Table 1.
Characteristics of Participants who Completed at Least One Study Product Infusion
| Characteristics | Overall (N=18) | Placebo (N=5) | VRC01 (N=13) |
|---|---|---|---|
|
At Randomization | |||
| Age, years | |||
| Median (range) | 29 (21 – 50) | 25 (23-48) | 32 (21-50) |
| Risk Group, n (%) | |||
| Men who have Sex with Men | 18 (100) | 5 (100) | 13 (100) |
| Weight, kilograms | |||
| Median (range) | 68 (53 – 85) | 62 (54 – 67) | 70 (53 – 85) |
| HIV-1 Subtype, n (%) | |||
| CRF01_AE | 12 (66) | 4 (80) | 8 (61) |
| B | 4 (22) | 1 (20) | 3 (23) |
| CRF01_AE and B co-infection | 1 (6) | 0 (0) | 1 (8) |
| CRF01_AE/B/C recombinant | 1 (6) | 0 (0) | 1 (8) |
| CD4+ T-cell Count, cells per μL | |||
| Median (range) | 717 (402 – 1032) | 562 (431-735) | 769 (402-1032) |
| CD4/CD8 Ratio | |||
| Median (range) | 1⋅1 (0⋅6 – 1⋅8) | 0⋅9 (0⋅7-1⋅8) | 1⋅1 (0⋅6-1⋅6) |
| Duration from ART Initiation, years | |||
| Median (range) | 3⋅0 (2⋅2 – 6⋅6) | 2⋅7 (2⋅3-3⋅8) | 3⋅1 (2⋅3-6⋅6) |
| Duration of Viral Suppression, years | |||
| Median (range) | 2⋅5 (1⋅8 – 6⋅4) | 2⋅6 (1⋅8 – 3⋅6) | 2⋅4 (1⋅8 – 6⋅4) |
| ART Regimen, n (%) | |||
| Tenofovir-emtricitabine-efavirenz | 16 (88) | 5 (100) | 11 (84) |
| Tenofovir-emtricitabine-raltegravir | 1 (6) | 0 (0) | 1 (8) |
| Tenofovir-emtricitabine-rilpivirine | 1 (6) | 0 (0) | 1 (8) |
| At ART Initiation | |||
| Fiebig stage*, n (%) | |||
| I (RNA+, p24−) | 1 (6) | 0 (0) | 1 (8) |
| II (p24+, IgM−) | 10 (55) | 3 (60) | 7 (54) |
| III (IgM+, WB−) | 7 (39) | 2 (40) | 5 (38) |
| HIV-1 RNA, log10copies per mL | |||
| Median (range) | 5⋅9 (4⋅4 – 7⋅1) | 6⋅0 (5⋅5 – 7⋅1) | 5⋅8 (4⋅4 – 7⋅1) |
| CD4+ T-cell Count, cells per μL | |||
| Median (range) | 303 (124 – 702) | 286 (207 – 303) | 388 (124 – 702) |
| CD4/CD8 Ratio | |||
| Median (range) | 0⋅7 (0⋅2 – 1⋅8) | 0⋅8 (0⋅;6 – 1⋅5) | 0⋅6 (0⋅2 – 1⋅8) |
*
Fiebig staging was performed on the day of enrollment into RV254; participants initiated ART at median 0 (range 0-4) days after enrollment.