brand Names
Genvoya, Stribild
Drug Type
Small Molecule
Chemical Formula
C23H23ClFNO5
CAS Number
697761-98-1
Unique Ingredient Identifier
4GDQ854U53
Background

Elvitegravir is a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI) used for the treatment of HIV-1 infection in antiretroviral treatment-experienced adults. Because integrase is necessary for viral replication, inhibition prevents the integration of HIV-1 DNA into the host genome and thereby blocks the formation of the HIV-1 provirus and resulting propagation of the viral infection. Although available as a single dose tablet, elvitegravir must be used in combination with an HIV protease inhibitor coadministered with ritonavir and another antiretroviral drug.

Elvitegravir was first licensed from Japan Tobacco in 2008 and developed by Gilead Sciences. It was FDA approved on August 27, 2012. On September 24, 2014, the FDA approved the single pill form of elvitegravir.

Indication

Elvitegravir in combination with an HIV protease inhibitor coadministered with ritonavir and with other antiretroviral drug(s) is indicated for the treatment of HIV-1 infection in antiretroviral treatment-experienced adults.

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

Relative Bioavailability and Food Effect for Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: Darunavir/Cobicistat/Emtricitabine/Tenofovir alafenamide FDC
Other: High-fat Breakfast
Drug: Emtricitabine/Tenofovir alafenamide (FTC/TAF)
Other: Standardized Regular Breakfast
First Posted Date
2015-06-18
Last Posted Date
2017-10-17
Lead Sponsor
Janssen Sciences Ireland UC
Target Recruit Count
72
Registration Number
NCT02475135

Safety and Efficacy of a Switch to Doravirine, Tenofovir, Lamivudine (MK-1439A) in Human Immunodeficiency Virus (HIV-1)-Infected Participants Virologically Suppressed on an Anti-retroviral Regimen in Combination With Two Nucleoside Reverse Transcriptase Inhibitors (MK-1439A-024)

Phase 3
Completed
Conditions
HIV-1 Infection
Interventions
Drug: Baseline regimen of ritonavir- or cobicistat-boosted protease inhibitor
Drug: Baseline regimen of a non-nucleoside reverse transcriptase inhibitor
Drug: Baseline regimen of two nucleoside reverse transcriptase inhibitors
First Posted Date
2015-03-24
Last Posted Date
2024-11-20
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
673
Registration Number
NCT02397096

SSAT061: PK of DTG and EVT/COBI in Healthy Volunteers

Phase 1
Completed
Conditions
HIV
Interventions
First Posted Date
2014-08-18
Last Posted Date
2016-08-15
Lead Sponsor
St Stephens Aids Trust
Target Recruit Count
17
Registration Number
NCT02219217
Locations
🇬🇧

St Stephen's AIDS Trust, London, United Kingdom

Two Part Study to Evaluate Pharmacokinetics, Safety, and Antiviral Activity of Elvitegravir Administered With a PI/r Background Regimen for ARV Treatment-Experienced Pediatric Participants

Phase 2
Terminated
Conditions
Acquired Immune Deficiency Syndrome (AIDS)
HIV Infections
Interventions
Drug: Background regimen
First Posted Date
2013-08-15
Last Posted Date
2018-08-09
Lead Sponsor
Gilead Sciences
Target Recruit Count
31
Registration Number
NCT01923311
Locations
🇿🇦

Be Part Yoluntu Centre, Cape Town, South Africa

🇮🇹

Universita degli Studi di Pavia - Fondazione IRCCS Policlinico San Matteo, Pavia, Italy

🇺🇬

Joint Clinical Research Centre, Kampala, Uganda

and more 8 locations

Multicenter, Randomized, Double-Blind, Double-Dummy, Phase 3 Study of the Safety and Efficacy of Elvitegravir Versus Raltegravir

Phase 3
Completed
Conditions
HIV Infection
Interventions
Drug: RAL placebo
Drug: Background regimen
First Posted Date
2008-07-02
Last Posted Date
2016-05-30
Lead Sponsor
Gilead Sciences
Target Recruit Count
724
Registration Number
NCT00708162
Locations
🇺🇸

Whitman-Walker Clinic, Washington, District of Columbia, United States

🇺🇸

Orlando Immunology Center, Orlando, Florida, United States

🇺🇸

Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States

and more 176 locations

Safety of EVG+RTV Administered With Other Antiretroviral Agents for the Treatment of HIV-1 Infection

Phase 2
Completed
Conditions
HIV Infections
Interventions
Drug: ARV regimen
First Posted Date
2007-03-08
Last Posted Date
2016-04-25
Lead Sponsor
Gilead Sciences
Target Recruit Count
192
Registration Number
NCT00445146
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