Efficacy, Safety & Tolerability of Switching EFV/TDF/FTC to BIC/FTC/TAF in Virologically Suppressed Adults With HIV-1
NCT03502005 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2024-09-19
Summary
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).
Conditions
- Human Immunodeficiency Virus
Interventions
- DRUG
-
bictegravir/emtricitabine/tenofovir alafenamide
Discontinue ATRIPLA® and initiate BIKTARVY®
Sponsors & Collaborators
- collaborator INDUSTRY
-
Midland Research Group, Inc.
lead OTHER
Principal Investigators
-
Noah Lee, DO · Midland Research Group, Inc.
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-03-01
- Primary Completion
- 2019-12-30
- Completion
- 2019-12-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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