Doravirine and Weight Gain in Antiretroviral Naive

Phase 3

Withdrawn

• Conditions: Body Weight Changes; Minority Health; BMD; Fasting; Human Immunodeficiency Virus; Metabolic Syndrome; ART; Obesity
• Interventions: Drug: DOR/3TC/TDF; Combination Product: DOR + FTC/TAF; Drug: BIC/FTC/TAF

• Registration Number: NCT05457530
• Lead Sponsor: Prism Health North Texas

Brief Summary

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.

Detailed 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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Study Timeline

• Study First Submitted: 2022-04-15
• Study First Submitted QC: 2022-07-12
• Study First Posted: 2022-07-14
• Study Start: 2022-08-01
• Status Verified: 2023-05
• Primary Completion: 2023-05-03
• Study Completion: 2023-05-03
• Last Update Submitted: 2023-05-10
• Last Update Posted: 2023-05-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate	DOR/3TC/TDF	Participants to receive DOR/3TC/TDF tablet once daily for 48 weeks
Doravirine + Emtricitibine/Tenofovir alafenamide Fumerate	DOR + FTC/TAF	Participants to receive DOR + FTC/TAF tablets once daily for 48 weeks
Bictegravir/Emtricitibine/Tenofovir alafenamide	BIC/FTC/TAF	Participants to receive BIC/FTC/TAF tablet once daily for 48 weeks

Primary Outcome Measures

Name	Time	Method
Change from Baseline of BMI after Initiation of ART Therapy at Week 48	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.
Change of BMI Category after Initiation of ART Therapy at Week 48	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.
Change in Regional Lean and Body Mass	Week 48	Whole body Dual-energy X-ray absorptiometry (DEXA) scan (Hologic, QDR 4500A) will measure changes between study arms.

Trial Locations

Locations (1)

Prism Health North Texas; 🇺🇸 Dallas, Texas, United States