Doravirine and Weight Gain in Antiretroviral Naive

Study Overview
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Brief Summary
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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
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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. .

Official Title
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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

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

Intervention / Treatment
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* Drug: DOR/3TC/TDF
* Combination Product: DOR + FTC/TAF
* Drug: BIC/FTC/TAF


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Week 48 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment Naive, African American Women, Hispanic Women, Fasting Glucose, Fasting Insuline, Negative pregnancy test, 18 years or older