Table 2.
Summary of data available from randomized controlled trials (RCTs) to date
| Study | Study name / acronym and registration | Country | N | Opportunistic infection(s) | Comparison | Median (IQR) CD4 counts (cells/μL) | Outcome |
|---|---|---|---|---|---|---|---|
| Zolopa et al. 2009 [29**] | ACTG A5164 NCT00055120 | USA, Puerto Rico, South Africa (multicentre) | 282 | Acute AIDS-related OIs or severe bacterial infections excluding TB (63% PCP, 12% bacterial infections, 12% cryptococcal disease, 5% toxoplasmosis, 8% other) | Early arm: started ART within 14 days of starting treatment for OI (median=12 days). Deferred ART: started ART after OI treatment completed (median=45 days). |
Early: 31 (12-54) Deferred: 28 (10-56) |
No difference in primary composite end-point. But early ART associated with low risk of progression to AIDS or death (OR=0.51, 95%CI 0.27-0.94) and no increase in adverse events or IRD |
| Abdool Karim et al. 2010 [31**] | SAPIT NCT00398996 | South Africa | 642 | Smear positive pulmonary TB and CD4 cell counts <500 cells/μL | Early: 2 ‘integrated’ arms started ART with first 3 months of TB treatment. Late: the deferred group started ART within 1 month of the end of TB treatment. |
Integrated: 150 (77-254) Sequential: 140 (69-247) |
The hazards of death in the early ‘integrated’ groups was 0.44 (95%CI, 0.25-0.79) overall, 0.54 (0.30-0.98) in those with CD4 counts ≤200 cells/μL and 0.16 (0.03-0.79) in those with a CD4 count >200 cells/μL |
| Blanc et al. 2010. [33**] | CAMELIA NCT00226434 | Cambodia | 661 | Smear positive pulmonary or extrapulmonary TB and CD4 cell counts <200 cells/μL | Early arm: within 2 weeks Late arm: after 2 months |
Early: 25 (11-56) Late: 25 (10-55) |
35% lower risk of mortality in the early arm |
| Torok et al. 2009 [30**] | NCT00433719 | Vietnam | 253 | Tuberculous meningitis | Immediate ART versus ART deferred for 2 months | Early: 39 (18-116) Late: 43.5 (16-84) |
Hazards of death in immediate arm were 1.12 (95%CI 0.81-1.55; p=0.52) |
| Makadzange et al. 2010 [32**] | NCT00830856 | Zimbabwe | 54 | Cryptococcal meningitis | Early arm: within 72 hours of diagnosis. Late arm: after 10 weeks of treatment with fluconazole |
Early: 27 (17-69) Late: 51.5 (25-69.5) |
The hazards of death in the early arm was 2.85 (95%CI, 1.1-7.23) |