Table 1. Baseline Characteristics of Patients Randomized to 3 Antituberculosis Therapy Regimens.
| Characteristic | Regimen | ||||
|---|---|---|---|---|---|
| Daily (n = 111) | Part-Daily (n = 110) | Intermittent (n = 110) | |||
| Demographic characteristics | |||||
| Age, mean (SD), y | 38 (9) | 39 (9) | 40 (9) | ||
| Male, No. (%) | 86 (77) | 81 (74) | 84 (76) | ||
| Weight, mean (SD), kg | 42.78 (8.28) | 42.60 (7.54) | 44.50 (7.47) | ||
| BMI, mean (SD) | 16.79 (2.71) | 16.87 (2.66) | 17.36 (2.74) | ||
| Site of lesion, No. | |||||
| Pulmonary | 70 | 77 | 68 | ||
| Pulmonary with extrapulmonary | 41 | 33 | 42 | ||
| Opportunistic infections at baseline, No. | 37 | 36 | 32 | ||
| Pneumocystitis carinii pneumonia | 8 | 2 | 4 | ||
| Oral candidiasis | 15 | 23 | 19 | ||
| Herpes zoster or herpes simplex | 6 | 8 | 7 | ||
| Hepatitis B and C | 8 | 2 | 3 | ||
| Mycobacterium avium intracellulare | 2 | 1 | 1 | ||
| History of alcohol intake, No. | 54 | 46 | 52 | ||
| Smoker, No. | 40 | 37 | 47 | ||
| Transmission, No. | |||||
| Heterosexual | 90 | 87 | 88 | ||
| Homosexual | 1 | 2 | 3 | ||
| Intravenous drug user | 7 | 2 | 3 | ||
| Others | 7 | 8 | 8 | ||
| Biochemical and hematological parameters | |||||
| RBC count, median (range), ×106 cells/μL | 3.55 (3.01-4.12) | 3.54 (2.98-4.13) | 3.62 (3.14-4.15) | ||
| WBC count, median (range), ×103 cells/μL | 6.4 (4.4-8.9) | 6.7 (4.7-9.5) | 6.8 (4.9-8.3) | ||
| Platelets, median (IQR), ×103 cells/μL | 3.09 (2.36-4.07) | 3.12 (1.94-4.24) | 3.15 (2.44-4.23) | ||
| Hemoglobin, mean (SD), g/dL | 9.81 (2.14) | 9.43 (2.08) | 9.88 (2.05) | ||
| Hematocrit, mean (SD), % | 30.07 (9.97) | 28.96 (8.8) | 29.66 (6.66) | ||
| Plasma glucose, median (IQR), mg/dL | 102 (92-120) | 105 (96-124) | 102 (90-125) | ||
| Serum creatinine, mean (SD), mg/dL | 0.77 (0.19) | 0.73 (0.21) | 0.73 (0.18) | ||
| Blood urea, mean (SD), mg/dL | 21.40 (8.90) | 20.91 (9.18) | 21.35 (7.67) | ||
| Serum bilirubin, median (IQR), mg/dL | 0.5 (0.4-0.7) | 0.4 (0.4-0.7) | 0.5 (0.4-0.7) | ||
| Serum AST, median (IQR), IU/L | 37 (24-66) | 35 (23-61) | 34 (25-52) | ||
| Serum ALT, median (IQR), IU/L | 24 (16-43) | 22 (13-33) | 20 (14-35) | ||
| Serum AP, median (IQR), IU/L | 123 (86-218) | 108 (74-189) | 125 (82-240) | ||
| Immunological parameters | |||||
| Receiving ART at ATT initiation, No. | 23 | 16 | 22 | ||
| Not receiving ART during ATT, No. | 11 | 22 | 13 | ||
| Stavudine, lamivudine, efavirenz or zidovudine, lamivudine, efavirenz regimen, No. | 60 | 51 | 54 | ||
| Tenofovir, lamivudine, efavirenz regimen, No. | 40 | 37 | 43 | ||
| CD4 lymphocyte count, median (IQR), cells/μL | 130 (65-226) | 144 (71-261) | 137 (68-258) | ||
| CD8 lymphocyte count, median (IQR), cells/μL | 600 (334-957) | 573 (337-1048) | 707 (356-1018) | ||
| CD4/CD8 ratio, median (range) | 0.23 (0.11-0.4) | 0.23 (0.16-0.40) | 0.20 (0.11-0.38) | ||
| Viral load, mean (SD), log10 copies/mL | 4.91 (1.29) | 5.00 (1.14) | 4.93 (1.26) | ||
| ATT-ART interval, median (IQR), d | 16 (2-36) | 17 (5-47) | 15 (1-34) | ||
| CD4 lymphocyte count <100 cells/μL, No. (%) | 45 (41) | 38 (34) | 43 (39) | ||
| Chest radiograph characteristics | |||||
| >3 Zones, No./total No. (%) | 71/111 (64) | 82/110 (75) | 67/110 (61) | ||
| Bilateral lesions, No. | 71 | 71 | 65 | ||
| Lower lung TB, No. | 69 | 66 | 57 | ||
| Cavitation, No. | 23 | 18 | 16 | ||
| Pleural, No. | 24 | 18 | 17 | ||
| Military, No. | 13 | 9 | 10 | ||
| Mediastinal adenitis, No. | 31 | 30 | 25 | ||
| Others, No. | 2 | 3 | 2 | ||
| Microbiological characteristics | |||||
| Sputum smear grade 2+, No./total No. | 52/111 | 52/110 | 52/110 | ||
| Culture grade ≥2+, No./total No. | 79/111 | 68/110 | 66/110 | ||
| Sensitive to all first-line drugs, No./total No. (%) | 92/99 (93) | 82/97 (85) | 85/97 (88) | ||
| Isoniazid resistance, No. | 5 | 11 | 11 | ||
| MDR TB at baseline (isoniazid and rifampicin resistance), No. | 4 | 4 | 2 | ||
Abbreviations: ALT, alanine transaminase; AP, alkaline phosphatase; ART, antiretroviral therapy; AST, aspartate transaminase; ATT, antituberculosis therapy; BMI, body mass index (calculated as weight in kilograms divided by height in meters squared; IQR, interquartile range; MDR, multidrug-resistant; RBC, red blood cell; TB, tuberculosis; WBC, white blood cell.
SI conversion factors: To convert RBC count to ×1012/L, multiply by 1.0. To convert WBC count to ×109/L, multiply by 0.001. To convert platelet count to ×109/L, multiply by 1.0. To convert hemoglobin to g/L, multiply by 10.0. To convert hematocrit to proportion of 1, multiply by 0.01. To convert plasma glucose to mmol/L, multiply by 0.0555. To convert serum creatinine to μmol/L, multiply by 76.25. To convert blood urea to mmol/L, multiply by 0.357. To convert serum bilirubin to μmol/L, multiply by 17.104. To convert serum AST to μkat/L, multiply by 0.0167. To convert serum ALT to μkat/L, multiply by 0.0167. To convert serum AP to μkat/L, multiply by 0.0167.