Characteristic | RAL arm | ENF arm |
---|---|---|
(n = 84) | (n = 85) | |
Age (years) | ||
Median | 47.6 | 48.4 |
Interquartile range | 43.0; 53.7 | 44.0; 54.3 |
Male sex, no. (%) | 70 (83) | 73 (86) |
Route of HIV infection, no. (%) | ||
Sexual | 73 (87) | 74 (87) |
Injection-drug use | 5 (6) | 5 (6) |
Other or unknown | 6 (7) | 6 (7) |
CDC stage, no. (%) | ||
A | 16 (19) | 14 (16) |
B | 26 (31) | 24 (28) |
C | 42 (50) | 47 (55) |
History of viral hepatitis co-infection | ||
HBs Ag positive | 1 (1) | 0 (0) |
HCV RNA positive | 6 (7) | 4 (5) |
Cirrhosis | 0 (0) | 0 (0) |
Non alcoolic fatty liver disease | 9 (11) | 5 (6) |
Alcohol consumption | ||
≥3 times per week | 11 (13) | 19 (22) |
ALAT levels at baseline | ||
Grade 0 | 75 (89) | 76 (89) |
Grade 1 | 8 (10) | 7 (8) |
Grade 2 | 0 (0) | 1 (1) |
Grade 3 | 1 (1) | 0 (0) |
Grade 4 | 0 (0) | 0(0) |
Body mass index (BMI) | ||
Median | 22.3 | 22.6 |
Interquartile range | 19.9; 24.0 | 20.6; 24.8 |
Baseline CD4 cells per μL | ||
Median | 410 | 374 |
Interquartile range | 259; 505 | 277; 535 |
Plasma HIV RNA < 50 cp/mL, no. (%) | 71 (85) | 75 (88) |
Duration of prior antiretroviral therapy (years) | ||
Median | 13.7 | 13.6 |
Interquartile range | 12.1; 15.0 | 11.7; 15.4 |
Duration of prior enfuvirtide therapy (years) | ||
Median | 2.5 | 2.2 |
Interquartile range | 1.6; 3.5 | 1.4; 3.4 |
Number of antiretroviral drugs in baseline regimen (including enfuvirtide) | ||
Median | 4 | 4 |
Interquartile range | 4; 5 | 4; 5 |
Antiretroviral drugs in baseline regimen (apart from enfuvirtide) | ||
Protease inhibitors, no. (%) | 83 (99) | 85 (100) |
Tipranavir/ritonavir | 37 (44) | 29 (34) |
Darunavir/ritonavir | 30 (36) | 34 (40) |
Atazanavir/ritonavir | 2 (2) | 2 (2) |
Lopinavir/ritonavir | 9 (11) | 15 (18) |
Fosamprenavir/ritonavir | 11 (13) | 11 (13) |
NRTIs, no. (%) | 79 (94) | 81 (95) |
Tenofovir | 50 (60) | 46 (54) |
Lamivudine | 36 (43) | 32 (38) |
Emtricitabine | 26 (31) | 28 (33) |
Abacavir | 31 (37) | 29 (34) |
NNRTIs, no. (%) | 8 (10) | 5 (6) |
Nevirapine | 5 (6) | 1 (1) |
Efavirenz | 3 (4) | 3 (4) |
Etravirine | 0 (0) | 1 (1) |