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Last Updated: November 21, 2019

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CLINICAL TRIALS PROFILE FOR BIKTARVY

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All Clinical Trials for Biktarvy

Trial ID Title Status Sponsor Phase Start Date Summary
NCT03499483 A Phase IV Open-label Evaluation of Safety, Tolerability, and Acceptability of a Fixed-dose Formulation of Bictegravir, Emtricitabine/Tenofovir Alafenamide (B/F/TAF) for Non-occupational Prophylaxis Following Potential Exposure to HIV-1 Not yet recruiting Fenway Community Health Phase 4 2018-05-30 Study will evaluate the safety and tolerability of once daily Biktarvy for 28 days for prevention of HIV infection in HIV-1-seronegative adults after high-risk sexual contact. (non-occupational post exposure prophylaxis - nPEP)
NCT03502005 Efficacy, Safety & Tolerability of Switching EFV/TDF/FTC to BIC/FTC/TAF in Virologically Suppressed Adults With HIV-1 Recruiting Gilead Sciences Phase 4 2018-03-01 This study evaluates the efficacy, safety and tolerability of switching from the older, established single tablet regimen of ATRIPLA® (EFV/FTC/TDF) to a new single tablet regimen of BIKTARVY® (BIC/FTC/TAF), in HIV-1 infected adult subjects who are virologically suppressed (HIV-1 RNA<50 copies/mL).
NCT03502005 Efficacy, Safety & Tolerability of Switching EFV/TDF/FTC to BIC/FTC/TAF in Virologically Suppressed Adults With HIV-1 Recruiting Midland Research Group, Inc. Phase 4 2018-03-01 This study evaluates the efficacy, safety and tolerability of switching from the older, established single tablet regimen of ATRIPLA® (EFV/FTC/TDF) to a new single tablet regimen of BIKTARVY® (BIC/FTC/TAF), in HIV-1 infected adult subjects who are virologically suppressed (HIV-1 RNA<50 copies/mL).
NCT03656783 Effects of Biktarvy on CFR in Stable HIV Patients Recruiting Boston Medical Center Phase 3 2018-09-14 Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) is a single pill regimen that was approved by the FDA in February 2018 for treatment of HIV. The marketed name of the drug is Biktarvy. In two phase 3 comparative clinical trials, including one with ABC/3TC/DTG, it was found to be non-inferior to dolutegravir-containing regimens in terms of virologic outcomes. B/F/TAF was also well tolerated, with few discontinuations for adverse events. As a result, B/F/TAF is an ideal non-abacavir containing regimen to assess the effect of removing ABC on coronary flow reserve.
NCT03656783 Effects of Biktarvy on CFR in Stable HIV Patients Recruiting Tufts Medical Center Phase 3 2018-09-14 Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) is a single pill regimen that was approved by the FDA in February 2018 for treatment of HIV. The marketed name of the drug is Biktarvy. In two phase 3 comparative clinical trials, including one with ABC/3TC/DTG, it was found to be non-inferior to dolutegravir-containing regimens in terms of virologic outcomes. B/F/TAF was also well tolerated, with few discontinuations for adverse events. As a result, B/F/TAF is an ideal non-abacavir containing regimen to assess the effect of removing ABC on coronary flow reserve.
NCT03656783 Effects of Biktarvy on CFR in Stable HIV Patients Recruiting Brigham and Women's Hospital Phase 3 2018-09-14 Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) is a single pill regimen that was approved by the FDA in February 2018 for treatment of HIV. The marketed name of the drug is Biktarvy. In two phase 3 comparative clinical trials, including one with ABC/3TC/DTG, it was found to be non-inferior to dolutegravir-containing regimens in terms of virologic outcomes. B/F/TAF was also well tolerated, with few discontinuations for adverse events. As a result, B/F/TAF is an ideal non-abacavir containing regimen to assess the effect of removing ABC on coronary flow reserve.
NCT03696160 The Late Presenter Treatment Optimisation Study Recruiting Gilead Sciences Phase 3 2019-03-05 The main purpose of this study is to compare two different types of HIV treatments, in terms of effectiveness and improvement of side effects, for patients who are diagnosed with a more advanced HIV infection. Patients with advanced HIV infections are otherwise known as 'late presenters'. There are many effective treatments for HIV available; however, for late presenting patients the investigators do not know which type of treatment performs best. This is the first large study to compare treatments for patients in this situation, and the investigators hope that the results of this study will help doctors decide which treatments to use in the future. The two different types of treatment the investigators are comparing both contain a mixture of drugs that work together to combat HIV: The Boosted Protease Inhibitor combination (PI) which is a combination tablet containing: darunavir, cobicistat, emtricitabine and tenofovir alafenamide. It was approved for use in Europe under the brand name Symtuza®. The Integrase Inhibitor combination (INI). Which is a combination tablet containing: bictegravir, emtricitabine and tenofovir alafenamide. This is a a newer combination which was approved for use in Europe in June 2018 under the brand name of Biktarvy®. The main difference between the two treatments is how each one fights a HIV infection. They both stop a part of the virus from working (i.e. inhibit it), to prevent it from making copies of itself. The PI treatment contains drugs to stop the protease part of the virus, whereas the INI treatment contains drugs to stop the integrase part. In recent studies, it appears that treatments containing integrase inhibitors may be better for late presenting patients. They have been shown to quickly bring down the amount of virus in the body, and the side effects may be more acceptable to late presenters. To compare the two treatments, half of the participants on this study will be given the PI treatment, and the other half will be given the INI treatment.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Biktarvy

Condition Name

Condition Name for Biktarvy
Intervention Trials
HIV 3
HIV-1-infection 2
HIV Prevention 1
Coronary Artery Disease 1
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Condition MeSH

Condition MeSH for Biktarvy
Intervention Trials
HIV Infections 2
Acquired Immunodeficiency Syndrome 2
Myocardial Ischemia 1
Coronary Disease 1
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Clinical Trial Locations for Biktarvy

Trials by Country

Trials by Country for Biktarvy
Location Trials
United States 6
Germany 1
Spain 1
France 1
Italy 1
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Trials by US State

Trials by US State for Biktarvy
Location Trials
Missouri 1
Georgia 1
Nebraska 1
California 1
Massachusetts 1
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Clinical Trial Progress for Biktarvy

Clinical Trial Phase

Clinical Trial Phase for Biktarvy
Clinical Trial Phase Trials
Phase 4 8
Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Biktarvy
Clinical Trial Phase Trials
Not yet recruiting 6
Recruiting 4
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Clinical Trial Sponsors for Biktarvy

Sponsor Name

Sponsor Name for Biktarvy
Sponsor Trials
Gilead Sciences 3
NEAT ID Foundation 1
Southampton Healthcare, Inc. 1
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Sponsor Type

Sponsor Type for Biktarvy
Sponsor Trials
Other 12
Industry 4
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