sCD14 (soluble cluster of differentiation 14) is a biomarker of gut microbial translocation and monocyte/macrophage activation.

The outcome measures are changes in log10 transformed sCD14 from baseline to week 15/16 (week 15/16 - baseline) Levels measured at pre-entry and entry were averaged for baseline, levels measured at week 15 and week 16 were averaged for week 15/16.

As-treated population limited to participants who had baseline and week 15/16 measurements, completed study treatment with no more than 34 cumulative days of treatment interruption, did not use prohibited medications, did not have a confirmed virologic failure at or prior to week 16 (see protocol 6.2.3).

sCD14 (soluble cluster of differentiation 14) is a biomarker of gut microbial translocation and monocyte/macrophage activation.

The outcome measures are changes in log10 transformed sCD14 from week 15/16 to week 20 (week 20 - week 15/16).

Levels measured at week 15 and week 16 were averaged for week 15/16.

As-treated population limited to participants who had baseline and week 15/16 measurements, completed study treatment with no more than 34 cumulative days of treatment interruption, did not use prohibited medications, did not have a confirmed virologic failure at or prior to week 16 (see protocol 6.2.3).

sCD163 (soluble CD 163) is a marker of macrophage activation and arterial inflammation.

Change in log10 transformed sCD163 from Week 0 to week 15 (week 15 - week 0), and from week 15 to week 20 (week 20 - week 15).

As-treated population limited to participants who had baseline and week 15 measurements, completed study treatment with no more than 34 cumulative days of treatment interruption, did not use prohibited medications, did not have a confirmed virologic failure at or prior to week 16 (see protocol 6.2.3).

sCD26 (soluble cluster of differentiation 26) is an enzyme that metabolizes DPP-4 (dipeptidyl peptidase-4), an enzyme that is inhibited by sitagliptin.

Change in log10 transformed sCD26 from Week 0 to week 15 (week 15 - week 0), and from week 15 to week 20 (week 20 - week 15).

As-treated population limited to participants who had baseline and week 15 measurements, completed study treatment with no more than 34 cumulative days of treatment interruption, did not use prohibited medications, did not have a confirmed virologic failure at or prior to week 16 (see protocol 6.2.3).

IL-6 (Interleukin-6) is a biomarker of systemic inflammation. Change in log10 transformed IL-6 from Week 0 to week 15 (week 15 - week 0), and from week 15 to week 20 (week 20 - week 15).

As-treated population limited to participants who had baseline and week 15 measurements, completed study treatment with no more than 34 cumulative days of treatment interruption, did not use prohibited medications, did not have a confirmed virologic failure at or prior to week 16 (see protocol 6.2.3).

hsCRP (high-sensitivity C-reactive protein) is a biomarker of inflammation. Change in log10 transformed hsCRP from Week 0 to week 15 (week 15 - week 0), and from week 15 to week 20 (week 20 - week 15).

As-treated population limited to participants who had baseline and week 15 measurements, completed study treatment with no more than 34 cumulative days of treatment interruption, did not use prohibited medications, did not have a confirmed virologic failure at or prior to week 16 (see protocol 6.2.3).

sTNF-r1 (soluble tumour necrosis alpha receptor 1) is a biomarker of inflammation.

Change in log10 transformed sTNF-r1 from Week 0 to week 15 (week 15 - week 0), and from week 15 to week 20 (week 20 - week 15).

As-treated population limited to participants who had baseline and week 15 measurements, completed study treatment with no more than 34 cumulative days of treatment interruption, did not use prohibited medications, did not have a confirmed virologic failure at or prior to week 16 (see protocol 6.2.3).

sTNF-r2 (soluble tumour necrosis alpha receptor 2) is a biomarker of inflammation.

Change in log10 transformed sTNF-r2 from Week 0 to week 15 (week 15 - week 0), and from week 15 to week 20 (week 20 - week 15).

As-treated population limited to participants who had baseline and week 15 measurements, completed study treatment with no more than 34 cumulative days of treatment interruption, did not use prohibited medications, did not have a confirmed virologic failure at or prior to week 16 (see protocol 6.2.3).

IP-10 (also known as CXCL10) is a biomarker implicated in cardiovascular disease.

Change in log10 transformed IP-10 from Week 0 to week 15 (week 15 - week 0), and from week 15 to week 20 (week 20 - week 15).

As-treated population limited to participants who had baseline and week 15 measurements, completed study treatment with no more than 34 cumulative days of treatment interruption, did not use prohibited medications, did not have a confirmed virologic failure at or prior to week 16 (see protocol 6.2.3).

