This is an open-label, randomized pilot study to assess the effect on bone mineral density (BMD) of a switch from a tenofovir alafenamide-containing antiretroviral regimen to dolutegravir/lamivudine vs. a continuation of the tenofovir alafenamide-containing regimen.
Name: Dolutegravir (DTG) 50MG/lamivudine (3TC) 300MG FIXED DOSE COMBINATION (FDC)
Name: Current tenofovir alafenamide (TAF)-containing ART regimen
Description: Compare the percentage change from entry to 96 weeks in lumbar spine BMD in those randomized to DTG/3TC vs. those continuing a TAF-based regimen
Measure: Percent change in lumbar spine Bone Mineral Density (BMD) at 96 weeks Time: Baseline and 96 weeksDescription: Compare the percentage change from entry to 48 weeks in lumbar spine BMD in those randomized to DTG/3TC vs. those continuing a TAF-based regimen
Measure: Percentage change in lumbar spine BMD at 48 weeks Time: Baseline and 48 weeksDescription: Compare the percentage change from entry to 48 weeks in total hip BMD in those randomized to DTG/3TC vs. those continuing a TAF-based regimen
Measure: Percentage change in total hip BMD at 48 weeks Time: Baseline, 48 weeksDescription: Compare the percentage change from entry to 96 weeks in total hip BMD in those randomized to DTG/3TC vs. those continuing a TAF-based regimen
Measure: Percentage change in total hip BMD at 96 weeks Time: Baseline, 96 weeksDescription: Compare the changes in CTX from entry to 12, 48, and 96 weeks
Measure: Change in CTX (a bone resorption marker) Time: Baseline, 12 weeks, 48 weeks, and 96 weeksDescription: Compare the changes in P1NP from entry to 12, 48, and 96 weeks
Measure: Change in P1NP (a bone deposition marker) Time: Baseline, 12 weeks, 48 weeks, and 96 weeksDescription: Compare the changes in urine β2-microglobulin from entry to 48 weeks and 96 weeks.
Measure: Change in urine β2-microglobulin (renal tubular marker) Time: Baseline, 48 weeks, and 96 weeksDescription: Compare the changes in RBP from entry to 48 weeks and 96 weeks.
Measure: Change in urine RBP (renal tubular marker) Time: Baseline, 48 weeks, and 96 weeksDescription: Compare the changes in protein from entry to 48 weeks and 96 weeks.
Measure: Change in urine protein Time: Baseline, 48 weeks, and 96 weeksDescription: Compare the changes in urine albumin from entry to 48 weeks and 96 weeks.
Measure: Change in urine albumin Time: Baseline, 48 weeks, and 96 weeksDescription: Compare the changes in fractional excretion of phosphate from entry to 48 weeks and 96 weeks.
Measure: Change in fractional excretion in phosphate Time: Baseline, 48 weeks, and 96 weeksDescription: Compare the percentage change from entry to 48 weeks and 96 weeks in total lean mass (as measured by whole body DXA)
Measure: Percentage change in total lean mass Time: Baseline, 48 weeks, and 96 weeksDescription: Compare the percentage change from entry to 48 weeks and 96 weeks in trunk fat (as measured by whole body DXA)
Measure: Percentage change in trunk fat Time: Baseline, 48 weeks, and 96 weeksDescription: Compare the percentage change from entry to 48 weeks and 96 weeks in limb fat (as measured by DXA)
Measure: Percentage change in limb fat Time: Baseline, 48 weeks, and 96 weeksDescription: Compare the levels of HIV RNA <50 copies/mL and below the limit of quantification (BLQ) at 48 weeks and 96 weeks using the FDA snapshot algorithm
Measure: Maintenance of HIV RNA level Time: 48 weeks and 96 weeksDescription: Compare rates of grade 3 or 4 adverse events experienced by participants through 96 weeks
Measure: Grade 3 or 4 adverse events Time: 96 weeksDescription: Compare treatment discontinuation of study medication due to adverse effect experienced by participants through 96 weeks
Measure: Treatment discontinuation of study medication due to adverse effect Time: 96 weeksDescription: Compare changes in fasting lipids (total cholesterol, LDL, HDL, and triglycerides) at entry, 48 weeks, and 96 weeks
Measure: Change in fasting lipids Time: Entry, 48 weeks, and 96 weeksAllocation: Randomized
Parallel Assignment
There is one SNP
Any antiretroviral history (even before routine virologic monitoring became standard of care) that would suggest the presence of the M184V mutation should be considered exclusionary 7. ALT ≥5 X ULN, OR ALT ≥3xULN and bilirubin ≥1.5xULN (with >35% direct bilirubin) 8. Severe hepatic impairment (Child Pugh Class C) 9. Anticipated need for antiviral therapy for HCV 10. --- M184V ---