Contribution of Dolutegravir to Obesity and Cardiovascular Disease
HIV-1-infection, Antiviral Drug Adverse Reaction, Vascular Diseases
About this trial
This is an interventional basic science trial for HIV-1-infection
Eligibility Criteria
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 father a child at any time during the study and 6 weeks following the end of study.
Sites / Locations
- Augusta University
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Switch from a non-integrase based regimen to dolutegravir
Continue on non-integrase inhibitor based regimen
Participants with HIV-1 infection who have had viral suppression on a non-integrase based antiretroviral regimen for greater than or equal to 3 months will be switched to a dolutegravir based regimen dosed at 50 milligrams (MG) once daily. Background regimen will remain the same.
Participants not currently on an integrase based regimen who remain on current suppressive therapy will remain on current antiretroviral regimen.