Please select the eligibility criteria that correspond to the clinical trial below.
Title: Long Term Study of 2 Isoniazid (INH) Prophylactic Regimens With Concomitant Cotrimoxazole (CTX) in HIV-infected Children - Impact on Morbidity, Mortality, Bacterial Resistance and Incidence of Tuberculosis
Brief Summary: The study involves use of isoniazid and cotrimoxazole as strategies for preventing infections in HIV-infected children and reducing mortality. Cotrimoxazole is well known to reduce mortality and infections in HIV-infected children and is currently the recommended standard of care. However, isoniazid has only been studied in HIV-infected adults (in whom it has been shown to substantially reduce the incidence of tuberculosis). In a randomised controlled study of isoniazid in HIV-infected children, the investigators found that INH reduced mortality and tuberculosis incidence in excess of 50%; the data safety monitoring board recommended termination of the placebo arm given the beneficial effects of INH. The investigators therefore aim to follow-up these children to compare the long term impact of two different INH and CTX preventive regimens (daily versus thrice weekly) on morbidity, mortality, adherence and incidence of adverse reactions. The investigators also aim to investigate the efficacy, safety and tolerability of INH compared with placebo for prevention of TB in children receiving HAART as the benefit in this group is unknown.


Options:
A: Inclusion Criteria:

* all people who is LTBI, and have ability to sign the informed concent

Exclusion Criteria:

* previously adverse effect from anti-TB medication complete treatment of TB in the pass; active TB AST, ALT \> 3 times of normal limit platelet \< 150 k/mm3 T-bil \> 2 times of normal limit
B: 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
C: Inclusion Criteria:

* patients with positive TST and the suitable criteria for treatment, in accordance with the guidelines of the CDC:

Exclusion Criteria:

* HIV infection.
* Hepatopathy
* Previous treatment of of latent tuberculosis infection.
* Allergy to drugs.
D: INCLUSION criteria:

* Males or nonpregnant, non-nursing females \> 2 years old.
* Tuberculin (PPD) skin test reactors at high risk for developing TB but without evidence of active TB. High-risk reactors are defined as:

  1. Household and other close contacts of persons with culture-confirmed TB who are TST-positive as part of a contact investigation conducted within two years of the date of enrollment. Close contact is defined as \> 4 hours in a shared airspace during a one-week period. Among close contacts, a positive TST is defined as \> 5 mm induration after 5 TU of PPD placed intradermally using the Mantoux technique.
  2. TST converters--converting from a documented negative to positive TST within a two-year period. This is defined as persons with a tuberculin skin test of \> 10 mm within two years of a nonreactive test or persons with an increase of \> 10 mm within a two-year period.
  3. HIV-seropositive, TST positive (\> 5 mm induration) persons.
  4. Persons with \> 2 cm2 of pulmonary parenchymal fibrosis on chest X-ray, no prior history of TB treatment, \> 5 mm induration on TST, and 3 sputum cultures negative for M. tuberculosis on final report.
* HIV-seropositive close contacts of persons with culture-confirmed TB, regardless of TST status. In addition, HIV-seropositive close contacts of persons with culture-confirmed TB who have a documented history of completing an adequate course of treatment for active TB or latent TB infection, are also eligible.
* Willing to provide signed informed consent, or parental consent and participant assent.

EXCLUSION criteria:

* Current confirmed culture-positive or clinical TB
* Suspected TB (as defined by the site investigator)
* Tuberculosis resistant to isoniazid or rifampin in the source case
* A history of treatment for \> 14 consecutive days with a rifamycin or \> 30 consecutive days with INH during the previous 2 years.
* A documented history of a completing an adequate course of treatment for active TB or latent TB infection in a person who is HIV-seronegative.
* History of sensitivity/intolerance to isoniazid or rifamycins
* Serum aminotransferase aspartate (AST, SGOT) \> 5x upper limit of normal among persons in whom AST is determined
* Pregnant or nursing females
* Persons currently receiving or planning to receive HIV-1 protease inhibitors or nonnucleoside reverse transcriptase inhibitors in the first 90 days after enrollment.
* Weight \< 10.0 kg

Answer: B