Criteria

OFLOTUB trial [13]

RAFA trial [14]

Inclusion criteria

Patients with pulmonary tuberculosis 18 - 65 years old TB treatment naïve Informed consent

TB/HIV co-infected patients (pulmonary and extra-pulmonary tuberculosis) > 18 years old ARV naïve 50 ≤ LT CD4 ≤ 350 Cells/mm³ Informed consent

Non-inclusion criteria

None

Patients co-infected with HIV2, alcohol consumption or concomitant treatment incompatible with the RAFA trial, breastfeeding women or women who don’t want to use a contraception method during the study period

Exclusion criteria

Patients with a history of TB treatment within the last 3 years, with diabetes mellitus or non-insulin dependent diabetes mellitus requiring treatment, Concomitant infections requiring anti-infective treatment especially with ARVs, some HIV patients at Stage 3, and all patients at Stage 4 of the WHO classification

MDR-TB patients

PK study countries

Benin, Guinea, Kenya and Senegal

Quantification of anti-TB drugs plasma concentrations of the patients randomized in the two study arms:

§ Gatifloxacin arm (Rifampicin, Isoniazid, Pyrazinamide, and Gatifloxacin)

§ Control arm (Rifampicin, Isoniazid, Pyrazinamide, and Ethambutol)

Benin and Guinea

Quantification of anti-TB drugs (Rifampicin, Isoniazid, Ethambutol, and Pyrazinamide) plasma concentrations of the patients randomized in the three study arms:

§ arm A (First-line anti-TB + ARVs after two weeks)

§ arm B (First-line anti-TB + ARVs after two months)

§ arm C (First-line anti-TB with high-dose of Rifampicin + ARVs after two months)