Table 1.
Supplemental dolutegravir arm (n=53) | Placebo arm (n=55) | Total (n=108) | |||
---|---|---|---|---|---|
Demographics | |||||
Age, years | 33 (28–38) | 37 (33–44) | 35 (31–40) | ||
Sex | |||||
Female | 19 (36%) | 19 (35%) | 38 (35%) | ||
Male | 34 (64%) | 36 (65%) | 70 (65%) | ||
Weight, kg | 56 (51–62) | 55 (51–62) | 56 (51–62) | ||
BMI, kg/m2 | 20·0 (18·7–22·3) | 20·2 (18·3–22·8) | 20·1 (18·5–22·6) | ||
HIV characteristics | |||||
HIV-1 RNA log10(log10 copies per mL) | 5·1 (4·6–5·6) | 5·2 (4·6–5·7) | 5·2 (4·6–5·7) | ||
≤100 000 copies per mL, n (%) | 21 (40%) | 21 (38%) | 42 (39%) | ||
>100 000 copies per mL, n (%) | 32 (60%) | 34 (62%) | 66 (61%) | ||
CD4 count (cells per μL) | 197 (145–260) | 183 (145–316) | 188 (145–316) | ||
≤200 | 27 (51%) | 30 (55%) | 57 (53%) | ||
>200 | 26 (49%) | 25 (45%) | 51 (47%) | ||
Baseline ART status, n (%) | |||||
ART naive | 44 (83%) | 44 (80%) | 88 (81%) | ||
First-line ART interrupted | 9 (17%) | 11 (20%) | 20 (19%) | ||
On ART <6 months before interruption | 8 (15%) | 5 (9%) | 13 (12%) | ||
On ART ≥6 months before interruption | 1 (2%) | 6 (11%) | 7 (6%) | ||
Tuberculosis characteristics | |||||
Diagnosis | |||||
Microbiological or histological (or both) | 38 (72%) | 39 (71%) | 77 (71%) | ||
Clinical or radiological (or both) | 15 (28%) | 16 (29%) | 31 (29%) | ||
Site | |||||
Pulmonary | 40 (75%) | 37 (67%) | 77 (71%) | ||
Extrapulmonary | 10 (19%) | 13 (24%) | 23 (21%) | ||
Disseminated | 3 (6%) | 5 (9%) | 8 (7%) | ||
Weeks on tuberculosis treatment at enrolment | 8·0 (7·0–8·9) | 8·0 (6·0–8·3) | 8·0 (6·6–8·6) |
Data are median (IQR) or n (%). Baseline was date of screening. ART=antiretroviral therapy.