Table 2.
Clinical Characteristics of Study Population by Plasma Viral Load Assay LLD and Cervicovaginal Inflammation (ISV) (N person-visits=959).a
| ISVc | PVL | CV-VL | Antiretroviral therapy | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| PVL | CV- VL |
N | 0 | 1 | Median (range) | Median (range) | None | Non- HAART |
HAART | |
| PVL LLD = 4000 | ||||||||||
| <4000 | <80 | 9 | 2 | 7 | N/A | N/A | 5 (55%) | 4 (44%) | 0 | |
| <4000 | ≥80 | 1 | 0 | 1 | N/A | 1,300 | 1 (100%) | 0 | 0 | |
| P-value**: | 1.00 | |||||||||
| ≥4000 | <80 | 90b | 14 | 76 | 47000 (4,200–2,100,000) | N/A | 25 (28%) | 64 (72%) | 0 | |
| ≥4000 | ≥80 | 111 | 17 | 94 | 59000 (4,600–4,900,000) | 3100 (80–660,000) | 27 (24%) | 83 (75%) | 1 (1%) | |
| P-value**: | 1.00 | |||||||||
| Total | 211 | 58 (28%) | 151 (72%) | 1 (0.5%) | ||||||
| PVL LLD = 400 | ||||||||||
| <400 | <80 | 23 | 7 | 16 | N/A | N/A | 3 (13%) | 4 (17%) | 16 (70%) | |
| <400 | ≥80 | 1 | 1 | 0 | N/A | 5,400 | 1 (100%) | 0 | 0 | |
| P-value**: | 0.33 | |||||||||
| ≥400 | <80 | 45 | 11 | 34 | 8600 (500–290,000) | N/A | 13 (29%) | 11 (24%) | 21 (47%) | |
| ≥400 | ≥80 | 32 | 3 | 29 | 24500 (590–1,900,000) | 1900 (83–290,000) | 15 (47%) | 8 (25%) | 9 (28%) | |
| P-value**: | 0.14 | |||||||||
| Total | 101 | 32 (32%) | 23 (23%) | 46 (45%) | ||||||
| PVL LLD = 80 | ||||||||||
| <80 | <80 | 164 | 50 | 114 | N/A | N/A | 20 (12%) | 16 (10%) | 128(78%) | |
| <80 | ≥80 | 13 | 5 | 8 | N/A | 1100 (100–6,300) | 5 (38%) | 2 (15%) | 6(47%) | |
| P-value**: | 0.55 | |||||||||
| ≥80 | <80 | 301* | 87 | 213 | 3100 (82–590,000) | N/A | 115 (38%) | 65 (22%) | 121(40%) | |
| ≥80 | ≥80 | 169 | 28 | 141 | 13000 (81–4,600,000) | 1100 (82–270,000) | 81 (48%) | 34 (20%) | 54(32%) | |
| P-value**: | 0.003 | |||||||||
| Total | 647 | 221 (34%) | 117 (18%) | 309(48%) | ||||||
| All visits | ||||||||||
| UD | <80 | 196 | 59 | 137 | N/A | N/A | 28 (14%) | 24 (12%) | 144 (74%) | |
| UD | ≥80 | 15 | 6 | 9 | N/A | 1,300 (100–6,300) | 7 (47%) | 2 (13%) | 6 (40%) | |
| D | <80 | 436* | 112 | 323 | 5,650 (82–2,100,000) | N/A | 153 (35%) | 140 (32%) | 142 (33%) | |
| D | ≥80 | 312 | 48 | 264 | 29,000 (81–4,900,000) | 14,000 (80–660,000) | 123 (39%) | 125 (40%) | 64 (21%) | |
| Total | 959 | 225 | 733 | 311 (32%) | 291 (30%) | 356 (38%) | ||||
PVL=plasma viral load; CV-VL=cervicovaginal viral load; HAART=highly active antiretroviral therapy; LLD=lower limit of detection; UD=undetectable; D=detectable.
HIV viral load is unknown for 17 person-visits which are excluded from this table.
Antiretroviral therapy is unknown for one subject.
ISV=inflammation summary variable: value is 1 if any of the following is present at person-visit; inflammation-associated cellular changes, cervical ectopy, exudate, friability, lesions, vaginal pH >5.5, intermediate BV (Nugent) score, consistent BV score, or trichomoniasis, 0 if none is present.
ISV is unknown for one visit for PVL LLD=80, PVL >=80, CV-VL<80 and for all visits PVL = D, CV-VL<80
Fisher's exact tests are used to test associations between ISP and CV-VL for different levels of PVL (detectable, undetectable) in LLD categories.