Table 6

Randomized controlled studies of the timing of starting antiretroviral therapy (ART) during tuberculosis (TB) treatment
Study Study population Methods Results
N Location TB Median CD4+ cells/mm3 (IQR) Timing of ART in weeks ‘earlier’ vs ‘later’ Primary endpoint Follow-up in months Primary endpoint ‘earlier’ vs ‘later’a Primary endpoint in CD4 <50 cells/μlb TB immune reconstitution
SAPIT [48] (first analysis) 429 South Africa Smear-positive pulmonary TB 150 (77 to 254) <12 vs after end TB treatment Death 12.1 5.4 vs 12.1 P = 0.003c Not reported 12.4% vs 3.8% P <0.001
SAPIT [96] (second analysis) 429 South Africa Smear-positive pulmonary TB 150 (77 to 254) Within 4 vs 8 to 12 AIDS or death 17.7 6.9 vs 7.8 P = 0.73 8.5 vs 26.3bP = 0.06 20.1% vs 7.7% P <0.001
CAMELIA [95] 660 Cambodia Smear-positive TB 25 (11 to 56) 2 vs 8 Death 25 18% vs 27%, P = 0.006 Not reportedd 33.1% vs 13.7% P <0.001
STRIDE [55] 809 Multicontinente Confirmed or presumed pulmonary or extrapulmonary TB 77 (36 to 145) 2 vs 8 to 12 AIDS or death 12 12.9% vs 16.1% P = 0.45 15.5% vs 26.6% P = 0.02 11% vs 5% P = 0.02
TB Meningitis [97] 253 Vietnam TB meningitis 39 (18 to 116) ≤1 vs 8 Deathf 12 59.8% vs 55.6% P = 0.50 63.3% vs 65.1% P = 0.84 Not reported
TIME Trial [98] 156 Thailand Confirmed or presumed pulmonary or extrapulmonary TB 43 (37 to 106) 4 vs 12 Death 96 weeks 7.6% vs 6.5% P >0.99 8.7% vs 13.1% P = 0.725 8.86 vs 5.02 P = 0.069

Footnotes:

aPresented either as cumulative incidence of primary endpoint in early vs. later arm (%) or as events per 100 person-years.

bPrespecified analysis.

cSignificant difference in mortality observed in patients with either CD4 counts <200 cells/μl or 200 to 500 cells/μl.

dLower CD4 was not associated with an increased risk for the primary endpoint.

eNorth America, South America, Asia, Africa.

fPrimary endpoint was all cause mortality at 9 months.

Lawn et al.

Lawn et al. BMC Medicine 2013 11:253   doi:10.1186/1741-7015-11-253

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