Clinical trial

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

Name

60160

Description

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.

Trial arms

Trial start

2022-08-01

Estimated PCD

2023-05-03

Trial end

2023-05-03

Status

Withdrawn

Phase

Early phase I

Treatment

DOR/3TC/TDF

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

Arms:

Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate

Other names:

Delstrigo

DOR + FTC/TAF

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

Arms:

Doravirine + Emtricitibine/Tenofovir alafenamide Fumerate

Other names:

Pifeltro + Descovy

BIC/FTC/TAF

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

Arms:

Bictegravir/Emtricitibine/Tenofovir alafenamide

Other names:

Biktarvy

Primary endpoint

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

Week 48

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

Week 48

Change in Regional Lean and Body Mass

Week 48

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}

Updated at

2023-05-12

1 organization

3 products

8 indications

Organization

Prism Health North Texas

Product

DOR/3TC/TDF

Indication

Body Weight Changes

Indication