Please select the eligibility criteria that correspond to the clinical trial below.
Title: Urgent Versus Post-Stabilization ART in HIV-1 Infected Children With Severe Co-Infections
Brief Summary: Design: Randomized clinical trial involving hospitalized HIV-1 infected children. Children will be randomized to randomized to urgent (\<48 hours) versus early antiretroviral therapy (7-14 days). This trial will be unblinded.

Population: Hospitalized HIV-1 infected children who are antiretroviral therapy (ART) naïve ≤ 12 years of age.

Sample size: 360 children will be randomized (180 per arm).

Treatment: All infants will be treated with ART according to World Health Organization (WHO) and Kenyan national guidelines.

Study duration: Enrollment into the study will occur over the course of 36-48 months and each infant will be routinely followed for a maximum of 6 months.

Study site: Kenyan hospitals.

Primary hypothesis:

HIV-1 infected children hospitalized with severe co-infection either may be unsalvageable due to too far advanced immunosuppression/co-infection or may benefit from urgent ART.

Secondary hypotheses:

Urgent ART during an acute infection could potentially result in increased risk of immune reconstitution inflammatory syndrome (IRIS) or drug toxicities/interactions.

Specific aims:

1. To compare the 6 month all-cause mortality rate, incidence of immune reconstitution inflammatory syndrome (IRIS), and incidence of drug toxicity in HIV-1 infected children (≤ 12 years old) presenting to hospital with a serious infection randomized to urgent (\<48 hours) versus early ART (7-14 days).
2. To determine co-factors for mortality, IRIS, and drug toxicity. Potential cofactors will include: baseline weight-for-age, height-for-age, weight-for-height (Z-scores), CD4, HIV-1 RNA, type of co-infection, age, rate of viral load and CD4 change following ART, immune activation markers, pathogen and HIV-1 specific immune responses.

Secondary aim: To determine etiologies of IRIS and to compare immune reconstitution to HIV, TB, EBV and CMV following ART overall and in each trial arm.


Options:
A: Inclusion Criteria:

* Aged ≤ 12 years old (reported)
* HIV-1 positive (for example, two rapid HIV-1 antibody tests for children \>18 months and not breastfeeding, or one HIV-1 DNA/RNA test for children ≤18 months or who are breastfeeding)
* Not currently receiving antiretroviral therapy (history of pMTCT does not affect eligibility)
* Eligible to receive ART, according to current WHO guidelines
* Caregiver plans to reside in study catchment area for at least 6 months (reported)
* Caregiver provides sufficient locator information

Exclusion Criteria:

* Suspected meningitis, any other central nervous system infection, or encephalitis
B: Inclusion Criteria:

* HIV-infected (1x rapid HIV test positive)
* Considered TB suspect by attending doctor (must comprise at least 1 of the following: current fever or cough, drenching night sweats, self-reported LOW)
* Illness severity sufficient to warrant hospitalization
* ≥18 years old
* Provision of informed consent

Exclusion Criteria:

* HIV-uninfected
* Patients receiving any anti-TB medication in the 60 days prior to testing
* Unable to provide 30mls urine
* Inability to provide informed consent
C: Inclusion Criteria:

* English or Zulu speaking
* presenting for screening at mobile unit
* voluntarily undergoing HIV testing
* able and willing to give informed consent
* willing to share HIV and TB test results
* willing to attend one of six local clinics for treatment
* access to a mobile phone

Exclusion Criteria:

* pregnant
D: Inclusion Criteria:

* HIV-positive
* 18 years and above
* Able to give informed consent
* Admitted at the wards attached to the research site ART/HIV-clinic
* Eligible for LF-LAM testing (defined by WHO in the LF-LAM policy update 2019): CD4-cell-count ≤200 cells/μL (the last measured CD4-cell-count); or a WHO clinical stage 3 or 4 event at presentation for care; or seriously ill defined by WHO (respiratory rate \> 30/min, temperature \> 39°C, heart rate \> 120/min or unable to walk unaided); or a positive WHO TB symptom screening including one of the following symptoms: current cough, fever, weight loss, or night sweats

Exclusion Criteria:

* Anti-tuberculous treatment including preventive treatment with Isoniazide within the last 60 days
* Earlier participation in the same study

Answer: A