| Primary | Change in CD8+ T-cell Activation From Baseline to Week 4 | Change in CD8+ T-cell activation percent co-expressing HLA-DR and CD38 from baseline to week 4, where the baseline value is the average of pre-entry and entry values. | The primary analysis is as-treated, limited to subjects who had data for both baseline and week 4, and (for the rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change antiretroviral therapy (ART) or use prohibited medications or have virologic failure during this time period. | Posted | | Median | Inter-Quartile Range | percentage HLA-DR+/CD38+ of CD8+ | | At baseline and 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Treatment With Rifaximin | Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks. | | OG001 | Arm B: No Study Treatment | No study treatment for 4 weeks |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0000.00(-1.70 to 1.00)
- OG0010.64(0.11 to 1.48)
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| Null hypothesis: There is no difference between the two arms in the change in T-cell activation from baseline to week 4 | Wilcoxon (Mann-Whitney) | | 0.028 | not adjusted for multiple comparisons | | | | | | | | | | | | | Superiority or Other | | |
|
| Secondary | Change in D-dimer From Baseline to Week 4 | Change in D-dimer from baseline to week 4, where baseline value is the average of pre-entry and entry. D-dimer is a fibrin degradation product (FDP), a small protein fragment present in the blood after a blood clot is degraded by fibrinolysis. | This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period. | Posted | | Median | Inter-Quartile Range | log10 ng/mL | | At baseline and 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Treatment With Rifaximin | Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks. | | OG001 | Arm B: No Study Treatment | No study treatment for 4 weeks |
| |
| Secondary | Change in IL-6 From Baseline to Week 4 | Change in Interleukin (IL)-6 from baseline to week 4, where baseline value is the average of pre-entry and entry | This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period. | Posted | | Median | Inter-Quartile Range | log10 pg/mL | | At baseline and 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Treatment With Rifaximin | Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks. | | OG001 | Arm B: No Study Treatment | No study treatment for 4 weeks |
| |
| Secondary | Change in LPS From Baseline to Week 4 | Change in Lipopolysaccharide (LPS) from baseline to week 4, where baseline value is the average of pre-entry and entry | This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period. | Posted | | Median | Inter-Quartile Range | log10 pg/mL | | At baseline and 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Treatment With Rifaximin | Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks. | | OG001 | Arm B: No Study Treatment | No study treatment for 4 weeks |
| |
| Secondary | Change in hsCRP From Baseline to Week 4 | Change in High Sensitivity C-reactive Protein (Hs-CRP) from baseline to week 4, where baseline value is the average of pre-entry and entry | This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period. | Posted | | Median | Inter-Quartile Range | log10 ng/mL | | At baseline and 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Treatment With Rifaximin | Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks. | | OG001 | Arm B: No Study Treatment | No study treatment for 4 weeks |
| |
| Secondary | Change in sCD14 From Baseline to Week 4 | Change in soluble CD14 (sCD14) from baseline to week 4, where baseline value is the average of pre-entry and entry | This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period. | Posted | | Median | Inter-Quartile Range | log10 ng/mL | | At baseline and 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Treatment With Rifaximin | Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks. | | OG001 | Arm B: No Study Treatment | No study treatment for 4 weeks |
| |
| Secondary | Change in Peripheral B7hi CD4+ T-cell From Baseline to Week 4 | Change in gut-homing percent B7hi+ of CD4+ from baseline to week 4, where baseline value is the average of pre-entry and entry | This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period. | Posted | | Median | Inter-Quartile Range | percentage B7hi+ of CD4+ | | At baseline and 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Treatment With Rifaximin | Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks. | | OG001 | Arm B: No Study Treatment | No study treatment for 4 weeks |
| |
| Secondary | Change in %CD38+ of CD4+ From Baseline to Week 4 | Change in advanced flow percent CD38+ of CD4+ from baseline to week 4, where baseline value is the average of pre-entry and entry | This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period. | Posted | | Median | Inter-Quartile Range | percentage CD38+ of CD4+ | | At baseline and 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Treatment With Rifaximin | Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks. | | OG001 | Arm B: No Study Treatment | No study treatment for 4 weeks |
