Demographics and Baseline Disease Characteristics in the Randomized Cohort: ITT-E Population
| Parameter . | Randomized Cohort (n = 272) . |
|---|---|
| Sex: female | 72 (26) |
| Age, y, median (range) | 48 (18–73) |
| <35 | 61 (22) |
| 35–49 | 101 (37) |
| ≥50 | 110 (40) |
| Race | |
| White | 185 (68) |
| Black or African American | 60 (22) |
| American Indian or Alaska Native | 7 (3) |
| Asian | 2 (<1) |
| Native Hawaiian or other Pacific Islander | 1 (<1) |
| Other racesa | 17 (6) |
| CD4+ T-cell count, cells/mm3, median (range) | 100 (0–1160) |
| <20 | 72 (26) |
| 20 to <50 | 25 (9) |
| 50 to <100 | 39 (14) |
| 100 to <200 | 63 (23) |
| ≥200 | 73 (27) |
| CD4+/CD8+ ratio, mean (SD) | 0.20 (0.24) |
| HIV-1 RNA, log10 copies/mL, median (range) | 4.66 (1.59–6.91) |
| <1000 | 31 (11) |
| 1000 to <10 000 | 44 (16) |
| 10 000 to 100 000 | 117 (43) |
| ≥100 000 | 80 (29) |
| History of AIDSb | 231 (85) |
| No. of fully active available ARVs in initial OBT | |
| 0c | 16 (6) |
| 1 | 142 (52) |
| 2 | 114 (42) |
| Biomarkers, mean (SD) | |
| Soluble CD14, µg/Ld | 2502.5 (1034.6) |
| Soluble CD163, µg/Le | 545.2 (212.5) |
| D-dimer, mg/L FEUf | 0.487 (0.379) |
| Parameter . | Randomized Cohort (n = 272) . |
|---|---|
| Sex: female | 72 (26) |
| Age, y, median (range) | 48 (18–73) |
| <35 | 61 (22) |
| 35–49 | 101 (37) |
| ≥50 | 110 (40) |
| Race | |
| White | 185 (68) |
| Black or African American | 60 (22) |
| American Indian or Alaska Native | 7 (3) |
| Asian | 2 (<1) |
| Native Hawaiian or other Pacific Islander | 1 (<1) |
| Other racesa | 17 (6) |
| CD4+ T-cell count, cells/mm3, median (range) | 100 (0–1160) |
| <20 | 72 (26) |
| 20 to <50 | 25 (9) |
| 50 to <100 | 39 (14) |
| 100 to <200 | 63 (23) |
| ≥200 | 73 (27) |
| CD4+/CD8+ ratio, mean (SD) | 0.20 (0.24) |
| HIV-1 RNA, log10 copies/mL, median (range) | 4.66 (1.59–6.91) |
| <1000 | 31 (11) |
| 1000 to <10 000 | 44 (16) |
| 10 000 to 100 000 | 117 (43) |
| ≥100 000 | 80 (29) |
| History of AIDSb | 231 (85) |
| No. of fully active available ARVs in initial OBT | |
| 0c | 16 (6) |
| 1 | 142 (52) |
| 2 | 114 (42) |
| Biomarkers, mean (SD) | |
| Soluble CD14, µg/Ld | 2502.5 (1034.6) |
| Soluble CD163, µg/Le | 545.2 (212.5) |
| D-dimer, mg/L FEUf | 0.487 (0.379) |
Data are presented as No. (%) unless noted otherwise.
Abbreviations: ARV, antiretroviral; FEU, fibrinogen-equivalent units; ITT-E, intention to treat exposed; OBT, optimized background therapy.
aIncludes mixed race (n = 14), Hispanic (n = 2), and North African (n = 1).
bDetermined by nadir CD4+ T-cell count <200 cells/mm3 or report of AIDS on disease history case report form.
cIncludes participants who discontinued the study during the double-blind period before starting OBT, those who had ≥1 fully active ARV at screening but no fully active ARVs in their initial OBT, and those who had no fully active ARVs at screening and were assigned to the randomized cohort in error.
dn = 258.
en = 256.
fn = 259.
