Doravirine and Weight Gain in Antiretroviral Naive

Prism Health North Texas

Overview

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.

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. .

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

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

Interventions

DOR/3TC/TDFDRUG

100 mg of doravirine (DOR), 300 mg of lamivudine (3TC), and 300 mg of TDF

DOR + FTC/TAFCOMBINATION_PRODUCT

100 mg of doravirine + 200 mg emtricitabine (FTC) and 25 mg of tenofovir alefenamide fumerate (TAF)

BIC/FTC/TAFDRUG

Bictegravir sodium 50 mg, emtricitabine 200mg, tenofovir alefenamide fumerate 25mg

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Prism Health North Texas

Dallas, Texas, United States

Outcomes

Primary Outcomes

Change from Baseline of BMI after Initiation of ART Therapy at Week 48

Comparison of weight and height is collected prior to, and during ART to determine baseline and changes of BMI (kg/m2) on ART.

Time frame: Week 48

Change of BMI Category after Initiation of ART Therapy at Week 48

Comparison of participants w/ \>10% weight change in the study arms. BMI categories: underweight (\<18.5) or normal weight (18.5 - 25) or overweight (25 - 30) or obese (\>30); or from overweight to obese.

Time frame: Week 48

Change in Regional Lean and Body Mass

Whole body Dual-energy X-ray absorptiometry (DEXA) scan (Hologic, QDR 4500A) will measure changes between study arms.

Time frame: Week 48

Data from ClinicalTrials.gov

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