NCT05457530

Doravirine and Weight Gain in Antiretroviral Naive

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

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Prism Health North Texas · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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. .

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-08-01
• Primary completion: 2023-05-03
• Completion: 2023-05-03
• First posted: 2022-07-14
• Last updated: 2023-05-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study