| |
| Secondary | Change in %CD38+ of CD8+ From Baseline to Week 4 | Change in advanced flow percent CD38+ of CD8+ from baseline to week 4, where baseline value is the average of pre-entry and entry | This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period. | Posted | | Median | Inter-Quartile Range | percentage CD38+ of CD8+ | | At baseline and 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Treatment With Rifaximin | Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks. | | OG001 | Arm B: No Study Treatment | No study treatment for 4 weeks |
| |
| Secondary | Change in %Ki67+ of CD4+ From Baseline to Week 4 | Change in advanced flow percent Ki67+ of CD4+ from baseline to week 4, where baseline value is the average of pre-entry and entry | This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period. | Posted | | Median | Inter-Quartile Range | percentage Ki67+ of CD4+ | | At baseline and 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Treatment With Rifaximin | Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks. | | OG001 | Arm B: No Study Treatment | No study treatment for 4 weeks |
| |
| Secondary | Change in %Ki67+ of CD8+ From Baseline to Week 4 | Change in advanced flow percent Ki67+ of CD8+ from baseline to week 4, where baseline value is the average of pre-entry and entry | This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period. | Posted | | Median | Inter-Quartile Range | percentage Ki67+ of CD8+ | | At baseline and 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Treatment With Rifaximin | Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks. | | OG001 | Arm B: No Study Treatment | No study treatment for 4 weeks |
| |
| Secondary | Change in %HLA-DR+/CD38+ of CD4+ From Baseline to Week 4 | Change in CD4 activation percent co-expressing HLA-DR and CD38 from baseline to week 4, where baseline value is the average of pre-entry and entry | This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period. | Posted | | Median | Inter-Quartile Range | percentage HLA-DR+/CD38+ of CD4+ | | At baseline and 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Treatment With Rifaximin | Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks. | | OG001 | Arm B: No Study Treatment | No study treatment for 4 weeks |
| |
| Secondary | Change in CD38+ of CD8+ MFI From Baseline to Week 4 | Change in CD38+ of CD8+ MFI (Median Fluorescence Intensity) from baseline to week 4, where baseline value is the average of pre-entry and entry. MFI measures the shift in fluorescence intensity of a population of cells. MFI values are based on control to demonstrate an increase or decrease in expression of the marker. MFI in this study was automatically calculated in FlowJo. The median is the relative intensity value below which 50% of the events are found. MFI is an arbitrary unit of relative intensity. | This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period. | Posted | | Median | Inter-Quartile Range | MFI (relative intensity) | | At baseline and 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Treatment With Rifaximin | Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks. | | OG001 | Arm B: No Study Treatment | No study treatment for 4 weeks |
| |
| Secondary | Change in CD4 Count From Baseline to Week 4 | Change in total CD4 T-cell from baseline to week 4, where baseline value is the average of pre-entry and entry | This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period. | Posted | | Median | Inter-Quartile Range | cells/mm3 | | At baseline and 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Treatment With Rifaximin | Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks. | | OG001 | Arm B: No Study Treatment | No study treatment for 4 weeks |
| |
| Secondary | Change in CD8+ T-cell Activation From Week 4 to Week 8 | Change in CD8+ T-cell activation percent co-expressing HLA-DR and CD38 from week 4 to week 8 | This analysis is as-treated, limited to subjects who had data for both week 4 and week 8, and (for the rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8. | Posted | | Median | Inter-Quartile Range | percentage HLA-DR+/CD38+ of CD8+ | | At weeks 4 and 8 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Treatment With Rifaximin | Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks. | | OG001 | Arm B: No Study Treatment | No study treatment for 4 weeks |
| |
| Secondary | Change in D-dimer From Week 4 to Week 8 | D-dimer is a fibrin degradation product (FDP), a small protein fragment present in the blood after a blood clot is degraded by fibrinolysis. | This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8 | Posted | | Median | Inter-Quartile Range | log10 ng/mL | | At weeks 4 and 8 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Treatment With Rifaximin | Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks. | | OG001 | Arm B: No Study Treatment | No study treatment for 4 weeks |
