Table 2.
Baseline characteristics of ISS T-002 subjects pre- and post-protocol amendment and ISS OBS T-002 subjects
| ISS T-002 pre-amendment | ISS T-002 post-amendment | ISS OBS T-002 | OBS vs pre-amendment T-002 | OBS vs post-amendment T-002 | |
|---|---|---|---|---|---|
| ( n = 87) | ( n = 81) | ( n = 79) | p-value b | p-value b | |
| Age | |||||
| Mean ± s.d.a | 41 ± 7 | 42 ± 7 | 42 ± 6 | 0.2963 | 0.8043 |
| Range | 26-54 | 23-55 | 24-55 | ||
| Gender | |||||
| Male | 78% | 86% | 75% | 0.5977 | 0.0604 |
| Female | 22% | 14% | 25% | ||
| CD4 + nadir (cells/μl) | |||||
| Mean ± s.d. | 352 ± 114 | 251 ± 131 | 219 ± 140 | <0.0001 | 0.1131 |
| Range | 252-846 | 14-585 | 2-612 | ||
| CD4 + (cells/μl) | |||||
| Mean ± s.d. | 693 ± 210 | 585 ± 215 | 657 ± 271 | 0.4018 | 0.0668 |
| Range | 425-1490 | 144-1250 | 208-1527 | ||
| CD4 + (%) | |||||
| Mean ± s.d. | 34 ± 7 | 32 ± 8 | 31 ± 8 | 0.0033 | 0.2596 |
| Range | 19-53 | 14-61 | 12-52 | ||
| Years from diagnosis of HIV | |||||
| Mean ± s.d. | 9 ± 6 | 9 ± 7 | 11 ± 7 | 0.1583 | 0.3703 |
| Range | 1-23 | 1-25 | 1-24 | ||
| Years from HAART initiation | |||||
| Mean ± s.d. | 6 ± 4 | 7 ± 5 | 6 ± 5 | 0.2552 | 0.9073 |
| Range | 0-19 | 0-19 | 0-19 | ||
| Current HAART regimen | |||||
| NNRTI-based or NRTI | 75% | 56% | 62% | 0.0784 | 0.3434 |
| PI-based | 25% | 44% | 38% |
n indicates the number of individuals; aStandard deviation; b t-test was applied for continuous variables, Chi-square test was applied for categorical variables.