Contribution of Dolutegravir to Obesity and Cardiovascular Disease (NCT04340388) | Clinical Trial Compass
CompletedPhase 4
Contribution of Dolutegravir to Obesity and Cardiovascular Disease
United States10 participantsStarted 2020-09-17
Plain-language summary
The goal of the study is to combine a collaborative and translational approach to evaluate the effect antiretroviral regimen switch to a dolutegravir containing regimen compared to continued treatment with a non- dolutegravir based regimen on on lipid and metabolic profiles, renal function, body composition, vascular function and diet.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
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:
Subjects must meet the following criteria to be eligible for participation in this study:
* Age greater than or equal to 18 years with HIV-1 who have been virologically suppressed (HIV-1 RNA \< 50 copies for greater than or equal to 3 months on a non-integrase strand transfer inhibitor-based regimen
* Have the ability to understand and sign an informed consent written in the English language
Exclusion Criteria:
Subjects meeting any of the following exclusion criteria are not to be enrolled in this study:
* Age less than 18 years without HIV-1 infection
* Has hypersensitivity or other contraindication to any of the components of the study
* Has active diagnosis of untreated hepatitis due to any cause
* Has a history or current evidence of any condition, laboratory abnormality or other circumstance ( including drug or alcohol use or dependence) that might confound the results of the study or interfere with the subject's participation for the full duration of the study
* Is taking or is anticipated to require long term systemic immunosuppressive therapy, immune modulators, or any prohibited therapies from 60 days prior to Screening/Day 1 visit through to the end of study
* Has documented or suspected dolutegravir-associated resistance mutations specifically:
Q148H/K/R/N in combination with E138K or G1402/A or N155H.
* Has a life expectancy less than or equal to one year
* Is pregnant, breastfeeding, or expecting to donate eggs or sperm or conceive or f…
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.