Doravirine and Weight Gain in Antiretroviral Naive (DAWN)

Prism Health North Texas (PHNTX)

Status and phase: Withdrawn; Phase 3

Conditions: Human Immunodeficiency Virus; Obesity; Fasting; Minority Health; ART; BMD; Body Weight Changes; Metabolic Syndrome

Treatments: Drug: BIC/FTC/TAF; Combination Product: DOR + FTC/TAF; Drug: DOR/3TC/TDF

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05457530

60160

Details and patient eligibility

About

The purpose of this study is determine whether different antiretroviral therapy (ART) changes the effects on body fat and predict the weight change in Black and Hispanic females.

Full description

Study is three-arm, open-label, randomized, interventional trial, in which all patients who are successfully enrolled will be randomized 1:1:1 to initiate ART therapy with Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate vs. Doravirine + Emtricitabine/Tenofovir Alefenamide, Bictegravir/Emtricitabine/Tenofovir Alafenamide. All patients will be followed or a total o 48 weeks.

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Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 years or older;
• No prior exposure to antiretroviral therapy for >7 days prior to study entry;
• Plasma HIV1 RNA concentration >/=5000 copies/mL;
• CD4 T cell count >/=200 cells/µL.
• For persons capable of becoming pregnant, negative serum or urine pregnancy test within 45 days prior to entry
• Ability and willingness of participant or legal guardian/representative to provide informed consent

Exclusion criteria

• Evidence of resistance to DOR, TDF, 3TC/FTC or BIC.
• Creatinine clearance <60 mL/min
• Use of weight loss agents or plans to initiate weight loss program (diet or exercise-based)
• Known allergy/sensitivity or any hypersensitivity to components of study drug(s) or their formulation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate

Active Comparator group

Description:

Participants to receive DOR/3TC/TDF tablet once daily for 48 weeks

Treatment:

Drug: DOR/3TC/TDF

Doravirine + Emtricitibine/Tenofovir alafenamide Fumerate

Active Comparator group

Description:

Participants to receive DOR + FTC/TAF tablets once daily for 48 weeks

Treatment:

Combination Product: DOR + FTC/TAF

Bictegravir/Emtricitibine/Tenofovir alafenamide

Active Comparator group

Description:

Participants to receive BIC/FTC/TAF tablet once daily for 48 weeks

Treatment:

Drug: BIC/FTC/TAF