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%)