This site is intended for healthcare professionals
  • Home
  • /
  • Clinical trials
  • /
  • Biktarvy
  • /
  • Safety and Efficacy of Bictegravir/Emtricitabine/T...
Clinical trial

Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naive, HIV-1 and Hepatitis B Co-Infected Adults (Alliance)

Read time: 2 mins
Last updated:30th May 2018
Identifier: NCT03547908

The primary objective of this study is to evaluate the efficacy of fixed-dose combination (FDC) of bictegravir/emtricitabine/ tenofovir alafenamide (B/F/TAF) versus dolutegravir (DTG) + emtricitabine/tenofovir disoproxil fumarate (F/TDF) in HIV and hepatitis B virus (HBV) treatment naive, HIV-1 and HBV co-infected adults.


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naïve, HIV-1 and Hepatitis B Co-Infected Adults
Actual Study Start Date: May 30, 2018
Estimated Primary Completion Date: March 2021
Estimated Study Completion Date: March 2023

Arms:
- Experimental:
B/F/TAF
- Experimental: DTG+F/TDF

Category Value
Date last updated at source 2019-06-14
Study type(s) Interventional
Expected enrolment 240
Study start date 2018-05-30
Estimated primary completion date 2021-03-01

View full details