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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05457530
Other study ID # 60160
Secondary ID
Status Withdrawn
Phase Phase 3
First received
Last updated
Start date August 1, 2022
Est. completion date May 3, 2023

Study information

Verified date May 2023
Source Prism Health North Texas
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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. .


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date May 3, 2023
Est. primary completion date May 3, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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


Intervention

Drug:
DOR/3TC/TDF
100 mg of doravirine (DOR), 300 mg of lamivudine (3TC), and 300 mg of TDF
Combination Product:
DOR + FTC/TAF
100 mg of doravirine + 200 mg emtricitabine (FTC) and 25 mg of tenofovir alefenamide fumerate (TAF)
Drug:
BIC/FTC/TAF
Bictegravir sodium 50 mg, emtricitabine 200mg, tenofovir alefenamide fumerate 25mg

Locations

Country Name City State
United States Prism Health North Texas Dallas Texas

Sponsors (2)

Lead Sponsor Collaborator
Prism Health North Texas Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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