| Methods |
517 individuals, centralized randomisation, stratified by study unit, permuted blocks; blinding: providers yes, participants yes, assessors yes. 34 (7%) lost to follow‐up; intention to treat analysis |
| Participants |
HIV positive patients attending AIDS research clinics in the US. Inclusion criteria: Anergic (PPD less than 5mm induration AND less than 2mm induration to mumps antigen and tetanus toxoid); age >= 13+ years; no active TB; written consent. Exclusion Criteria: household TB contact in past year, on drugs with activity against TB, acute hepatitis, peripheral neuropathy, history of positive PPD, intolerance to study drug, treatment for >= 1 month with drug active against TB. |
| Interventions |
1) Control (Placebo) plus pyridoxine 50mg daily for 6months.
2) INH 300mg plus pyridoxine 50mg daily for 6months. |
| Outcomes |
1) Active TB (primary end point): positive culture from any source. 2) Probable TB: clinical features of TB plus a response to anti‐TB drugs or autopsy evidence of granulomata containing AFB. 3) Progression of HIV disease: first occurrence of an AIDS‐defining condition. 4) Death. 5) Adverse effects.‐‐ Mean duration of follow‐up 33.5 months. |
| Notes |
Use of ART 73.2% in control arm and 72.7% in INH arm. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
| Blinding?
All outcomes |
Low risk |
Blinding of providers, participants and assessors |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
7% lost to follow‐up |
