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.
Name: Dolutegravir 50 MG
Name: Antiretroviral/Anti HIV
Description: Change from baseline kilograms (kg) of weight at 24 weeks
Measure: Change in Weight Time: 24 weeksDescription: Total change in body mass index -height and weight will be combined to report BMI (Kilogram/Height in centimeters^2)
Measure: Change in body mass index (BMI) Time: 24 weeksDescription: Change from baseline vessel diameter (millimeters) at 24 weeks
Measure: Change in vascular endothelial function Time: 24 weeksDescription: Measurement of height (centimeters) from baseline to 24 weeks
Measure: Height Time: 24 weeksDescription: Change from baseline cholesterol (mg/dL) at 24 weeks
Measure: Change in cholesterol Time: 24 weeksDescription: Change from baseline triglycerides (mg/dL) at 24 weeks
Measure: Change in triglycerides Time: 24 weeksDescription: Change from baseline HDL (mg/dL) at 24 weeks
Measure: Change in high density lipoprotein (HDL) Time: 24 weeksDescription: Change from baseline LDL (mg/dL) at 24 weeks
Measure: Change in low density lipoprotein (LDL) Time: 24 weeksDescription: Change from baseline HIV-1 viral load (copies) at 24 weeks
Measure: Change in HIV-1 RNA viral load Time: 24 weeksDescription: Change from baseline serum glucose level (mg/dL) at 24 weeks
Measure: Change in fasting serum glucose level Time: 24 weeksDescription: Change from baseline of calorie consumption (kcal) at 24 weeks
Measure: Change in quantity of food consumption Time: 24 weeksAllocation: Randomized
Parallel Assignment
There are 3 SNPs
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. --- Q148H --- --- E138K ---
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. --- Q148H --- --- E138K --- --- N155H ---
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. --- Q148H ---