| |
| Secondary | Change in IL-6 From Week 4 to Week 8 | Change in IL-6 from week 4 to week 8. | This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8 | Posted | | Median | Inter-Quartile Range | log10 pg/mL | | At weeks 4 and 8 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Treatment With Rifaximin | Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks. | | OG001 | Arm B: No Study Treatment | No study treatment for 4 weeks |
| |
| Secondary | Change in LPS From Week 4 to Week 8 | Change in LPS from week 4 to week 8. | This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8 | Posted | | Median | Inter-Quartile Range | log10 pg/mL | | At weeks 4 and 8 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Treatment With Rifaximin | Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks. | | OG001 | Arm B: No Study Treatment | No study treatment for 4 weeks |
| |
| Secondary | Change in hsCRP From Week 4 to Week 8 | Change in hsCRP from week 4 to week 8. | This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8 | Posted | | Median | Inter-Quartile Range | log10 ng/mL | | At weeks 4 and 8 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Treatment With Rifaximin | Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks. | | OG001 | Arm B: No Study Treatment | No study treatment for 4 weeks |
| |
| Secondary | Change in sCD14 From Week 4 to Week 8 | Change in soluble CD14 from week 4 to week 8 | This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8 | Posted | | Median | Inter-Quartile Range | log10 ng/mL | | At weeks 4 and 8 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Treatment With Rifaximin | Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks. | | OG001 | Arm B: No Study Treatment | No study treatment for 4 weeks |
| |
| Secondary | Change in Peripheral B7hi CD4+ T-cells From Week 4 to Week 8 | Change in gut homing percent B7hi+ of CD4+ from week 4 to week 8 | This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8 | Posted | | Median | Inter-Quartile Range | percentage B7hi+ of CD4+ | | At weeks 4 and 8 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Treatment With Rifaximin | Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks. | | OG001 | Arm B: No Study Treatment | No study treatment for 4 weeks |
| |
| Secondary | Change in %CD38+ of CD4+ From Week 4 to Week 8 | Change in advanced flow percent CD38+ of CD4+ from week 4 to week 8 | This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8 | Posted | | Median | Inter-Quartile Range | percentage CD38+ of CD4+ | | At weeks 4 and 8 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Treatment With Rifaximin | Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks. | | OG001 | Arm B: No Study Treatment | No study treatment for 4 weeks |
| |
| Secondary | Change in %CD38+ of CD8+ From Week 4 to Week 8 | Change in advanced flow percent CD38+ of CD8+ from week 4 to week 8 | This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8 | Posted | | Median | Inter-Quartile Range | percentage CD38+ of CD8+ | | At weeks 4 and 8 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Treatment With Rifaximin | Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks. | | OG001 | Arm B: No Study Treatment | No study treatment for 4 weeks |
| |
| Secondary | Change in %Ki67+ of CD4+ From Week 4 to Week 8 | Change in advanced flow percent Ki67+ of CD4+ from week 4 to week 8 | This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8 | Posted | | Median | Inter-Quartile Range | percentage Ki67+ of CD4+ | | At weeks 4 and 8 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Treatment With Rifaximin | Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks. | | OG001 | Arm B: No Study Treatment | No study treatment for 4 weeks |
| |
| Secondary | Change in %Ki67+ of CD8+ From Week 4 to Week 8 | Change in advanced flow percent Ki67+ of CD8+ from week 4 to week 8 | This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8 | Posted | | Median | Inter-Quartile Range | percentage Ki67+ of CD8+ | | At weeks 4 and 8 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Treatment With Rifaximin | Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks. | | OG001 | Arm B: No Study Treatment | No study treatment for 4 weeks |
| |
| Secondary | Change in CD4 Activation Percent From Week 4 to Week 8 | Change in CD4 activation percent co-expressing HLA-DR and CD38 from week 4 to week 8 | This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8 | Posted | | Median | Inter-Quartile Range | percentage HLA-DR+/CD38+ of CD4+ | | At weeks 4 and 8 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Treatment With Rifaximin | Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks. | | OG001 | Arm B: No Study Treatment | No study treatment for 4 weeks |
