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