Please select the eligibility criteria that correspond to the clinical trial below.
Title: Novel TB Prevention Regimens for HIV-Infected Adults
Brief Summary: This study compares three different tuberculosis (TB) prevention regimens against the standard regimen of 6 months of isoniazid. It is being conducted in Soweto, South Africa. People who are HIV positive and have a positive tuberculin skin test without signs of active tuberculosis may join.


Options:
A: Inclusion Criteria:

* Mother is HIV-infected. Hard copy documentation of the mother's HIV infection is unnecessary if a positive DNA PCR from her infant is available.
* Received Bacille Calmette-Guerin (BCG) vaccine up to and including the 30th day of life and at least 90 days prior to study entry
* Able to complete all study requirements
* Physician assessment of age-appropriate neurodevelopment in which the chronological age is corrected for gestational age for prematurely born infants
* Parent or legal guardian able and willing to provide signed informed consent
* Plan to live in the study area for at least 4 years
* For inclusion in HIV-infected stratum, infant must have a positive HIV-1 DNA PCR; for inclusion in HIV-uninfected stratum, infant must have a negative HIV-1 DNA PCR performed at \>= 4 weeks of age

Exclusion Criteria:

* Previous diagnosis of TB infection, TB disease or current treatment for TB infection or TB disease
* Previous receipt of INH
* Contact with a known acid fast bacilli (AFB) sputum smear or culture-positive case of TB before study entry
* Current acute or recurrent (3 or more prior episodes) lower respiratory tract disease
* Chronic persistent diarrhea
* Failure to thrive
* Contraindications for use of INH or TMP/SMX
* Require certain medications
* Known or suspected immune system diseases other than HIV
* Current or previous diagnosis of or treatment for cancer
* Current immunosuppressive therapy greater than 1 mg/kg/day of prednisone or equivalent
* Anticipated long-term oral or intravenous corticosteroid therapy (greater than 3 weeks). Those receiving nonsteroidal anti-inflammatory agents and inhaled corticosteroids are not excluded.
* Grade 3 or greater AST/SGOT, ALT/SGPT, ANC, hemoglobin, platelet count, rash, neuropathy, or myopathy at screening
* Any Grade 4 clinical or laboratory toxicity within 14 days prior to study entry
* Other acute or chronic conditions that, in the opinion of the investigator, may interfere with the study
B: Inclusion Criteria:

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

Exclusion Criteria:

* Pregnant or breastfeeding
C: 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
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: B