| |
| Secondary | Change in CD38+ of CD8+ MFI From Week 4 to Week 8 | Change in CD38+ of CD8+ median fluorescence intensity (MFI) from week 4 to week 8. MFI measures the shift in fluorescence intensity of a population of cells. MFI values are based on control to demonstrate an increase or decrease in expression of the marker. MFI in this study was automatically calculated in FlowJo. The median is the relative intensity value below which 50% of the events are found. MFI is an arbitrary unit of relative intensity. | This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8 | Posted | | Median | Inter-Quartile Range | MFI (relative intensity) | | At weeks 4 and 8 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Treatment With Rifaximin | Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks. | | OG001 | Arm B: No Study Treatment | No study treatment for 4 weeks |
| |
| Secondary | Change in CD4 Count From Week 4 to Week 8 | Change in total CD4 T-cell count from week 4 to week 8 | This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8 | Posted | | Median | Inter-Quartile Range | cells/mm3 | | At weeks 4 and 8 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Treatment With Rifaximin | Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks. | | OG001 | Arm B: No Study Treatment | No study treatment for 4 weeks |
| |
| Secondary | Change in CD8+ T-cell Activation From Week 4 to Week 12 | Change in CD8+ T-cell activation percent co-expressing HLA-DR and CD38 from week 4 to week 12 | This analysis is as-treated, limited to subjects who had data for both week 4 and week 12, and (for the rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12. | Posted | | Median | Inter-Quartile Range | percentage HLA-DR+/CD38+ of CD8+ | | At weeks 4 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Treatment With Rifaximin | Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks. | | OG001 | Arm B: No Study Treatment | No study treatment for 4 weeks |
| |
| Secondary | Change in D-dimer From Week 4 to Week 12 | D-dimer is a fibrin degradation product (FDP), a small protein fragment present in the blood after a blood clot is degraded by fibrinolysis. | This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12. | Posted | | Median | Inter-Quartile Range | log10 ng/mL | | At weeks 4 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Treatment With Rifaximin | Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks. | | OG001 | Arm B: No Study Treatment | No study treatment for 4 weeks |
| |
| Secondary | Change in IL-6 From Week 4 to Week 12 | Change in IL-6 from week 4 to week 12. | This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12. | Posted | | Median | Inter-Quartile Range | log10 pg/mL | | At weeks 4 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Treatment With Rifaximin | Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks. | | OG001 | Arm B: No Study Treatment | No study treatment for 4 weeks |
| |
| Secondary | Change in LPS From Week 4 to Week 12 | Change in LPS from week 4 to week 12. | This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12. | Posted | | Median | Inter-Quartile Range | log10 pg/mL | | At weeks 4 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Treatment With Rifaximin | Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks. | | OG001 | Arm B: No Study Treatment | No study treatment for 4 weeks |
| |
| Secondary | Change in hsCRP From Week 4 to Week 12 | Change in hsCRP from week 4 to week 12. | This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12. | Posted | | Median | Inter-Quartile Range | log10 ng/mL | | At weeks 4 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Treatment With Rifaximin | Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks. | | OG001 | Arm B: No Study Treatment | No study treatment for 4 weeks |
| |
| Secondary | Change in sCD14 From Week 4 to Week 12 | Change in soluble CD14 from week 4 to week 12 | This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12. | Posted | | Median | Inter-Quartile Range | log10 ng/mL | | At weeks 4 and 8 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Treatment With Rifaximin | Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks. | | OG001 | Arm B: No Study Treatment | No study treatment for 4 weeks |
| |
| Secondary | Change in Peripheral B7hi CD4+ T-cells From Week 4 to Week 12 | Change in gut homing percent B7hi+ of CD4+ from week 4 to week 12 | This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12. | Posted | | Median | Inter-Quartile Range | percentage B7hi+ of CD4+ | | At weeks 4 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Treatment With Rifaximin | Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks. | | OG001 | Arm B: No Study Treatment | No study treatment for 4 weeks |
