Doravirine and Weight Gain in Antiretroviral Naive

Withdrawn before enrolling · Phase 3

Conditions studied: Body Weight Changes, Human Immunodeficiency Virus, ART, Obesity, Minority Health, BMD, Metabolic Syndrome, Fasting

In brief

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.

Key facts

Study ID

NCT05457530

Run by

Prism Health North Texas

People needed

0

Starts

2022-08-01

Expected to finish

2023-05-03

Last updated by the study team

2023-05-12

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Prism Health North Texas — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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