Table 1.
Baseline characteristics
| Dolutegravir | Standard of care | Total | ||
|---|---|---|---|---|
| Participants | 42 | 43 | 85 | |
| Country | ||||
| South Africa | 8 (19%) | 12 (28%) | 20 (24%) | |
| Uganda | 22 (52%) | 21 (49%) | 43 (51%) | |
| Zimbabwe | 12 (29%) | 10 (23%) | 22 (26%) | |
| ODYSSEY A or ODYSSEY B | ||||
| ODYSSEY A (starting first-line ART) | 35 (83%) | 37 (86%) | 72 (85%) | |
| ODYSSEY B (switching to second-line ART) | 7 (17%) | 6 (14%) | 13 (15%) | |
| Sex | ||||
| Female | 26 (62%) | 18 (42%) | 44 (52%) | |
| Male | 16 (38%) | 25 (58%) | 41 (48%) | |
| Age at enrolment, years | ||||
| Median | 1·3 (0·5 to 2·0; 0·3 to 5·9) | 1·5 (0·6 to 2·1; 0·1 to 4·5) | 1·4 (0·6 to 2·0; 0·1 to 5·9) | |
| <6 months | 11 (26%) | 8 (19%) | 19 (22%) | |
| 6 months to <1 year | 5 (12%) | 8 (19%) | 13 (15%) | |
| 1 year to <3 years | 22 (52%) | 22 (51%) | 44 (52%) | |
| 3 years to <6 years | 4 (10%) | 5 (12%) | 9 (11%) | |
| Weight, kg | ||||
| Median | 8·1 (5·6 to 10·0; 3·8 to 13·0) | 8·2 (5·2 to 10·3; 3·4 to 13·4) | 8·1 (5·4 to 10·0; 3·4 to 13·4) | |
| 3 kg to <6 kg | 11 (26%) | 12 (28%) | 23 (27%) | |
| 6 kg to <10 kg | 20 (48%) | 20 (47%) | 40 (47%) | |
| 10 kg to <14 kg | 11 (26%) | 11 (26%) | 22 (26%) | |
| Weight-for-age z score | ||||
| Median | −2·1 (−3·4 to −1·3; −5·1 to 0·3) | −1·8 (−3·7 to −0·8; −5·7 to 1·4) | −1·9 (−3·4 to −1·1; −5·7 to 1·4) | |
| <–3 | 14 (33%) | 13 (30%) | 27 (32%) | |
| −3 to <–2 | 7 (17%) | 6 (14%) | 13 (15%) | |
| −2 to <0 | 18 (43%) | 21 (49%) | 39 (46%) | |
| ≥0 | 3 (7%) | 3 (7%) | 6 (7%) | |
| BMI-for-age z score | ||||
| Median | −1·1 (−1·9 to 0·2; −3·6 to 1·9) | −0·7 (−2·2 to 0·3; −5·7 to 3·1) | −0·8 (−2·0 to 0·2; −5·7 to 3·1) | |
| <–3 | 3 (7%) | 6 (14%) | 9 (11%) | |
| −3 to <–2 | 6 (14%) | 6 (14%) | 12 (14%) | |
| −2 to <0 | 20 (48%) | 14 (33%) | 34 (40%) | |
| ≥0 | 13 (31%) | 17 (40%) | 30 (35%) | |
| CD4 percentage* | ||||
| Median | 24 (17 to 35) | 23 (14 to 30) | 23 (16 to 31) | |
| <15% | 7 (17%) | 11 (28%) | 18 (22%) | |
| 15% to <30% | 22 (54%) | 18 (45%) | 40 (49%) | |
| ≥30% | 12 (29%) | 11 (28%) | 23 (28%) | |
| Missing | 1 | 3 | 4 | |
| CD4, cells per mm3* | ||||
| Median | 1639 (1026 to 2327) | 1221 (633 to 1870) | 1391 (863 to 2060) | |
| Viral load, copies per mL* | ||||
| <10 000 | 4 (10%) | 7 (18%) | 11 (14%) | |
| 10 000 to <100 000 | 13 (31%) | 5 (13%) | 18 (23%) | |
| 100 000 to <500 000 | 12 (29%) | 15 (39%) | 27 (34%) | |
| ≥500 000 | 13 (31%) | 11 (29%) | 24 (30%) | |
| Missing† | 0 | 5 | 5 | |
| Log10 viral load, copies per mL* | ||||
| Median | 5·2 (4·4 to 5·8) | 5·4 (4·8 to 5·9) | 5·3 (4·6 to 5·9) | |
| History of WHO HIV/AIDS staging‡ | ||||
| Stage 1–2 | 31 (74%) | 25 (58%) | 56 (66%) | |
| Stage 3 | 6 (14%) | 8 (19%) | 14 (16%) | |
| Stage 4 | 5 (12%) | 10 (23%) | 15 (18%) | |
| Prevention of vertical transmission ART exposure | ||||
| No | 19 (46%) | 23 (59%) | 42 (53%) | |
| Yes | 22 (54%) | 16 (41%) | 38 (48%) | |
| Unknown | 1 | 4 | 5 | |
Data are n (%), median (IQR; range), or median (IQR). Percentages are for the non-missing proportion. ART=antiretroviral therapy.
*
Mean of measurement at screening and randomisation if both were available.
†
In each of the five participants with missing baseline viral load measurements, the sites were unable to draw a sufficient volume of blood for testing.
‡
Worst known stage prior to enrolment.