Table 4.
CD4+ T-Cell Counts at the 12-Month Follow-up Visit
| Characteristic | Parent Trial | Total DVR (n = 103) |
All Participants (N = 151) |
||
|---|---|---|---|---|---|
| The Ring Study Placebo (n = 48) |
The Ring Study DVR (n = 80) |
DREAM DVR (n = 23) |
|||
| Participants with month 12 follow-up after enrollment | 41 (85.4) | 70 (87.5) | 22 (95.7) | 92 (89.3) | 133 (88.1) |
| All participants, irrespective of ARV treatment | |||||
| ȃNo. | 40 | 70 | 22 | 92 | 132 |
| ȃCD4+ T-cell count <200 cells/μL | 2 (5.0) | 0 | 0 | 0 | 2 (1.5) |
| ȃCD4+ T-cell count 200–500 cells/μL | 20 (50.0) | 29 (41.4) | 2 (9.1) | 31 (33.7) | 51 (38.6) |
| ȃCD4+ T-cell count >500 cells/μL | 18 (45.0) | 41 (58.6) | 20 (90.9) | 61 (66.3) | 79 (59.8) |
| ȃMedian CD4+ T-cell count, cells/μL (range) | 486 (199–1219) |
563 (251–1378) |
755.5 (357–1137) |
605.5 (251–1378) |
570 (199–1378) |
| Participants not on ARV treatmenta | |||||
| ȃNo. | 25 | 37 | 2 | 39 | 64 |
| ȃCD4+ T-cell count <200 cells/μL | 1 (4.0) | 0 | 0 | 0 | 1 (1.6) |
| ȃCD4+ T-cell count 200–500 cells/μL | 15 (60.0) | 19 (51.4) | 1 (50.0) | 20 (51.3) | 35 (54.7) |
| ȃCD4+ T-cell count >500 cells/μL | 9 (36.0) | 18 (48.6) | 1 (50.0) | 19 (48.7) | 28 (43.8) |
| ȃMedian CD4+ T-cell count, cells/μL (range) | 477.0 (199–821) |
497.0 (251–1378) |
530 (368–692) |
497.0 (251–1378) |
493.5 (199–1378) |
Data are presented as No. (%) unless otherwise indicated. Percentages are expressed as the percentage of the total number of participants enrolled in each treatment group.
Abbreviations: ARV, antiretroviral; DREAM, dapivirine ring extended access and monitoring; DVR, dapivirine vaginal ring.
As per participant report.