Doravirine and Weight Gain in Antiretroviral Naive

Obesity Clinical Trial

— DAWN  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05457530
• Other study ID #: 60160
• Status: Withdrawn
• Phase: Phase 3
• 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
• 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.

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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• Status: Withdrawn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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• ART
• BMD
• Body Weight
• Body Weight Changes
• Fasting
• HIV Infections
• Human Immunodeficiency Virus
• Metabolic Syndrome
• Minority Health
• Obesity

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