Background
Methods
Setting
Patient selection, preparation, and follow-up
Treatment
Clinical measurements
Study design and definitions
Statistical analysis
Ethics
Sources of Funding
Results
Study cohort
Baseline characteristics (presented in Table 1)
Demography | [n (%)] |
---|---|
Children
| 151 |
Female
| 77 (51.0%) |
Age
| |
< 3 years | 39 (25.8%) |
3–5 years | 43 (28.5%) |
6–8 years | 43 (28.5%) |
≥ 9 years | 26 (17.2%) |
Median years [range] | 5.7 [.3–15.4] |
Parent status
|
[n (%)]
|
Two parents alive | 67 (44.4%) |
Only father living | 19 (12.6%) |
Only mother living | 27 (17.9%) |
Neither parent living | 38 (25.1%) |
WHO clinical stage [n (%)] |
[n (%)]
|
Stage 1 | 26 (17.2%) |
Stage 2 | 19 (12.6%) |
Stage 3 | 72 (47.7%) |
Stage 4 | 34 (22.5%) |
Anthropometry
|
Median (IQR)
|
Weight-for-age Z-score | -1.9 (-3.6 to -0.9) |
Height-for-age Z-score | -2.2 (-3.0 to -1.1) |
CD4 lymphocyte %
|
[n (%)]
|
< 5% | 52 (35.6%) |
5%-9% | 36 (24.7%) |
10%-14% | 28 (19.2%) |
15%-24% | 26 (17.8%) |
> 25% | 4 (2.7%) |
Median CD4% (IQR) | 7.4 (2.1–13.7) |
Laboratory values
|
Median (IQR)
|
Albumin (g/L) | 30.0 (26.0–35.0) |
ALT (IU/L) | 18.0 (14.0–28.3) |
Hemoglobin (g/dl) | 10.1 (8.9–11.0) |
Tuberculosis
|
[n (%)]
|
Present | 50 (33.1%) |
Other opportunistic infections
|
[n (%)]
|
Chronic gastroenteritis | 52 (34.4%) |
Pneumonia | 13 (8.6%) |
Oesophageal candidiasis | 13 (8.6%) |
PCP | 11 (7.3%) |
Cryptococcal meningitis | 1 (0.7%) |
CMV retinitis | 0 |
Toxoplosmosis | 0 |
Age | Regimen | NRTIs | NNRTI/PI | |||
---|---|---|---|---|---|---|
EFV | NVP | Kaletra™ | RTV | |||
< 3 years (n = 39) | 1st line | d4T/3TC | 7 | 1 | 23 | 0 |
2nd line | AZT/ddI | 0 | 0 | 0 | 0 | |
TB | d4T/3TC | 0 | 0 | 0 | 5 | |
≥ 3 years (n = 112) | 1st line | d4T/3TC | 61 | 0 | 1 | 0 |
2nd line | AZT/ddI | 1 | 0 | 1 | 0 | |
TB | d4T/3TC | 37 | 0 | 1 | 2 |
Primary Caregivers
Treatment responses
Mortality
Univariate analysis | Multivariate analysis | ||||
---|---|---|---|---|---|
Baseline Characteristic | No. of Deaths | Hazard ratio 95% CI |
p
| Hazard ratio 95% CI |
p
|
Gender
| |||||
Male | 6 | 1.00 | 1.00 | - | |
Female | 7 | 1.14 (0.38–3.40) | 0.810 | 2.78 (0.66–11.86) | 0.163 |
Age
| |||||
< 3 yrs | 5 | 1.00 | 1.00 | - | |
3–5 yrs | 2 | 0.35 (0.07–1.81) | 0.210 | 1.37 (0.21–9.04) | 0.747 |
6–8 yrs | 3 | 0.52 (0.12–2.16) | 0.365 | 0.25 (0.02–2.93) | 0.268 |
≥ 9 yrs | 3 | 0.92 (0.22–3.85) | 0.908 | 2.18 (0.44–10.85) | 0.342 |
WHO clinical stage
| |||||
Stage 1–3 | 7 | 1.00 | 1.00 | - | |
Stage 4 | 6 | 3.01 (1.01–8.95) |
0.048*
| 1.82 (0.41–8.03) | 0.430 |
Weight (**2 missing values) | |||||
≥ 5 Percentile | 1 | 1.00 | 1.00 | - | |
< 5 Percentile | 10 | 8.60 (1.10–67.15) |
0.040*
| 4.96 (0.45–55.31) | 0.193 |
CD4% (**1 missing value) | |||||
≥ 5% | 5 | 1.00 | - | - | |
< 5% | 7 | 2.65 (0.84–8.34) | 0.097 | - | - |
