Table 2 Use of experimental antiretroviral drugs in a therapy initiation/change episode by demographic/epidemiological characteristics of patients and clinical and laboratory data at the time antiretroviral treatment (ART) initiation/change
| Â | Therapy initiation/change episodes including an experimental antiretroviral | Total therapy initiation/change episodes | p-value | |
|---|---|---|---|---|
| Â | In clinical trial N (%) | In EAP a N (%) | Â | Â |
Total reported AIDS cases in the clinical centre | Â | Â | Â | 0.02 |
0-250 | 34 (2.2) | 34 (2.2) | 1.575 | Â |
251-500 | 54 (2.7) | 46 (2.3) | 2.004 | Â |
501-1000 | 54 (2.4) | 42 (1.9) | 2.212 | Â |
> 1000 | 50 (1.4) | 78 (2.1) | 3.650 | Â |
Type of clinical centre | Â | Â | Â | 0.05 |
Non-teaching hospital | 113 (2.3) | 118 (2.4) | 4.993 | Â |
Teaching hospital | 79 (1.8) | 82 (1.8) | 4.448 | Â |
Gender | Â | Â | Â | 0.80 |
Females | 56 (1.9) | 58 (2.0) | 2.889 | Â |
Males | 136 (2.1) | 142 (2.2) | 6.552 | Â |
Age at ART initiation/change | Â | Â | Â | 0.48 |
18-34 | 67 (2.5) | 56 (2.1) | 2.687 | Â |
35-39 | 48 (1.8) | 60 (2.3) | 2.609 | Â |
40-44 | 40 (2.0) | 37 (1.9) | 1.960 | Â |
> = 45 | 37 (1.7) | 47 (2.2) | 2.185 | Â |
Place of birth | Â | Â | Â | 0.36 |
Italy | 178 (2.0) | 191 (2.2) | 8.774 | Â |
Other countries | 14 (2.1) | 9 (1.3) | 667 | Â |
Years of education | Â | Â | Â | 0.22 |
< = 8 | 78 (1.7) | 90 (1.9) | 4.624 | Â |
9-13 | 55 (2.2) | 56 (2.2) | 2.530 | Â |
> 13 | 10 (2.3) | 11 (2.5) | 432 | Â |
Unknown | 49 (2.6) | 43 (2.3) | 1.855 | Â |
Marital status | Â | Â | Â | 0.29 |
Never married | 93 (1.9) | 94 (1.9) | 4.864 | Â |
Married | 99 (2.2) | 106 (2.3) | 4.577 | Â |
Occupational status | Â | Â | Â | 0.53 |
Unemployed | 47 (2.0) | 47 (2.0) | 2.345 | Â |
Employed | 138 (2.1) | 145 (2.2) | 6.675 | Â |
Other | 7 (1.7) | 8 (1.9) | 421 | Â |
HIV exposure category | Â | Â | Â | 0.08 |
Heterosexual | 73 (2.0) | 68 (1.9) | 3.597 | Â |
Homosexual/Bisexual | 48 (2.4) | 58 (2.9) | 2.010 | Â |
IDU (Active+Former) | 56 (1.7) | 65 (2.0) | 3.237 | Â |
Other/Unknown | 15 (2.5) | 9 (1.5) | 597 | Â |
Nadir CD4 cell count (cells/ml) | Â | Â | Â | 0.07 |
< 200 | 86 (2.0) | 104 (2.4) | 4348 | Â |
200-349 | 51 (1.7) | 51 (1.7) | 2965 | Â |
> = 350 | 55 (2.6) | 45 (2.1) | 2128 | Â |
Clinical and laboratory data at treatment initiation/change | Â | Â | Â | Â |
Clinical AIDS | Â | Â | Â | 0.10 |
No | 161 (2.1) | 151 (2.0) | 7.600 | Â |
Yes | 31 (1.7) | 49 (2.7) | 1.841 | Â |
CD4 cell count (cells/ml) | Â | Â | Â | 0.10 |
< 200 | 64 (2.7) | 56 (2.3) | 2387 | Â |
200-349 | 45 (1.8) | 49 (2.0) | 2444 | Â |
> = 350 | 83 (1.8) | 95 (2.1) | 4610 | Â |
HIV RNA (log 10 copies/ml) | Â | Â | Â | < 0.001 |
< 2 | 22 (1.0) | 31 (1.4) | 2275 | Â |
2-3 | 48 (2.0) | 53 (2.3) | 2345 | Â |
> = 4 | 122 (2.5) | 116 (2.4) | 4812 | Â |
Presence of hepatic comorbidities | Â | Â | Â | 0.01 |
No | 127 (2.4) | 103 (1.9) | 5313 | Â |
Yes | 65 (1.6) | 97 (2.3) | 4128 | Â |
Presence of other b comorbidities | Â | Â | Â | 0.15 |
No | 179 (2.1) | 177 (2.1) | 8384 | Â |
Yes | 13 (1.2) | 23 (2.2) | 1057 | Â |
Number of experienced drugs | Â | Â | Â | < 0.001 |
Naive | 117 (3.2) | 42 (1.2) | 3.647 | Â |
3-4 | 44 (1.2) | 74 (2.1) | 3.524 | Â |
5-7 | 15 (0.9) | 50 (3.0) | 1.675 | Â |
> = 8 | 16 (2.7) | 34 (5.7) | 595 | Â |
Number of failed drugs | Â | Â | Â | < 0.001 |
0-2 | 153 (2.3) | 94 (1.4) | 6.727 | Â |
3-4 | 26 (1.3) | 62 (3.3) | 2.047 | Â |
> = 5 | 13 (1.9) | 44 (6.6) | 667 | Â |