| |
| Secondary | Change in %CD38+ of CD4+ From Week 4 to Week 12 | Change in advanced flow percent CD38+ of CD4+ from week 4 to week 12 | This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12 | Posted | | Median | Inter-Quartile Range | percentage CD38+ of CD4+ | | At weeks 4 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Treatment With Rifaximin | Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks. | | OG001 | Arm B: No Study Treatment | No study treatment for 4 weeks |
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| Secondary | Change in %CD38+ of CD8+ From Week 4 to Week 12 | Change in advanced flow percent CD38+ of CD8+ from week 4 to week 12 | This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12. | Posted | | Median | Inter-Quartile Range | percentage CD38+ of CD8+ | | At weeks 4 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Treatment With Rifaximin | Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks. | | OG001 | Arm B: No Study Treatment | No study treatment for 4 weeks |
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| Secondary | Change in %Ki67+ of CD4+ From Week 4 to Week 12 | Change in advanced flow percent Ki67+ of CD4+ from week 4 to week 12 | This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12 | Posted | | Median | Inter-Quartile Range | percentage Ki67+ of CD4+ | | At weeks 4 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Treatment With Rifaximin | Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks. | | OG001 | Arm B: No Study Treatment | No study treatment for 4 weeks |
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| Secondary | Change in %Ki67+ of CD8+ From Week 4 to Week 12 | Change in advanced flow percent Ki67+ of CD8+ from week 4 to week 12 | This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12 | Posted | | Median | Inter-Quartile Range | percentage Ki67+ of CD8+ | | At weeks 4 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Treatment With Rifaximin | Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks. | | OG001 | Arm B: No Study Treatment | No study treatment for 4 weeks |
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| Secondary | Change in CD4 Activation Percent From Week 4 to Week 12 | Change in CD4 activation percent co-expressing HLA-DR and CD38 from week 4 to week 12 | This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12. | Posted | | Median | Inter-Quartile Range | percentage HLA-DR+/CD38+ of CD4+ | | At weeks 4 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Treatment With Rifaximin | Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks. | | OG001 | Arm B: No Study Treatment | No study treatment for 4 weeks |
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| Secondary | Change in CD38+ of CD8+ MFI From Week 4 to Week 12 | Change in CD38+ of CD8+ median fluorescence intensity (MFI) from week 4 to week 12. MFI measures the shift in fluorescence intensity of a population of cells. MFI values are based on control to demonstrate an increase or decrease in expression of the marker. MFI in this study was automatically calculated in FlowJo. The median is the relative intensity value below which 50% of the events are found. MFI is an arbitrary unit of relative intensity. | This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12. | Posted | | Median | Inter-Quartile Range | MFI (relative intensity) | | At weeks 4 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Treatment With Rifaximin | Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks. | | OG001 | Arm B: No Study Treatment | No study treatment for 4 weeks |
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| Secondary | Change in CD4 Count From Week 4 to Week 12 | Change in total CD4 T-cell count from week 4 to week 12 | This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12. | Posted | | Median | Inter-Quartile Range | cells/mm3 | | At weeks 4 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Treatment With Rifaximin | Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks. | | OG001 | Arm B: No Study Treatment | No study treatment for 4 weeks |
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| Secondary | Primary Adverse Events | Primary adverse events include all SAEs, defined according to ICH guidelines and targeted protocol events (grade 2 or higher signs and symptoms, grade 2 or higher laboratory abnormality, all diagnoses identified by the ACTG criteria for clinical events, and all events that led to a change in treatment regardless of grade). | | Posted | | Number | | participants | | from study enrollment until study completion at 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Treatment With Rifaximin | Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks. | | OG001 | Arm B: No Study Treatment | No study treatment for 4 weeks |
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