Tuberculosis
| |||||
Absent | 5 | 1.00 | 1.00 | - | |
Present | 8 | 3.39 (1.11–10.37) |
0.032*
| 1.08 (0.25–4.59) | 0.919 |
Pulmonary
| |||||
Absent | 9 | 1.00 |
-
|
-
| |
Present | 4 | 1.53 (0.47–5.01) | 0.480 |
-
|
-
|
Extrapulmonary
| |||||
Absent | 10 | 1.00 |
-
|
-
| |
Present | 3 | 3.06 (0.84–11.20) | 0.091 |
-
|
-
|
Chronic gastroenteritis
| |||||
Absent | 3 | 1.00 | 1.00 |
-
| |
Present | 10 | 6.69 (1.84–24.30) |
0.004*
| 12.34 (1.27–119.71) |
0.030*
|
Pneumonia
| |||||
Absent | 9 | 1.00 | 1.00 |
-
| |
Present | 4 | 5.23 (1.61–16.98) |
0.006*
| 4.03 (0.79–20.54) | 0.094 |
PCP
| |||||
Absent | 10 | 1.00 | 1.00 | - | |
Present | 3 | 3.81(1.05–13.86) |
0.042*
| 5.35 (0.84–33.86) | 0.075 |
Oesophageal candidiasis
| |||||
Absent | 12 | 1.00 | - | - | |
Present | 1 | 0.92 (0.12–7.04) | 0.932 | - | - |
Hemoglobin
| |||||
> 10 g/dl | 5 | 1.00 | - | - | |
≤ 10 g/dl | 8 | 1.87 (0.61–5.73) | 0.272 | - | - |
Primary caregiver HIV Status
| |||||
HIV negative or unknown | 10 | 1.00 |
-
| 1.00 | - |
HIV positive | 3 | 0.26 (0.07–0.95) |
0.041*
| 0.12 (0.02–0.88) |
0.037*
|
Primary caregiver receiving HAART at Sinikithemba
| |||||
Primary caregiver not in care | 12 | 1.00 | - | - | - |
Primary caregiver in care | 1 | 0.13 (0.02–1.01) | 0.051 | - | - |
Parent status
| |||||
Two parent alive | 6 | 1.00 | - | - | - |
One parent alive | 4 | 0.92 (0.26–3.26) | 0.896 | - | - |
Neither parent living | 3 | 0.82 (0.21–3.28) | 0.778 | - | - |
Pt# | Sex | Age (Yrs) | WHO Stage | WAZ | CD4% | ARV Regimen | ARV time to death (weeks) | ALB(g/L) | ALT(IU/L) | HGB(g/dl) | Suspected cause of death |
---|---|---|---|---|---|---|---|---|---|---|---|
1 | M | 0.3 | 4 | - | 37.6% | d4T/3TC/Kal | 09 | 25.0 | 14.0 | 9.9 | Chronic gastroenteritis |
2 | F | 7.5 | 4 | -9.52 | 7.9% | AZT/3TC/EFV | 20 | 18.0 | 33.0 | 10.7 | TB Miliary |
3 | F | 9.8 | 4 | -4.34 | 0.8% | d4T/3TC/EFV | 14 | 30.0 | 12.0 | 7.9 | TB Adenopathy |
4 | M | 3.0 | 4 | -4.81 | - | AZT/3TC/Kal | 10 | - | - | 9.1 | TB Lymph |
5 | F | 7.1 | 3 | -5.94 | 8.0% | d4T/3TC/EFV | 06 | 32.0 | 24.0 | 11.7 | Chronic gastroenteritis |
6 | F | 0.8 | 3 | -7.50 | 6.0% | d4T/3TC/Kal | 01 | 26.0 | 116.0 | 7.0 | Chronic gastroenteritis |
7 | F | 1.5 | 4 | -5.42 | 27.0% | d4T/3TC/RTV | 05 | 28.0 | 53.0 | 10.2 | TB Abdomen |
8 | F | 13.4 | 3 | -9.51 | 2.1% | d4T/3TC/EFV | 02 | - | - | 10.1 | Chronic gastroenteritis |
9 | M | 0.5 | 4 | -5.24 | 4.0% | d4T/3TC/Kal | 05 | 25.0 | 45.0 | 11.7 | Chronic gastroenteritis |
10 | M | 6.3 | 3 | - | 1.1% | AZT/3TC/EFV | 05 | 39.0 | 16.0 | 9.3 | Chronic gastroenteritis |
11 | M | 12.2 | 3 | -6.95 | 1.0% | d4T/3TC/EFV | 06 | - | - | 5.6 | Suspected PCP |
12 | F | 1.1 | 3 | -0.87 | 1.0% | d4T/3TC/Kal | 01 | 19.0 | 8.0 | 4.1 | Sepsis syndrome |
13 | M | 5.2 | 3 | -6.71 | 0.5% | d4T/3TC/EFV | 08 | 28.0 | 8.3 | 7.0 | Respiratory tract infection |