Table 4.
Main safety outcomes by study arm in the HPTN 035 trial
| BufferGel (n=775) | 0.5% PRO2000 Gel (n=769) | Placebo Gel (n=771) | No Gel (n=772) | Overall (n=3087) | |
|---|---|---|---|---|---|
| Participants with adverse events | |||||
| - Deaths | 2 (0.3%) | 2 (0.3%) | 1 (0.1%) | 2 (0.3%) | 7 (0.2%) |
| - Hospitalizations | 37 (5.6%) | 30 (3.9%) | 30 (3.9%) | 33 (4.3%) | 130 (4.2%) |
| - Reproductive system events | 412 (53%) | 393 (51%) | 387 (50%) | 375 (49%) | 1567 (51%) |
| - Vaginal discharge | 229 (30%) | 221 (29%) | 202 (26%) | 223 (29%) | 875 (28%) |
| - Vulvovaginal pruritus | 115 (15%) | 97 (13%) | 105 (14%) | 90 (12%) | 407 (13%) |
| - Metrorrhagia | 53 (7%) | 55 (7%)1 | 36 (5%) | 51 (7%) | 195 (6%) |
| - Cervix haemorrhage uterine | 39 (5%) | 37 (5%) | 36 (5%) | 40 (5%) | 152 (5%) |
| - Menorrhagia | 34 (4%) | 31 (4%) | 29 (4%) | 35 (5%) | 129 (4%) |
| - Adverse event categories | |||||
| - Genital infection events | 563 (73%) | 577 (75%) | 557 (72%) | 561 (73%) | 2258 (73%) |
| - Genital irritation events | 317 (41%) | 308 (40%) | 302 (39%) | 281 (36%) | 1208 (39%) |
| - Genital bleeding abnormality events | 140 (18%) | 135 (18%) | 116 (15%) | 143 (19%) | 534 (17%) |
| - Urinary tract events | 126 (16%) | 132 (17%) | 109 (14%) | 106 (14%) | 473 (15%) |
| - Genital pain events | 79 (10%) | 78 (10%) | 73 (9%) | 65 (8%) | 295 (10%) |
| - Genital lesion events | 78 (10%)2 | 63 (8%) | 53 (7%) | 70 (9%) | 264 (9%) |
| - Intermenstrual bleeding events | 56 (7%) | 63 (8%)3 | 39 (5%) | 54 (7%) | 212 (7%) |
| - Pregnancy-related events | 41 (5%) | 39 (5%) | 30 (4%) | 40 (5%) | 150 (5%) |
| - Coagulation abnormalities | 2 (0.3%) | 4 (0.5%) | 2 (0.3%) | 2 (0.3%) | 10 (0.3%) |
|
| |||||
| Systemic liver, renal and coagulation abnormalities during Phase II (/participants in Phase II) | 1/195 (0.5%) | 2/201 (1.0%) | 1/201 (0.5%) | 1/196 (0.5%) | 5/793 (0.6%) |
|
| |||||
| Pelvic Exam Findings (events per 100 person-years) | |||||
| - Deep epithelial disruption | 1.1 | 1.7 | 1.5 | 1.9 | 1.5 |
| - Abnormal vaginal discharge | 77.4 | 78.2 | 73.7 | 73.0 | 75.6 |
| - Any blood-related finding | 17.4 | 16.1 | 15.3 | 14.9 | 15.9 |
| - Blood from cervical os | 10.7 | 9.8 | 10.5 | 8.5 | 9.8 |
| - Erythema | 6.3 4 | 7.9 | 7.4 | 10.9 | 8.2 |
| - Petechia | 5.0 | 3.9 | 4.6 | 5.2 | 4.7 |
| - Blood-tinged discharge | 4.0 | 2.4 | 2.6 | 3.8 | 3.2 |
| - Blood in vagina – no identified source | 2.5 | 3.5 5 | 1.8 | 2.3 | 2.5 |
| - Ulceration | 2.6 | 1.9 | 1.9 | 3.5 | 2.5 |
|
| |||||
| Pregnancy rate (per 100 person-years) | 11.2 | 12.0 | 9.9 | 12.2 | 11.3 |
| Proportion of pregnancies resulting in live births | 70% | 68% | 71% | 68% | 69% |
1
p=0.04 vs. Placebo;
2
p=0.02 vs. Placebo;
3
p=0.01 vs. Placebo;
4
p=0.02 vs. No Gel;
5
p<0.01 vs. Placebo