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DAWN: Doravirine and Weight Gain in Antiretroviral Naive Women
NCT05457530Phase 3
Key facts
- Status
- Withdrawn
- Start
- Aug 2022
- Primary completion
- May 2023
- Countries
- 1
- Sponsor
- Prism Health North Texas
- Modality
- Small Molecules
- Drugs
- doravirine
- Conditions
- human immunodeficiency virus type 1 infection (HIV-1)
01
Overview
Phase 3, randomised, open-label trial of doravirine in human immunodeficiency virus type 1 infection (HIV-1) (3 arms), sponsored by Prism Health North Texas. Primary endpoints: Change from Baseline of BMI after Initiation of ART Therapy at 48 weeks, Change of BMI Category after Initiation of ART Therapy at 48 weeks and 1 more. Planned start Aug 2022; status: withdrawn.
02
Design
3 arms- Study design
- RandomizedOpen-label
DOR/3TC/TDF
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate once daily
DOR + FTC/TAF
Doravirine + Emtricitabine/Tenofovir Alafenamide once daily
BIC/FTC/TAF
Bictegravir/Emtricitabine/Tenofovir Alafenamide once daily
03
Who it enrols
Treatment-naïve Black and Hispanic women with HIV-1 infection, viral load >= 5000 copies/mL, and CD4 >= 200 cells/µL.
04
Endpoints
Primary
Change from Baseline of BMI after Initiation of ART Therapy
Change of BMI Category after Initiation of ART Therapy
Change in Regional Lean and Body Mass
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