Table 1.
Baseline characteristics
| Raltegravir group (n=258) | NRTI group (n=254) | |
|---|---|---|
| Age (years) | 39 (34–44) | 38 (33–43) |
|
| ||
| Men | 124 (48%) | 128 (50%) |
|
| ||
| Race | ||
| White, non-Hispanic | 0 | 1 (<1%) |
| Black, non-Hispanic | 164 (64%) | 162 (64%) |
| Hispanic | 11 (4%) | 9 (4%) |
| Asian or Pacific Islander | 83 (32%) | 82 (32%) |
|
| ||
| Body-mass index (kg/m2) | 23 (20–27) | 22 (19–25) |
|
| ||
| Plasma HIV-1 RNA | ||
| Log10 copies per mL | 4·6 (0·8) | 4·5 (0·9) |
| ≥100 000 copies per mL at screening | 84 (33%) | 82 (32%) |
|
| ||
| CD4 counts (cells per μL) | 178 (170) | 182 (160) |
|
| ||
| Nadir CD4 counts (cell per μL) | 122 (136) | 113 (96) |
|
| ||
| Time on first-line regimen (years) | 4·1 (2·2–6·3) | 4·0 (2·2–6·0) |
|
| ||
| Past AIDS-defining event | 70 (27%) | 80 (31%) |
|
| ||
| HIV-1 subtype* | ||
| A1 | 21/244 (9%) | 26/246 (11%) |
| B | 10/244 (4%) | 8/246 (3%) |
| C | 201/244 (82%) | 195/246 (79%) |
| Other | 12/244 (5%) | 17/246 (7%) |
|
| ||
| NRTI selected for use at study entry† | ||
| Emtricitabine and tenofovir‡ | – | 173 (68%) |
| Lamivudine and zidovudine | – | 49 (19%) |
| Lamivudine and abacavir | – | 21 (8%) |
| Emtricitabine, tenofovir‡, and zidovudine | – | 8 (3%) |
| Lamivudine, zidovudine, and abacavir | – | 2 (1%) |
|
| ||
| Local resistance test available before study entry | 10 (4%) | 9 (4%) |
|
| ||
| Genotypic mutations at baseline§ | 244 (95%) | 246 (97%)† |
| At least one NRTI mutation | 231/244 (95%) | 238/246 (97%) |
| Met184Val/Ile | 217/244 (89%) | 221/246 (90%) |
| Lys65Arg | 56/244 (23%) | 51/246 (21%) |
| ≥1 TAM | 113/244 (46%) | 124/246 (50%) |
| ≥3 TAMs | 59/244 (24%) | 60/246 (24%) |
| Gln151Met | 3/244 (1%) | 7/246 (3%) |
| 69 insertion/deletion | 0 | 4/246 (2%) |
| Complex resistance (Lys65Arg, ≥3 TAMs, Gln151Met, 69 insertion/deletion) | 115/244 (47%) | 119/246 (48%) |
| NRTI genotypic sensitivity score† | ||
| <1 | – | 117/245 (48%) |
| ≥1 | – | 128/245 (52%) |
|
| ||
| ≥1 NNRTI mutation | 238/244 (98%) | 238/246 (97%) |
Data are median (IQR), n (%), mean (SD), or n/N (%). NRTI=nucleoside or nucleotide reverse transcriptase inhibitor. NNRTI=non-nucleoside/nucleotide reverse transcriptase inhibitor. TAM=thymidine analogue mutation.
*
HIV subtype for 490 participants with HIV resistance tests at study entry.
†
One participant did not start treatment in NRTI arm.
‡
Tenofovir disoproxil fumarate.
§
Codon mixtures are counted as mutant.