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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Participants randomized to the Switch Arm will take DTG 50mg/3TC 300mg FDC once daily with or without food at approximately the same time each day.
Continuation of current TAF-containing ART for 96 weeks.
University of Alabama Birmingham
Birmingham, Alabama, United States
Stanford University
Palo Alto, California, United States
University of Colorado
Aurora, Colorado, United States
Emory
Atlanta, Georgia, United States
Percent change in lumbar spine Bone Mineral Density (BMD) at 96 weeks
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
Time frame: Baseline and 96 weeks
Percentage change in lumbar spine BMD at 48 weeks
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
Time frame: Baseline and 48 weeks
Percentage change in total hip BMD at 48 weeks
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
Time frame: Baseline, 48 weeks
Percentage change in total hip BMD at 96 weeks
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
Time frame: Baseline, 96 weeks
Change in CTX (a bone resorption marker)
Compare the changes in CTX from entry to 12, 48, and 96 weeks
Time frame: Baseline, 12 weeks, 48 weeks, and 96 weeks
Change in P1NP (a bone deposition marker)
Compare the changes in P1NP from entry to 12, 48, and 96 weeks
Time frame: Baseline, 12 weeks, 48 weeks, and 96 weeks
Change in urine β2-microglobulin (renal tubular marker)
Compare the changes in urine β2-microglobulin from entry to 48 weeks and 96 weeks.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Northwestern
Chicago, Illinois, United States
Johns Hopkins
Baltimore, Maryland, United States
Columbia
New York, New York, United States
Penn
Philadelphia, Pennsylvania, United States
Dallas VA Medical Center
Dallas, Texas, United States
UT Houston
Houston, Texas, United States
Time frame: Baseline, 48 weeks, and 96 weeks
Change in urine RBP (renal tubular marker)
Compare the changes in RBP from entry to 48 weeks and 96 weeks.
Time frame: Baseline, 48 weeks, and 96 weeks
Change in urine protein
Compare the changes in protein from entry to 48 weeks and 96 weeks.
Time frame: Baseline, 48 weeks, and 96 weeks
Change in urine albumin
Compare the changes in urine albumin from entry to 48 weeks and 96 weeks.
Time frame: Baseline, 48 weeks, and 96 weeks
Change in fractional excretion in phosphate
Compare the changes in fractional excretion of phosphate from entry to 48 weeks and 96 weeks.
Time frame: Baseline, 48 weeks, and 96 weeks
Percentage change in total lean mass
Compare the percentage change from entry to 48 weeks and 96 weeks in total lean mass (as measured by whole body DXA)
Time frame: Baseline, 48 weeks, and 96 weeks
Percentage change in trunk fat
Compare the percentage change from entry to 48 weeks and 96 weeks in trunk fat (as measured by whole body DXA)
Time frame: Baseline, 48 weeks, and 96 weeks
Percentage change in limb fat
Compare the percentage change from entry to 48 weeks and 96 weeks in limb fat (as measured by DXA)
Time frame: Baseline, 48 weeks, and 96 weeks
Maintenance of HIV RNA level
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
Time frame: 48 weeks and 96 weeks
Grade 3 or 4 adverse events
Compare rates of grade 3 or 4 adverse events experienced by participants through 96 weeks
Time frame: 96 weeks
Treatment discontinuation of study medication due to adverse effect
Compare treatment discontinuation of study medication due to adverse effect experienced by participants through 96 weeks
Time frame: 96 weeks
Change in fasting lipids
Compare changes in fasting lipids (total cholesterol, LDL, HDL, and triglycerides) at entry, 48 weeks, and 96 weeks
Time frame: Entry, 48 weeks, and 96 weeks