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Causes of death and risk factors
of mortality in HIV-infected
patients treated for tuberculosis
enrolled in the CAMELIA trial
(ANRS 1295/12160 – CIPRA KH001/10425)
O. Marcy, D. Laureillard, S. Chan, Y. Madec, C.
Mayaud, L. Borand, N. Prak, C. Kim, K.K. Lak, C. Hak,
B. Dim, T. Sok, A.E. Goldfeld and F.X. Blanc
21 July, 2011
Oral poster discussion session, 6th IAS Conference, Roma
www.ias2011.org
Study design
• HIV+ patients with AFB+ tuberculosis (TB)
and CD4 ≤ 200/mm3
• TB regimen: 2RHEZ/4RH
• Randomized to start ART (D4T/3TC/EFV)
• Early: 2 weeks after TB treatment onset
• Late: 8 weeks after TB treatment onset
• Primary endpoint: survival
• Causes of death were secondarily assessed
ANRS 1295/12160 – CIPRA KH001/10425 study
www.ias2011.org
Mortality
• Median follow-up duration: 25 months
• 149 / 661 (22%) enrolled patients died
• Place of death:
– 63 (42%) deaths occurred at home
– 86 (58%) occurred in hospital
Period of time
Deaths
n (%)
Mortality rate / 100 PYs
(95% CI)
Inclusion to Wk 26
87 (58)
28.9 (23.4 – 35.6)
>Wk 26 to Wk 50
22 (15)
8.5 (5.6 – 12.9)
>Wk 50
40 (27)
4.9 (3.6 – 6.7)
ANRS 1295/12160 – CIPRA KH001/10425 study
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Causes of death
Early
n (%)
Late
n (%)
Total
n (%)
Tuberculosis
Drug-induced toxicity
Gastrointestinal disorders
Infection dis. and PML
Respiratory distress
Cachexia
Neurologic disorders
Hepatic disorders
IRIS
Neoplasia
Suicide
Road accident
Unknown
13 (22)
5 (9)
6 (10)
6 (10)
6 (10)
5 (9)
3 (5)
3 (5)
6 (10)
2 (3)
4 (7)
29 (32)
12 (13)
10 (11)
7 (8)
4 (5)
3 (3)
5 (6)
5 (6)
3 (3)
1 (1)
2 (2)
9 (10)
42 (28)
17 (12)
16 (11)
13 (9)
10 (7)
8 (5)
8 (5)
8 (5)
6 (4)
3 (2)
3 (2)
2 (1)
13 (9)
Total
59 (100)
90 (100)
149 (100)
ANRS 1295/12160 – CIPRA KH001/10425 study
www.ias2011.org
Risk factors of mortality
Arm
Age, years
BMI, kg/m2
Karnofsky score
AST, ULN
TB location
TB drug resistance
Early
Late
≤29
30-39
≥40
<16
16-17
17.1-18.5
>18.5
≥80
50-70
≤40
≤1.25
>1.25
Pulmonary
Extra-pulmonary
Disseminated
Non-TB mycobact.
No
Yes
Yes, MDR
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Adjusted HR (95% CI
1
1.61 (1.16 – 2.27)
1
1.26 (0.81 – 1.98)
1.87 (1.18 – 2.95)
1.61 (1.03 – 2.54)
0.84 (0.47 – 1.48)
1.08 (0.62 – 1.91)
1
1
1.60 (0.83 – 3.09)
4.69 (2.17 – 10.11)
1
1.53 (1.08 – 2.18)
1
1.02 (0.52 – 2.01)
2.55 (1.78 – 3.65)
3.21 (1.35 – 7.63)
1
1.10 (0.68 – 1.74)
7.65 (3.45 – 16.99)
p
0.006
0.03
0.02
<0.001
0.02
<0.001
<0.001