Demographics and Baseline Disease Characteristics in the Randomized Cohort: ITT-E Population
| Parameter . | Randomized Cohort (n = 272) . |
|---|---|
| Sex: female | 72 (26) |
| Age, y, median (range) | 48 (18–73) |
| <35 | 61 (22) |
| 35–49 | 101 (37) |
| ≥50 | 110 (40) |
| Race | |
| White | 185 (68) |
| Black or African American | 60 (22) |
| American Indian or Alaska Native | 7 (3) |
| Asian | 2 (<1) |
| Native Hawaiian or other Pacific Islander | 1 (<1) |
| Other racesa | 17 (6) |
| CD4+ T-cell count, cells/mm3, median (range) | 100 (0–1160) |
| <20 | 72 (26) |
| 20 to <50 | 25 (9) |
| 50 to <100 | 39 (14) |
| 100 to <200 | 63 (23) |
| ≥200 | 73 (27) |
| CD4+/CD8+ ratio, mean (SD) | 0.20 (0.24) |
| HIV-1 RNA, log10 copies/mL, median (range) | 4.66 (1.59–6.91) |
| <1000 | 31 (11) |
| 1000 to <10 000 | 44 (16) |
| 10 000 to 100 000 | 117 (43) |
| ≥100 000 | 80 (29) |
| History of AIDSb | 231 (85) |
| No. of fully active available ARVs in initial OBT | |
| 0c | 16 (6) |
| 1 | 142 (52) |
| 2 | 114 (42) |
| Biomarkers, mean (SD) | |
| Soluble CD14, µg/Ld | 2502.5 (1034.6) |
| Soluble CD163, µg/Le | 545.2 (212.5) |
| D-dimer, mg/L FEUf | 0.487 (0.379) |
| Parameter . | Randomized Cohort (n = 272) . |
|---|---|
| Sex: female | 72 (26) |
| Age, y, median (range) | 48 (18–73) |
| <35 | 61 (22) |
| 35–49 | 101 (37) |
| ≥50 | 110 (40) |
| Race | |
| White | 185 (68) |
| Black or African American | 60 (22) |
| American Indian or Alaska Native | 7 (3) |
| Asian | 2 (<1) |
| Native Hawaiian or other Pacific Islander | 1 (<1) |
| Other racesa | 17 (6) |
| CD4+ T-cell count, cells/mm3, median (range) | 100 (0–1160) |
| <20 | 72 (26) |
| 20 to <50 | 25 (9) |
| 50 to <100 | 39 (14) |
| 100 to <200 | 63 (23) |
| ≥200 | 73 (27) |
| CD4+/CD8+ ratio, mean (SD) | 0.20 (0.24) |
| HIV-1 RNA, log10 copies/mL, median (range) | 4.66 (1.59–6.91) |
| <1000 | 31 (11) |
| 1000 to <10 000 | 44 (16) |
| 10 000 to 100 000 | 117 (43) |
| ≥100 000 | 80 (29) |
| History of AIDSb | 231 (85) |
| No. of fully active available ARVs in initial OBT | |
| 0c | 16 (6) |
| 1 | 142 (52) |
| 2 | 114 (42) |
| Biomarkers, mean (SD) | |
| Soluble CD14, µg/Ld | 2502.5 (1034.6) |
| Soluble CD163, µg/Le | 545.2 (212.5) |
| D-dimer, mg/L FEUf | 0.487 (0.379) |
Data are presented as No. (%) unless noted otherwise.
Abbreviations: ARV, antiretroviral; FEU, fibrinogen-equivalent units; ITT-E, intention to treat exposed; OBT, optimized background therapy.
aIncludes mixed race (n = 14), Hispanic (n = 2), and North African (n = 1).
bDetermined by nadir CD4+ T-cell count <200 cells/mm3 or report of AIDS on disease history case report form.
cIncludes participants who discontinued the study during the double-blind period before starting OBT, those who had ≥1 fully active ARV at screening but no fully active ARVs in their initial OBT, and those who had no fully active ARVs at screening and were assigned to the randomized cohort in error.
dn = 258.
en = 256.
fn = 259.
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