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 range18 Years – 100 Years
SexALL
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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…