Table 3.
Primary endpoint results
| On-site | No on-site | ||||||
|---|---|---|---|---|---|---|---|
| Pts | Pts with event (%) | Pts | Pts with event (%) | ICCb | OR (95% CI)c | p-valuec | |
| Primary outcomea | 2107 (99 sites) |
134 (6.4) (56 sites) |
2264 (97 sites) |
85 (3.8) (34 sites) |
0.08 | 1.7 (1.1, 2.7) | 0.03 |
| Components of primary endpoint | |||||||
| Eligibility violation | 12 (0.6) | 1 (0.04) | 12.2 (1.8, 85.2) | 0.01 | |||
| - HIV negative | 3 (0.1) | 0 (0.0) | |||||
| - Did not have 2 consecutive CD4+ cell counts >500 within 60 days prior to randomization | 1 (0.04) | 1 (0.04) | |||||
| - Prior use of antiretroviral therapy | 8 (0.4) | 0 (0.0) | |||||
| - Prior use interleukin-2 (IL-2) | 0 (0.0) | 0 (0.0) | |||||
| - Pregnant | 0 (0.0) | 0 (0.0) | |||||
| Informed consent violationd | 56 (2.7) | 41 (1.8) | 1.3 (0.6, 2.7) | 0.46 | |||
| - Prior to randomization, participant signed an incorrect or unapproved main study consent form | 13 (0.6) | 0 (0.0) | |||||
| - Baseline stored specimens were collected prior the participant signing the IRB/EC-approved main study consent form | 8 (0.4) | 17 (0.8) | 0.7 (0.2, 1.9) | 0.44 | |||
| - The signature page of the most recently signed main study consent form is not on file | 38 (1.8) | 29 (1.3) | 1.0 (0.4, 2.3) | >0.99 | |||
| - The signature on the most recently signed main study consent form not signed by the participant or legal representative | 2 (0.1) | 3 (0.1) | 0.7 (0.2, 3.3) | 0.68 | |||
| Use of ART drug for initial therapy not permitted by protocol | 17 (0.8) | 13 (0.6) | 1.4 (0.6, 3.4) | 0.47 | |||
| START primary endpoint reported > 6 months from occurence | 23 (1.1) | 16 (0.7) | 1.5 (0.7, 3.0) | 0.27 | |||
| - Confirmed START primary endpoints | 10 (0.5) | 11 (0.5) | 0.9 (0.4, 2.3) | 0.88 | |||
| START serious event reported > 6 months from occurrenced | 34 (1.6) | 19 (0.8) | 2.0 (1.1, 3.7) | 0.02 | |||
| - Grade 4 events | 12 (0.6) | 6 (0.3) | 2.1 (0.9, 5.3) | 0.10 | |||
| - Unscheduled hospitalizations | 25 (1.2) | 17 (0.8) | 1.7 (0.8, 3.3) | 0.14 | |||
| Data alteration/fraud | 0 (0.0) | 0 (0.0) | -- | -- | |||
a
Participants could have multiple outcomes identified. In total, there were 158 primary outcomes for 134 participants in the on-site group and 102 primary outcomes for 85 participants in the no on-site group
b
Intraclass correlation coefficient for discrete outcomes using the method reported by Snijders and Bosker
c
Logistic regression fixed effects hierarchical model comparing the on-site group to the no on-site group
d
Participants could have more than one type of violation for this monitoring outcome
IRB = Institutional review board
EC = Ethics committee
ART = Antiretroviral therapy