| IMMEDIATE initiation of cART compared to DEFERRED initiation of cART for HIV-positive, treatment-naive children aged 24 to 59 months (2 to 5 years old) | ||||||
|---|---|---|---|---|---|---|
| Patient or population: HIV-positive, treatment-naive children aged one to 12 years old Settings: Thailand and Cambodia Intervention: IMMEDIATE initiation of cART Comparison: DEFERRED initiation of cART | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| DEFERRED initiation of cART | IMMEDIATE initiation of cART | |||||
| Death | 0 per 1000 | 0 per 1000 (0 to 0) | RR 3 (0.12 to 73.06) | 343 (2 studies) | ⊕○○○ very low1,2,3 |
|
|
CDC Category C disease (number of children) Follow-up: 144 weeks |
12 per 1000 | 18 per 1000 (3 to 105) | RR 1.5 (0.25 to 8.85) | 343 (2 studies) | ⊕○○○ very low1,2,4 |
|
|
CDC Category B disease (numbers of children) Peto Odds Ratio |
189 per 1000 | 141 per 1000 (83 to 225) | OR 0.7 (0.39 to 1.24) | 343 (2 studies) | ⊕○○○ very low1,2,4,5 |
|
| Proportion of children on ART with HIV-RNA <50 copies/ml (Copy) | 815 per 1000 | 783 per 1000 (685 to 889) | RR 0.96 (0.84 to 1.09) | 238 (2 studies) | ⊕⊕○ ○ low1,2,4 |
|
| Weight gain per year in kg | The mean weight gain per year in kg in the intervention groups was 0.1 higher (0.16 lower to 0.36 higher) | 300 (1 study) | ⊕⊕○ ○ low1,2,6,7 |
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| Height gain per year in cm | The mean height gain per year in cm in the intervention groups was 0.5 higher (0.2 to 0.8 higher) | 300 (1 study) | ⊕⊕○ ○ low1,2,6,7 |
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| Standardized score on Beery VMI at 144 weeks | The mean standardized score on Beery VMI at 144 weeks in the intervention groups was 1.4 lower (4.7 lower to 1.9 higher) | 272 (1 study) | ⊕⊕○ ○ low1,2,6,7 |
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The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio; OR: Odds ratio;
|
Patient or population: HIV-positive, treatment-naive children aged 24 to 59 months (2 to 5 years old) Settings: Thailand and Cambodia Intervention: IMMEDIATE initiation of cART Comparison: DEFERRED initiation of cART |
|||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments |
| Assumed risk | Corresponding risk | ||||
| DEFERRED initiation of cART |
As the trials were open-label neither participants nor caregivers were blinded. However outcome assessors were blinded in the PREDICT trial. Attrition was low in both trials. Information on the randomisation procedure was lacking in Ananworanich 2008. However, given that this trial is relatively small, we judged the overall risk of bias to be low for the two trials together.
The age group included in the trials ranged from one year to 12 years old and did not focus on the specific population focus of this review: ages 24 to 59 months.
The confidence interval is very large and the event rate very low. There was only one death.
The event rate was very low and the overall sample size is also small.
The trials reported conflicting results and there was substantial unexplained heterogeneity.
The results are from only one trial so consistency cannot be adequately gauged.
The sample size is less than 400 and according to the GRADE approach imprecision is present when continuous outcomes are compared in samples less than 400.