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Doravirine and Weight Gain in Antiretroviral Naive

NCT05457530 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2023-05-12

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Roger Bedimo · Prism Health North Texas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2023-05-03
Completion
2023-05-03
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05457530 on ClinicalTrials.gov