WithdrawnPhase 3

Doravirine and Weight Gain in Antiretroviral Naive

Stopped: Due to No/Low enrollment

United States0Started 2022-08-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from Baseline of BMI after Initiation of ART Therapy at Week 48

Timeframe: Week 48

Change of BMI Category after Initiation of ART Therapy at Week 48

Timeframe: Week 48

Change in Regional Lean and Body Mass

Timeframe: Week 48

Trial details

NCT IDNCT05457530

SponsorPrism Health North Texas

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-05-03

View on ClinicalTrials.gov More Body Weight Changes trials

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.