Please select the arm or intervention descriptions that belong 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: Intervention Type: OTHER; Name: Development of a diagnosis algorithm; Assigned to Arm(s): N/A
B: Arm Label: Urgent ART; Type: EXPERIMENTAL; Interventions: Other: Urgent ART | Arm Label: Early ART; Type: ACTIVE_COMPARATOR; Interventions: Other: Early ART | Intervention Type: OTHER; Name: Urgent ART; Assigned to Arm(s): Urgent ART | Intervention Type: OTHER; Name: Early ART; Assigned to Arm(s): Early ART
C: Arm Label: LAM plus standard care; Type: EXPERIMENTAL; Interventions: Device: Urine LAM strip test | Arm Label: Standard care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DEVICE; Name: Urine LAM strip test; Assigned to Arm(s): LAM plus standard care
D: Arm Label: Investigational Vaccine; Type: EXPERIMENTAL; Interventions: Biological: MVA85A/AERAS-485 | Arm Label: Control Group; Type: PLACEBO_COMPARATOR; Interventions: Biological: Candida Skin Test Antigen | Intervention Type: BIOLOGICAL; Name: MVA85A/AERAS-485; Assigned to Arm(s): Investigational Vaccine | Intervention Type: BIOLOGICAL; Name: Candida Skin Test Antigen; Assigned to Arm(s): Control Group

Answer: B