Table 1. Baseline sample characteristics for study population, complete cases and comparing trial to non-trial participants restricted to complete cases.
| Study Population | Complete Cases | Non-Trial Participants | Trial Participants | p value* | |||||
| N = 738 | % | N = 496 | % | N = 327 | % | N = 169 | % | ||
| Demographic and Behavioral Characteristics | |||||||||
| Age (years) | |||||||||
| <40 | 429 | 58.1 | 273 | 55 | 183 | 56 | 93 | 53.3 | 0.6 |
| Gender/sexual preference | |||||||||
| MSM1/Bisexual men | 252 | 34.2 | 175 | 35.3 | 101 | 30.9 | 74 | 43.8 | 0.02 |
| Heterosexual men | 260 | 35.2 | 165 | 33.2 | 114 | 34.9 | 51 | 30.2 | |
| Heterosexual women | 226 | 30.6 | 156 | 31.5 | 112 | 34.2 | 44 | 26.0 | |
| Race | |||||||||
| Black | 455 | 61.7 | 298 | 60.1 | 211 | 64.5 | 87 | 51.5 | 0.005 |
| Non Black2 | 283 | 38.3 | 198 | 39.9 | 116 | 35.5 | 82 | 48.5 | |
| Access to Care Characteristics | |||||||||
| Insurance Status | |||||||||
| Public3 | 191 | 26.3 | 126 | 25.9 | 103 | 31.8 | 23 | 14.1 | 0.001 |
| None | 276 | 38.1 | 168 | 34.6 | 96 | 29.7 | 72 | 44.2 | |
| Private/Other | 258 | 35.6 | 192 | 39.5 | 124 | 38.4 | 68 | 41.7 | |
| Distance to ID4 clinic (miles) | |||||||||
| <50 | 182 | 24.7 | 130 | 26.3 | 77 | 23.6 | 53 | 31.4 | 0.06 |
| >50 | 527 | 71.3 | 365 | 73.7 | 249 | 76.4 | 116 | 68.6 | |
| Clinical Characteristics | |||||||||
| CD4 cells/uL | |||||||||
| ≤200 | 321 | 56.6 | 257 | 57.6 | 151 | 54.1 | 106 | 63.4 | 0.1 |
| >200–350 | 107 | 18.9 | 81 | 18.2 | 53 | 19.0 | 28 | 16.8 | |
| >350 | 139 | 24.5 | 108 | 24.2 | 75 | 26.9 | 33 | 19.8 | |
| Mean HIV RNA (log10) (sd) | 4.7 | (1.0) | 4.9 | (1.0) | 4.7 | (1.0) | 4.8 | (1.0) | 0.6 |
| Diagnosis to treatment (months) | |||||||||
| ≤3 | 250 | 38.9 | 168 | 37.4 | 116 | 37.2 | 52 | 38.0 | 0.9 |
| >3 | 393 | 61.1 | 281 | 62.6 | 196 | 62.8 | 85 | 62.0 | |
| Treatment Characteristics | |||||||||
| HAART Initiation Year | |||||||||
| 1996-99 | 266 | 36.0 | 161 | 32.5 | 124 | 37.9 | 37 | 21.9 | 0.001 |
| 2000-06 | 472 | 64.0 | 335 | 67.5 | 203 | 62.1 | 132 | 78.1 | |
| HAART category5 | |||||||||
| 2 or 3 NRTI plus PI/r or 2 PI | 128 | 17.4 | 99 | 20.0 | 39 | 11.9 | 60 | 35.5 | 0.001 |
| 2 or 3 NRTI plus NNRTI | 288 | 39.0 | 192 | 38.7 | 132 | 40.4 | 60 | 35.5 | |
| 2 or 3 NRTI plus PI (unboosted) | 218 | 29.5 | 134 | 27.0 | 116 | 35.4 | 18 | 10.7 | |
| NNRTI/PI +/− 2 NRTI | 55 | 7.5 | 40 | 8.1 | 20 | 6.1 | 20 | 11.8 | |
| 3 NRTI | 49 | 6.6 | 31 | 6.3 | 20 | 6.1 | 11 | 6.5 | |
| Other Laboratory Parameters | |||||||||
| ANC6 (109/L) | |||||||||
| Normal | 348 | 47.2 | 268 | 62.2 | 173 | 65.3 | 95 | 57.2 | 0.09 |
| Abnormal | 221 | 30.0 | 163 | 37.8 | 92 | 34.7 | 71 | 42.8 | |
| Hemoglobin (g/dL) | |||||||||
| Normal | 258 | 34.9 | 195 | 41.1 | 116 | 43.6 | 79 | 47.6 | 0.4 |
| Abnormal | 311 | 42.1 | 237 | 54.9 | 150 | 56.4 | 87 | 52.4 | |
| Creatinine (mg/dL) | |||||||||
| Normal | 685 | 93.1 | 462 | 93.2 | 298 | 91.1 | 164 | 97 | 0.01 |
| Abnormal | 51 | 6.9 | 34 | 6.8 | 29 | 8.9 | 5 | 3.0 | |
| 7ALT U/L | |||||||||
| Normal | 451 | 61.1 | 338 | 81.1 | 204 | 81.3 | 134 | 80.7 | 0.9 |
| Abnormal | 100 | 13.6 | 79 | 18.9 | 47 | 18.7 | 32 | 19.3 | |
*
p value comparing trial to non trial participants restricted to complete cases.
1
MSM = Men who have sex with Men;
2
Non Black includes Caucasian, Hispanic and Other race.
3
Public insurance = Medicaid/Medicare;
4
ID = University of North Carolina Infectious Disease.
5
HAART Category; NRTI – Nucleoside Reverse Transcriptase Inhibitor; PI/r – Protease Inhibitor/Ritonavir; NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor.
6
ANC = Absolute Neutrophil Count.
7
ALT = Alanine amino transferase.