Gilead Sciences, Inc. GS-US-380-4030: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching from a Regimen of Dolutegravir and Either Emtricitabine/Tenofovir Alafenamide or Emtricitabine/Tenofovir Disoproxil Fumarate to a Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Subjects who are Virologically Suppressed Save

Date Added
July 13th, 2017
PRO Number
Pro00066825
Researcher
Helmut Albrecht
Keywords
Drug Studies, HIV / AIDS, Infectious Diseases
Summary

This Phase 3 protocol is a randomized, double-blind, study evaluating the safety and efficacy of switching from a regimen of either dolutegravir (DTG) and emtricitabine (Emtriva®)/tenofovir alafenamide (Descovy®; F/TAF) or DTG and emtricitabine/tenofovir disoproxil fumarate (Truvada®; F/TDF) to a fixed dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus DTG+F/TAF in virologically suppressed HIV-1 infected adults with or without antiretroviral resistance. Male and female HIV-1 infected patients greater than or equal to 18 years of age currently receiving an ARV regimen of DTG+F/TAF or DTG+F/TDF may be eligible to participate in this study.

University of South Carolina School of Medicine
Two Medical Park, Suite 502
Columbia, SC 29203

Study Site Principal Investigator Contact Information:
Helmut Albrecht, MD at 803-540-1000

Institution
Palmetto
Recruitment Contact
Helmut Albrecht
803-540-1000
ClinicalTrialSurvey@PalmettoHealth.org

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