Table 1.
Participant Baseline Characteristics
| Cohort 1 | Cohort 2 | |||||||
|---|---|---|---|---|---|---|---|---|
| Characteristica | Total (N = 4907) | Male (N = 3034) | Female (N = 1873) | Total (N = 1396) | LMP ≤12 Months With Measurable AMH (N = 469) | LMP ≤12 Months With Undetectable AMH (N = 215) | LMP >12 Months With Undetectable AMH (N = 712) | |
| Demographics and behavioral | ||||||||
| Age, years | Median (Q1, Q3) | 50 (45, 54) | 50 (45, 54) | 49 (44, 55) | 49 (45, 55) | 44 (41, 46) | 48 (45, 51) | 55 (51, 59) |
| Enrollment regionb | High Income | 2350 (48%) | 1802 (59%) | 548 (29%) | 343 (25%) | 96 (20%) | 55 (26%) | 192 (27%) |
| Latin America and Caribbean | 944 (19%) | 602 (20%) | 342 (18%) | 281 (20%) | 77 (16%) | 44 (20%) | 160 (22%) | |
| Southeast/East Asia | 412 (8%) | 158 (5%) | 254 (14%) | 206 (15%) | 104 (22%) | 35 (16%) | 67 (9%) | |
| South Asia | 242 (5%) | 179 (6%) | 63 (3%) | 55 (4%) | 30 (6%) | 10 (5%) | 15 (2%) | |
| Sub-Saharan Africa | 959 (20%) | 293 (10%) | 666 (36%) | 511 (37%) | 162 (35%) | 71 (33%) | 278 (39%) | |
| Racec | Black or African American | 2350 (48%) | 1144 (38%) | 1206 (64%) | 894 (64%) | 259 (55%) | 132 (61%) | 503 (71%) |
| White | 1533 (31%) | 1287 (42%) | 246 (13%) | 164 (12%) | 57 (12%) | 19 (9%) | 88 (12%) | |
| Asian | 687 (14%) | 368 (12%) | 319 (17%) | 262 (19%) | 135 (29%) | 45 (21%) | 82 (12%) | |
| Other | 337 (7%) | 235 (8%) | 102 (5%) | 76 (5%) | 18 (4%) | 19 (9%) | 39 (5%) | |
| Smoking status | Current | 1093 (22%) | 787 (26%) | 306 (16%) | 190 (14%) | 45 (10%) | 27 (13%) | 118 (17%) |
| Former | 1145 (23%) | 877 (29%) | 268 (14%) | 198 (14%) | 55 (12%) | 31 (14%) | 112 (16%) | |
| Never | 2668 (54%) | 1370 (45%) | 1298 (69%) | 1008 (72%) | 369 (79%) | 157 (73%) | 482 (68%) | |
| Substance used | Current | 83 (2%) | 67 (2%) | 16 (1%) | 11 (1%) | 3 (1%) | 2 (1%) | 6 (1%) |
| Former | 1343 (27%) | 1056 (35%) | 287 (15%) | 182 (13%) | 34 (7%) | 32 (15%) | 116 (16%) | |
| Never | 3479 (71%) | 1910 (63%) | 1569 (84%) | 1203 (86%) | 432 (92%) | 181 (84%) | 590 (83%) | |
| Cardiovascular and metabolic | ||||||||
| Hypertension | 1716 (35%) | 984 (32%) | 732 (39%) | 556 (40%) | 131 (28%) | 84 (39%) | 341 (48%) | |
| Body mass index, kg/m² | Median (Q1, Q3) | 26.0 (23.0, 29.8) | 25.4 (22.7, 28.6) | 27.3 (23.5, 32.2) | 27.0 (23.4, 31.4) | 26.4 (22.6, 31.1) | 28.1 (24.4, 32.6) | 27.2 (23.7, 31.4) |
| <18.5 | 174 (4%) | 111 (4%) | 63 (3%) | 49 (4%) | 19 (4%) | 8 (4%) | 22 (3%) | |
| 18.5–24.9 | 1924 (39%) | 1319 (43%) | 605 (32%) | 469 (34%) | 172 (37%) | 57 (27%) | 240 (34%) | |
| 25–29.9 | 1649 (34%) | 1085 (36%) | 564 (30%) | 435 (31%) | 142 (30%) | 70 (33%) | 223 (31%) | |
