Doravirine and Weight Gain in Antiretroviral Naive

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2023-05-03

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.

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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.

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate

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

Group Type ACTIVE_COMPARATOR

DOR/3TC/TDF

Intervention Type DRUG

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

Doravirine + Emtricitibine/Tenofovir alafenamide Fumerate

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

Group Type ACTIVE_COMPARATOR

DOR + FTC/TAF

Intervention Type COMBINATION_PRODUCT

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

Bictegravir/Emtricitibine/Tenofovir alafenamide

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

Group Type ACTIVE_COMPARATOR

BIC/FTC/TAF

Intervention Type DRUG

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

Interventions

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DOR/3TC/TDF

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

Intervention Type DRUG

DOR + FTC/TAF

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

Intervention Type COMBINATION_PRODUCT

BIC/FTC/TAF

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

Intervention Type DRUG

Other Intervention Names

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Delstrigo Pifeltro + Descovy Biktarvy

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes