Tuberculosis Preventive Therapy Among Latent Tuberculosis Infection in HIV-infected Individuals

Inclusion Criteria

• •1. Documented HIV-1 infection by standard HIV test or plasma HIV-1 RNA viral load and received ART within 12 months. Participants received ART more than 12 months would be allowed if CD4 cell counts is less than 350 cells/mm3
• •2. 18 years and older
• •3. Evidence of latent TB infection, either by TST ≥5 mm or positive interferon gamma release assay (IGRA) or history of close contact with active pulmonary TB\* within 3 months prior entry visit or residing in a high TB burden area\*\* NOTE \* close contact is referred to person living/sharing in the same room with active pulmonary TB participants for \> 4 hours/day
• •\*\* high TB burden areas are defined as areas with an estimated or reported TB prevalence of 100 to 300/100,000, according to the WHO. Thailand is included in high TB burden areas.
• •4. Laboratory values obtained within 30 days prior to entry
• •* Absolute neutrophil count (ANC) \>750 cells/mm3
• •* Hemoglobin \>7.4 g/dL
• •* Platelet count \>50,000/mm3
• •* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) \<3x upper limit of normal (ULN)
• •* Total bilirubin \<2.5 X ULN
• •5. Chest radiograph or chest computed tomography (CT) scan without evidence of active tuberculosis, unless one has been performed within 90 days prior to entry.
• •6. Female participants who are participating in sexual activity that could lead to pregnancy must agree to use one reliable non-hormonal form of contraceptive (i.e., condoms, IUD, diaphragm) during RPT treatment and contraception should be remain to 6 weeks post RPT NOTE Female participants who are not of reproductive potential or whose male partner(s) have undergone successful vasectomy with documented azoospermia or have documented azoospermia are eligible without requiring the use of contraceptives. Participant-reported history is acceptable documentation of menopause, hysterectomy, or bilateral oophorectomy or bilateral tubal ligation.
• •7. All participants must agree not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, donate sperm, in vitro fertilization) while receiving RPT and for 6 weeks after stopping this drug.
• •8. Body weight \> 40 kg
• •9. Ability and willingness of participant to provide informed consent