| 30+ | 1159 (24%) | 519 (17%) | 640 (34%) | 443 (32%) | 136 (29%) | 80 (37%) | 227 (32%) | |
| Waist circumference,e cm | Normal | 3080 (63%) | 2407 (80%) | 673 (36%) | 516 (37%) | 211 (45%) | 75 (35%) | 230 (33%) |
| High | 1773 (37%) | 593 (20%) | 1180 (64%) | 871 (63%) | 256 (55%) | 138 (65%) | 477 (67%) | |
| Low-density lipoprotein cholesterol, mg/dL | Median (Q1, Q3) | 107 (87, 129) | 106 (86, 127) | 109 (89, 131) | 109 (90, 131) | 102 (86, 123) | 108 (89, 132) | 114 (94, 134) |
| Estimated glomerular filtration rate by chronic kidney disease -EPI, mL/min per 1.73 mm² | Median (Q1, Q3) | 98 (82, 111) | 95 (80, 107) | 104 (88, 118) | 104 (89, 118) | 109 (96, 124) | 105 (88, 118) | 100 (85, 113) |
| HGB, g/dL | Median (Q1, Q3) | 14.0 (13.0, 15.1) | 14.7 (13.9, 15.6) | 12.9 (12.0, 13.7) | 12.9 (12.0, 13.7) | 12.6 (11.3,13.5) | 12.8 (11.9,13.6) | 13.1 (12.3,13.8) |
| HIV disease characteristics | ||||||||
| Time since HIV diagnosis, years | <5 | 493 (10%) | 320 (11%) | 173 (9%) | 131 (9%) | 44 (9%) | 22 (10%) | 65 (9%) |
| 5–10 | 1369 (28%) | 871 (29%) | 498 (27%) | 367 (26%) | 129 (28%) | 57 (27%) | 181 (25%) | |
| >10 | 3044 (62%) | 1843 (61%) | 1201 (64%) | 897 (64%) | 296 (63%) | 136 (63%) | 465 (65%) | |
| Nadir CD4 count, cells/mm³ | <200 | 2372 (48%) | 1455 (48%) | 917 (49%) | 692 (50%) | 207 (44%) | 116 (54%) | 369 (52%) |
| 200–349 | 1283 (26%) | 808 (27%) | 475 (25%) | 356 (26%) | 128 (27%) | 53 (25%) | 175 (25%) | |
| 350–499 | 605 (12%) | 388 (13%) | 217 (12%) | 163 (12%) | 68 (14%) | 18 (8%) | 77 (11%) | |
| 500+ | 506 (10%) | 289 (10%) | 217 (12%) | 153 (11%) | 57 (12%) | 22 (10%) | 74 (10%) | |
| Unknown | 141 (3%) | 94 (3%) | 47 (3%) | 32 (2%) | 9 (2%) | 6 (3%) | 17 (2%) | |
| History of AIDS-defining event | 1187 (24%) | 735 (24%) | 452 (24%) | 361 (26%) | 108 (23%) | 58 (27%) | 195 (27%) | |
| Total ART use, years | <5 | 1093 (22%) | 652 (21%) | 441 (24%) | 328 (23%) | 126 (27%) | 56 (26%) | 146 (21%) |
| 5–10 | 1444 (29%) | 921 (30%) | 523 (28%) | 389 (28%) | 138 (29%) | 59 (27%) | 192 (27%) | |
| 10+ | 2370 (48%) | 1461 (48%) | 909 (49%) | 679 (49%) | 205 (44%) | 100 (47%) | 374 (53%) | |
| ART regimen class | NRTI + INSTI | 1225 (25%) | 923 (30%) | 302 (16%) | 206 (15%) | 51 (11%) | 32 (15%) | 123 (17%) |
| NRTI + NNRTI | 2393 (49%) | 1283 (42%) | 1110 (59%) | 857 (61%) | 307 (65%) | 126 (59%) | 424 (60%) | |
| NRTI + Protease inhibitor | 891 (18%) | 537 (18%) | 354 (19%) | 269 (19%) | 94 (20%) | 45 (21%) | 130 (18%) | |
| NRTI-sparing | 101 (2%) | 67 (2%) | 34 (2%) | 25 (2%) | 7 (1%) | 4 (2%) | 14 (2%) | |
| Other NRTI-containing | 296 (6%) | 223 (7%) | 73 (4%) | 39 (3%) | 10 (2%) | 8 (4%) | 21 (3%) | |
| CD4 count,f cells/mm3 | Median (Q1, Q3) | 632 (464, 840) | 606 (433, 803) | 688 (499, 910) | 688 (497, 910) | 650 (496, 875) | 688 (483, 893) | 707 (511, 928) |
