An Open-Label Study to Evaluate Switching from a Regimen of Elvitegravir/Tenofovir alafenamide/Emtricitabine/Cobicistat and Darunavir, to a Fixed-Dose Combination of Bictegravir/Tenofovir alafenamide/Emtricitabine in Virologically Suppressed HIV-1 Subjects who are known to have a I84 V/I Mutation
An Open-Label Study to Evaluate Switching from a Regimen of Elvitegravir/Tenofovir alafenamide/Emtricitabine/Cobicistat and Darunavir, to a Fixed-Dose Combination of Bictegravir/Tenofovir alafenamide/Emtricitabine in Virologically Suppressed HIV-1 Subjects who are known to have a I84 V/I Mutation
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Antiretroviral drug
Southampton Healthcare, Inc.
St Louis, Missouri, United States
Test the safety and effectiveness of the drug Biktarvy in subjects known to have the 184 V/I resistance mutation.
Pure Virologic Response (PVR) with HIV-1 RNA \< 50 copies/mL at week 12.
Time frame: In 48 week study
Test the safety and effectiveness of the drug Biktarvy in subjects known to have the 184 V/I resistance mutation.
Pure Virologic Response (PVR) with HIV-1 RNA \< 50 copies/mL at week 24.
Time frame: In 48 Week study
Test the safety and effectiveness of the drug Biktarvy in subjects known to have the 184
Pure Virologic Response (PVR) with HIV-1 RNA \< 50 copies/mL at week 48
Time frame: 48 Weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.