Table 2. Randomized clinical trials of early versus deferred initiation of antiretroviral therapy during treatment for opportunistic infections.
Study (year), country |
Opportunistic infection | Details | Main results | IRIS events (%) | Ref. | |
---|---|---|---|---|---|---|
Early
arm |
Deferred
arm |
|||||
Zolopa (2009), Multi-country |
Pneumocystis jirovecii pneumonia (63%) Serious bacterial infections (12%) Cryptococcal meningitis (12%) Miscellaneous (13%) |
ART started within 14 days (median 12 days) vs ART after completing OI treatment (median 45 days) |
Early ART reduced risk of AIDS progression/death (OR:0.51; 95% CI: 0.27–0.94) |
5.7 | 8.5 | [128] |
Abdool Karim et al. (2010), South Africa |
Smear-positive pulmonary TB | ART started during frst 3 months of TB treatment vs after completion of TB treatment CD4 count 0–500 cells/μl |
Mortality reduced in early arm (HR: 0.44) |
12.4 | 3.8 | [19] |
Blanc et al. (2010), Cambodia |
Smear-positive pulmonary or extrapulmonary TB |
ART started 2 weeks after starting TB treatment vs 2 months CD4 counts <200 cells/μl |
Mortality higher in 2-month arm Adjusted HR: 1.52 |
33 | 15 | [18] |
Torok et al. (2009), Vietnam |
Tuberculous meningitis | Immediate ART at start of TB treatment vs after 2 months |
No signifcant difference in mortality but more adverse events in immediate arm |
Not assessed | [129] | |
Makadzange et al. (2010), Zimbabwe |
Cryptococcal meningitis | ART started within 72 h of diagnosis vs after 10 weeks Patients treated with fuconazole |
3-year cumulative mortality 88% in early arm vs 54% in delayed arm (p < 0.006) Adjusted HR: 2.85 |
Not assessed | [121] |
ART: Antiretroviral therapy; HR: Hazard ratio; IRIS: Immune reconstitution infammatory syndrome; OI: Opportunistic infection; OR: Odds ratio.