CD4+/CD8+ T-cell ratio change from week 0 to week 15 (week 15 - week 0). Note that CD4 and CD8 were not evaluated at week 20 in this study.

As-treated population limited to participants who had baseline and week 15 measurements, completed study treatment with no more than 34 cumulative days of treatment interruption, did not use prohibited medications, did not have a confirmed virologic failure at or prior to week 16 (see protocol 6.2.3).

Level of CD4+ T-cell activation was determined by measuring the percentage of cells that expressed both the activation marker CD38+ and Human leukocyte antigen (HLA)-DR+.

The endpoint is measuring the change from week 0 to week 15 (week 15 - week 0) and change from week 15 to week 20 (week 20 - week 15).

Data for cellular markers are not available as of December 2017. These data are based on immunology assays which were tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 1 month after the primary complete date. Please note that these secondary outcomes were not included in the primary analyses. There are many outcomes in this study and the immunology lab had to give priority to the assays planned to be included in the primary manuscript. Results will be entered once the data is complete and analyzed.

As-treated population limited to participants who had baseline and week 15/16 measurements, completed study treatment with no more than 34 cumulative days of treatment interruption, did not use prohibited medications, did not have a confirmed virologic failure at or prior to week 16 (see protocol 6.2.3).

Level of CD8+ T-cell activation was determined by measuring the percentage of cells that expressed both the activation marker CD38+ and Human leukocyte antigen (HLA)-DR+.

The endpoint is measuring the change from week 0 to week 15 (week 15 - week 0) and change from week 15 to week 20 (week 20 - week 15).

Data for cellular markers are not available as of December 2017. These data are based on immunology assays which were tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 1 month after the primary complete date. Please note that these secondary outcomes were not included in the primary analyses. There are many outcomes in this study and the immunology lab had to give priority to the assays planned to be included in the primary manuscript. Results will be entered once the data is complete and analyzed.

As-treated population limited to participants who had baseline and week 15/16 measurements, completed study treatment with no more than 34 cumulative days of treatment interruption, did not use prohibited medications, did not have a confirmed virologic failure at or prior to week 16 (see protocol 6.2.3).

CD14+/CD16- is the percentage of cells that expressed CD14 and low CD16 in total monocytes (also known as classical monocytes).

This endpoint is measuring the change from week 0 to week 15 (week 15 - week 0) and change from week 15 to week 20 (week 20 - week 15).

Data for cellular markers are not available as of November 2017. The study team prioritized completion of the soluble markers (including the primary outcome measure), which are reported herein, over the completion of the cellular markers. Results will be entered once the data is complete and analyzed.

As-treated population limited to participants who had baseline and week 15/16 measurements, completed study treatment with no more than 34 cumulative days of treatment interruption, did not use prohibited medications, did not have a confirmed virologic failure at or prior to week 16 (see protocol 6.2.3).

%CD14+/CD16+ is the percentage of cells that expressed both CD14 and CD16 in total monocytes (also known as intermediate monocytes).

This endpoint is measuring the change from week 0 to week 15 (week 15 - week 0) and change from week 15 to week 20 (week 20 - week 15).

Data for cellular markers are not available as of December 2017. These data are based on immunology assays which were tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 1 month after the primary complete date. Please note that these secondary outcomes were not included in the primary analyses. There are many outcomes in this study and the immunology lab had to give priority to the assays planned to be included in the primary manuscript. Results will be entered once the data is complete and analyzed.

As-treated population limited to participants who had baseline and week 15/16 measurements, completed study treatment with no more than 34 cumulative days of treatment interruption, did not use prohibited medications, did not have a confirmed virologic failure at or prior to week 16 (see protocol 6.2.3).

%CD14dim/CD16++ is the percentage of cells that expressed low levels of CD14dim and high levels of CD16++ in total monocytes (also known as non-classical monocytes).

This endpoint is measuring the change from week 0 to week 15 (week 15 - week 0) and change from week 15 to week 20 (week 20 - week 15).

Data for cellular markers are not available as of December 2017. These data are based on immunology assays which were tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 1 month after the primary complete date. Please note that these secondary outcomes were not included in the primary analyses. There are many outcomes in this study and the immunology lab had to give priority to the assays planned to be included in the primary manuscript. Results will be entered once the data is complete and analyzed.

As-treated population limited to participants who had baseline and week 15/16 measurements, completed study treatment with no more than 34 cumulative days of treatment interruption, did not use prohibited medications, did not have a confirmed virologic failure at or prior to week 16 (see protocol 6.2.3).

The DAIDS Adverse Event Grading Table, Version 2.0, was used for grading of AEs

All enrolled participants