DAWN: Doravirine and Weight Gain in Antiretroviral Naive

Sponsor

Prism Health North Texas (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05457530

Collaborator

Merck Sharp & Dohme LLC (Industry)

150

Enrollment

Location

Arms

Anticipated Duration (Months)

4.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Body Weight Changes Human Immunodeficiency Virus ART Obesity Minority Health BMD Metabolic Syndrome Fasting	Drug: DOR/3TC/TDF Combination Product: DOR + FTC/TAF Drug: BIC/FTC/TAF	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effect of Modified, Rapid-start, DOR/3TC/TDF or DOR + FTC/TAF or BIC/FTC/TAF on Body Weight and Composition, Metabolic Risk Parameters, and Measures of Bone Strength in Treatment-Naïve Black and Hispanic Women With HIV-1 Infection

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jun 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate Participants to receive DOR/3TC/TDF tablet once daily for 48 weeks	Drug: DOR/3TC/TDF 100 mg of doravirine (DOR), 300 mg of lamivudine (3TC), and 300 mg of TDF Other Names: Delstrigo
Active Comparator: Doravirine + Emtricitibine/Tenofovir alafenamide Fumerate Participants to receive DOR + FTC/TAF tablets once daily for 48 weeks	Combination Product: DOR + FTC/TAF 100 mg of doravirine + 200 mg emtricitabine (FTC) and 25 mg of tenofovir alefenamide fumerate (TAF) Other Names: Pifeltro + Descovy
Active Comparator: Bictegravir/Emtricitibine/Tenofovir alafenamide Participants to receive BIC/FTC/TAF tablet once daily for 48 weeks	Drug: BIC/FTC/TAF Bictegravir sodium 50 mg, emtricitabine 200mg, tenofovir alefenamide fumerate 25mg Other Names: Biktarvy

Arm

Intervention/Treatment

Active Comparator: Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate

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

Drug: DOR/3TC/TDF

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

Other Names:

Delstrigo

Active Comparator: Doravirine + Emtricitibine/Tenofovir alafenamide Fumerate

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

Combination Product: DOR + FTC/TAF

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

Other Names:

Pifeltro + Descovy

Active Comparator: Bictegravir/Emtricitibine/Tenofovir alafenamide

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

Drug: BIC/FTC/TAF

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

Other Names:

Biktarvy

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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