| 50–199 | 128 (3%) | 94 (3%) | 34 (2%) | 27 (2%) | 10 (2%) | 6 (3%) | 11 (2%) | |
| 200–349 | 486 (10%) | 346 (11%) | 140 (7%) | 108 (8%) | 40 (9%) | 20 (9%) | 48 (7%) | |
| 350–499 | 875 (18%) | 578 (19%) | 297 (16%) | 219 (16%) | 71 (15%) | 34 (16%) | 114 (16%) | |
| 500+ | 3418 (70%) | 2016 (66%) | 1402 (75%) | 1042 (75%) | 348 (74%) | 155 (72%) | 539 (76%) | |
| HIV-1 RNA, copies/mL | <LLQ | 3269 (87%) | 2155 (87%) | 1114 (88%) | 815 (88%) | 275 (88%) | 133 (89%) | 407 (88%) |
| LLQ < 400 | 394 (11%) | 276 (11%) | 118 (9%) | 74 (8%) | 25 (8%) | 12 (8%) | 37 (8%) | |
| 400+ | 80 (2%) | 40 (2%) | 40 (3%) | 34 (4%) | 11 (4%) | 4 (3%) | 19 (4%) | |
| Other comorbid conditions | ||||||||
| Chronic active hepatitis B virus | 127 (3%) | 97 (3%) | 30 (2%) | 21 (2%) | 8 (2%) | 4 (2%) | 9 (1%) | |
| Chronic active hepatitis C virus | 97 (2%) | 72 (2%) | 25 (1%) | 17 (1%) | 4 (1%) | 5 (2%) | 8 (1%) | |
| Inflammatory markers | ||||||||
| Soluble CD14, ng/mL | Median (Q1, Q3) | 1743 (1468, 2064) | 1690 (1432, 1998) | 1829 (1546, 2177) | 1835 (1555, 2194) | 1768 (1497, 2142) | 1821 (1507, 2209) | 1886 (1622, 2226) |
| Oxidized low-density lipoprotein cholesterol, U/L | Median (Q1,Q3) | 53 (42, 68) | 54 (43, 70) | 52 (41, 65) | 52 (41, 64) | 51 (40, 63) | 52 (40, 67) | 52 (42, 64) |
Abbreviations: AMH, anti-Müllerian hormone; ART, antiretroviral therapy; EPI, epidemiology collaboration; HGB, hemoglobin; HIV, human immunodeficiency virus; INSTI, integrase strand transfer inhibitor; LLQ, lower limit of quantitation; LMP, last menstrual period; NNRTI, nonnucleoside reverse transcriptase inhibitor; NRTI, nucleoside reverse transcriptase inhibitor.
Frequency (%) for categorical measures, and median with lower and upper quartiles (Q1, Q3) for continuous measures. All statistics are calculated for participants with data collected. Missing data include smoking status (n = 1), substance use (n = 2), body mass index (n = 1), waist circumference (n = 54), low-density lipoprotein cholesterol (n = 42), estimated glomerular filtration rate by chronic kidney disease-EPI (n = 1), HGB (n = 18), time since HIV diagnosis (n = 1), HIV-1 RNA (n = 1164), sCD14 (n = 2), and oxidized low-density lipoprotein (n = 1).
Classified according to global burden of disease regions.
“Other” race includes participants self-identifying as native or indigenous to the enrollment region, more than 1 race (with no single race noted as predominant), or of unknown race.
Substance use includes use of cocaine, methamphetamine, and intravenous drugs.
Normal waist circumference is defined as ≤102 cm for men and ≤88 cm for women.
CD4 count obtained at entry.