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Generated: June 26, 2019

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CLINICAL TRIALS PROFILE FOR BIKTARVY

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Clinical Trials for Biktarvy

Trial ID Title Status Sponsor Phase 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 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 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 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 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 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 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.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Biktarvy

Condition Name

Condition Name for Biktarvy
Intervention Trials
HIV 1
Bone Loss 1
Acute HIV Infection 1
Human Immunodeficiency Virus 1
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Condition MeSH

Condition MeSH for Biktarvy
Intervention Trials
HIV Infections 2
Acquired Immunodeficiency Syndrome 2
Infection 1
Immunologic Deficiency Syndromes 1
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Clinical Trial Locations for Biktarvy

Trials by Country

Trials by Country for Biktarvy
Location Trials
United States 3
Italy 1
Belgium 1
Ireland 1
United Kingdom 1
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Trials by US State

Trials by US State for Biktarvy
Location Trials
California 1
Massachusetts 1
Florida 1
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Clinical Trial Progress for Biktarvy

Clinical Trial Phase

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

Clinical Trial Status for Biktarvy
Clinical Trial Phase Trials
Not yet recruiting 3
Recruiting 3
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Clinical Trial Sponsors for Biktarvy

Sponsor Name

Sponsor Name for Biktarvy
Sponsor Trials
Gilead Sciences 2
Boston Medical Center 1
MU-JHU CARE 1
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Sponsor Type

Sponsor Type for Biktarvy
Sponsor Trials
Other 8
Industry 3
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