Please assess the completion status of the following clinical trial:

Trial Title: Daily Isoniazid to Prevent Tuberculosis in Infants Born to Mothers With HIV

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: PREVENTION
- Time Perspective: None
- Masking: TRIPLE
- Phase: PHASE2/PHASE3
- Number of Arms: 4.0

Eligibility Criteria:
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

- Gender: ALL
- Minimum Age: 91 Days
- Maximum Age: 120 Days
- Healthy Volunteers: t

Study Arms:
- HIVneg/INH (Type: EXPERIMENTAL): Perinatally exposed, HIV-uninfected (HIVneg) children receiving Isoniazid (INH)10-20 mg/kg orally once a day for 96 weeks + Trimethoprim/Sulfamethoxazole (TMP/SMX) 5 mg/kg of TMP component orally once a day until HIV status is confirmed and child is no longer at risk of acquiring HIV through breastfeeding
- HIVneg/PL (Type: PLACEBO_COMPARATOR): Perinatally exposed, HIV-uninfected (HIVneg) children receiving Isoniazid placebo (PL) orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until HIV status is confirmed and child is no longer at risk of acquiring HIV through breastfeeding
- HIVpos/INH (Type: EXPERIMENTAL): HIV-infected (HIVpos) children receiving Isoniazid (INH) 10-20 mg/kg orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until one year of age. TMP/SMX may have been continued after one year of age according to WHO guidelines.
- HIVpos/PL (Type: PLACEBO_COMPARATOR): HIV-infected (HIVpos) children receiving Isoniazid placebo (PL) orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until one year of age. TMP/SMX may have been continued after one year of age according to WHO guidelines.

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: terminate
termination_type: lack of efficacy