Please select the eligibility criteria that correspond to the clinical trial below.
Title: International Multicenter Trial for the Evaluation of a Four-Drug Fixed Dose Combined Tablet Daily in the Initial Intensive Phase of Chemotherapy Followed by a Two-Drug Fixed Dose Combined Tablet Three Times a Week in the Continuation Phase for the Treatment of Pulmonary Tuberculosis
Brief Summary: The use of fixed-dose combined (FDC) drugs in the treatment of tuberculosis by National Tuberculosis Programmes has been recommended by both the International Union Against Tuberculosis and Lung Disease (The Union) and the World Health Organisation. The advantages of FDC drugs include preventing the emergence of drug resistance due to monotherapy, reducing the risk of incorrect dosage, simplifying procurement and prescribing practices, aiding adherence and facilitating directly observed treatment. Recent bioavailability studies of four-drug FDC tablets have demonstrated satisfactory results. In this study, we are testing the efficacy of this compound, when given in the initial intensive phase of treatment of patients with newly diagnosed smear positive pulmonary tuberculosis. This will be followed by four months treatment with a two-drug FDC of rifampicin and isoniazid.


Options:
A: Inclusion Criteria:

* Patients with newly diagnosed pulmonary tuberculosis
* two sputum specimens positive for acid-fast bacilli on direct smear microscopy
* no previous anti-tuberculosis chemotherapy
* aged 18 years and over
* firm home address that is readily accessible for visiting for the duration of the trial (including follow up period)
* agree to participate in the study and to give a sample of blood for HIV test

Exclusion Criteria:

* patients in a moribund state,
* TB meningitis,
* pre-existing diseases: insulin-dependent diabetes, liver or kidney disease, blood disorders, peripheral neuritis,
* pregnancy or breast feeding,
* psychiatric illness
* alcoholism
* contraindication to any medications in the study regimens
B: Inclusion Criteria:

1. HIV-infected
2. Age \>=18 years
3. Tuberculin skin test positive or negative
4. Laboratory:

   * Hemoglobin (Hgb) \>6.5 gm/dl;
   * Neutrophil count \>1,000 cells/mm3;
   * Platelets \>75,000/mm3;
   * AST (SGOT) \<122 U/L;
   * Creatinine \<1.5 mg/dl;
   * Beta HCG = negative
5. Karnofsky performance status \>=60
6. Signed informed consent

Exclusion Criteria:

1. History of TB in the last 3 years or current active TB
2. History of noncompliance to chronic therapies
C: Inclusion Criteria:

* HIV infected
* Tuberculin test (PPD) positive 5 mm or greater
* Chest x-ray negative for pulmonary tuberculosis

Exclusion Criteria:

* Pregnant or breastfeeding
D: Inclusion Criteria:

* HIV-infected children
* Resident in Cape Town
* Informed consent obtainable
* weight \> 2.5kg
* Access to transport
* HAART use for not less than 2 months but not more than 12 months with no significant demonstrated toxicity and good adherence

Exclusion Criteria:

* Chronic diarrhoea
* Current use of INH prophylaxis
* Prior hypersensitivity to INH prior history of allergy to sulphur drugs
* Prior history of allergy to sulphur drugs
* Severe anaemia (haemoglobin less than 7 gm/dl)
* Neutropenia (absoloute neutrophil count less than 400 cells)
* Thrombocytopenia (platelet count \< 50 000/uL)
* Non-reversible renal failure
* Clinical hepatitis
* Exposure to household TB contact, requiring INH prophylaxis

Answer: A