Table 1. Characteristics of the Participants at Randomization.*.
| Characteristic | Co-trimoxazole Prophylaxis Continued (N = 376) | Co-trimoxazole Prophylaxis Stopped (N = 382) |
|---|---|---|
| Female sex — no. (%) | 195 (52) | 203 (53) |
| Age — yr | ||
| Median | 7.5 | 8.3 |
| Interquartile range | 4.6 to 11.1 | 4.5 to 11.0 |
| Duration of ART — yr | ||
| Median | 2.1 | 2.1 |
| Interquartile range | 1.8 to 2.3 | 1.8 to 2.3 |
| Current ART regimen — no. (%)† | ||
| 3TC-ABC-NVP | 158 (42) | 139 (36) |
| 3TC-ABC-EFV | 90 (24) | 111 (29) |
| ZDV-3TC-ABC | 125 (33) | 126 (33) |
| Other first-line regimen | 1 (<1) | 4 (1) |
| LPV/r-containing second-line regimen | 2 (1) | 2 (1) |
| ART monitoring strategy — no. (%)‡ | ||
| Laboratory and clinical monitoring | 185 (49) | 189 (49) |
| Clinically driven monitoring | 191 (51) | 193 (51) |
| CD4 T cells — % | ||
| Before ART§ | ||
| Median | 13 | 12 |
| Interquartile range | 8 to 18 | 8 to 18 |
| Current | ||
| Median | 33 | 32 |
| Interquartile range | 26 to 39 | 26 to 39 |
| Current absolute CD4 T-cell count — cells/mm3 | ||
| 3–4 yr of age | ||
| Median | 1493 | 1512 |
| Interquartile range | 1011 to 1904 | 1099 to 1931 |
| 5–7 yr of age | ||
| Median | 1043 | 1091 |
| Interquartile range | 691 to 1432 | 709 to 1367 |
| 8–11 yr of age | ||
| Median | 710 | 695 |
| Interquartile range | 516 to 957 | 482 to 985 |
| ≥12 yr of age | ||
| Median | 567 | 562 |
| Interquartile range | 402 to 749 | 410 to 757 |
| Weight-for-age z score | ||
| Before ART§ | ||
| Median | −2.2 | −2.2 |
| Interquartile range | −3.2 to −1.3 | −3.3 to −1.3 |
| Current | ||
| Median | −1.3 | −1.3 |
| Interquartile range | −1.9 to −0.6 | −1.9 to −0.7 |
3TC denotes lamivudine, ABC abacavir, ART antiretroviral therapy, EFV efavirenz, LPV/r ritonavir-boosted lopinavir, NVP nevirapine, and ZDV zidovudine.
During randomization for ART within the overarching Antiretroviral Research for Watoto (ARROW) trial, ART was initiated with 3TC–ABC and a nonnucleoside reverse transcriptase inhibitor (NNRTI; either efavirenz or nevirapine) in one third of the participants and with ZDV–3TC–ABC and an NNRTI in two thirds. After 36 weeks, half the latter group discontinued ZDV and the other half discontinued the NNRTI (induction-maintenance strategy). NNRTIs were provided by local ministries of health. The regimen containing ritonavir-boosted lopinavir is a second-line therapy; other regimens listed are first-line therapies.
During randomization for the monitoring strategy within the overarching ARROW trial, participants were assigned to laboratory and clinical monitoring or to clinically driven monitoring alone. All the participants underwent CD4 T-cell, hematologic, and biochemical measurements every 12 weeks. All the results were returned for participants assigned to laboratory and clinical monitoring, but results were only returned for those assigned to clinically driven monitoring if they were requested for clinical reasons or if they indicated a grade 4 toxic event.
Measurements before the receipt of ART were conducted at the time of enrollment in the overarching ARROW trial.