BioMed Research International / 2018 / Article / Tab 1 / Research Article
Daily 800 mg versus 600 mg Efavirenz for HIV Patients Treating Tuberculosis with a Rifampicin-Based Regimen: An Open Label Randomized Controlled Trial Table 1 Baseline and clinical characteristics of the trial population according to trial arm (800mg EFV-regimen or 600mg EFV-regimen). ALT= alanine transaminase. AST= aspartate transaminase. HBsAg= hepatitis B surface antigen. Anti-HCV= hepatitis C antibody. HIV= Human Immunodeficiency Virus. TB=tuberculosis.
EFV600 EFV800 Total Total 65 67 132 Age (years) mean (SD) 38.3 (9.9) 37.3 (9.8) 37.8 (9.8) Sex Male 51 (78.5%) 57 (86.4%) 108 (82.4%) Female 14 (21.5%) 9 (13.6%) 23 (17.6%) Ethnicity White 24 (36.9%) 21 (31.8%) 45 (34.4%) Black 8 (12.3%) 23 (34.8%) 31 (23.7%) Mixed 33 (50.8%) 22 (33.3%) 55 (42.0%) Weight(Kg) median (IQR) 57.0 (50.9, 62.3) 57.4 (51.0, 63.0) 57.0 (50.9, 62.9) Weight (Kg) ≤ 50 15 (23.1%) 13 (21.3%) 28 (22.2%) > 50 50 (76.9%) 48 (78.7%) 98 (77.8%) Tuberculosis Clinical Forms Pulmonary 34 (52.3%) 27 (40.3%) 61 (46.2%) Extrapulmonary 5 (7.7%) 5 (7.5%) 10 (7.6%) Ignored 1 (1.5%) 2 (3.0%) 3 (2.3%) Disseminated 25 (38.5%) 33 (49.2%) 58 (43.9%) Karnofsky Index median (IQR) 90 (80.0, 90.0) 90 (80.0, 90.0) 90 (80.0, 90.0) AST (U/L) median (IQR) 38.0 (28.5, 50.8) 40.0 (30.0, 48.0) 39.0 (30.0, 49.0) ALT (U/L) median (IQR) 38.0 (28.2, 47.0) 37.0 (27.0, 48.0) 37.0 (27.0, 48.0) Total Bilirubin (mg/dL) median (IQR) 0.4 (0.3, 0.6) 0.4 (0.3, 0.5) 0.4 (0.3, 0.6) CD4+ (cell/mm 3 ) ≤ 200 41 (66.1%) 45 (68.2%) 86 (67.2%) > 200 21 (33.9%) 21 (31.8%) 42 (32.8%) HIV viral load (log) < 5 21 (35.0%) 27 (43.5%) 48 (39.3%) ≥ 5 39 (65.0%) 35 (56.5%) 74 (60.7%) Previous TB treatment No 55 (91.7%) 55 (88.7%) 110 (90.2%) Yes 5 (8.3%) 7 (11.3%) 12 (9.8%) HBsAg Negative 44 (68.8%) 41 (64.1%) 85 (66.4%) Positive 2 (3.1%) 6 (9.4%) 8 (6.2%) Not done 18 (28.1%) 17 (26.6%) 35 (27.3%) Anti-HCV Negative 52 (81.2%) 51 (79.7%) 103 (80.5%) Positive 1 (1.6%) 4 (6.2%) 5 (3.9%) Not done 11 (17.2%) 9 (14.1%) 20 (15.6%)