Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomised Controlled Trial of n-3 Polyunsaturated Fatty Acid-Enriched Therapeutic Food for Childhood Severe Malnutrition
Brief Summary: The investigators will perform a randomised controlled trial of the provision of food designed for rehabilitation of malnourished children that is supplemented with n-3 fatty acids compared to usual composition. The investigators want to see whether the provision of such a food normalises the deficiencies in essential fatty acids observed in severely malnourished children faster than standard composition.


Options:
A: Inclusion Criteria:

* Aged 5 years or older
* Documented HIV infection by HIV ELISA or HIV rapid test
* Naive to ART
* CD4 T-cell count \<100 cells/mm3 on blood test taken at screening for REALITY
* Results of screening haematology and biochemistry tests available and no contraindications to planned ART according to national guidelines
* Patient/carer provide informed consent (and children \<18 years assent, as appropriate according to their age and knowledge of HIV status)

The lower age limit is because CD4 counts are less reliable predictors of immunodeficiency under 5 years: CD4 counts are recommended by guidelines in older children.

No patient with a CD4 count above 100 cells/mm3 should have ART delayed in order to subsequently meet eligibility criteria. Rather, patients eligible for REALITY will be those testing HIV positive for the first time with a low CD4 count (i.e. those delaying presentation to care), or those who have defaulted before initiating ART and only return to care at an advanced stage of immuno-deficiency.

Exclusion Criteria:

* Contraindications to any proposed antiretroviral drugs (including integrase inhibitors), isoniazid, fluconazole, albendazole or azithromycin
* Pregnant or breastfeeding or intending to become pregnant during the first 12 weeks of the study
* Ever known to have previously received single-dose nevirapine for prevention of mother-to-child transmission (mother or child).
B: Inclusion Criteria:

* Children aged 6 months to 5 years old
* Provision of informed consent
* Severe malnutrition (one or more of mid-upper arm circumference \<11.5cm, weight for height z score \<-3, or nutritional oedema)
* Stabilised and eligible to receive RUTF according to national guidelines

Exclusion Criteria:

* Known HIV disease, tuberculosis or other chronic infection\*
* Known allergy or hypersensitivity to any of the product ingredients

  * Chronic infections such as HIV and tuberculosis and their treatments are likely to cause alterations in lipid metabolism that may confound interpretation of this pilot trial. national guidelines recommend offering provider-initiated testing for HIV for all severely malnourished children, and referral for comprehensive care in the case of a positive test.
C: Inclusion Criteria:

* Age 6 to 59 months
* SAM, defined as Weight for height less than -3 SD of WHO standard or oedema of both feet or both.

Exclusion Criteria:

* Complicated SAM defined as child with SAM having signs of severe illness requiring hospitalization
* Known allergy to animal milk or peanuts
* Likely to leave the study area permanently in the next 16 weeks
D: Inclusion Criteria:

* signed informed consent from at least one guardian
* age 6.00 months to 14.99 months
* weight-for-age \<-2.0 Z scores
* availability during the period of the study.
* permanent resident Lungwena Health Centre catchment area

Exclusion Criteria:

* moderate or severe wasting (WHM\<80% of the reference median)
* history of peanut allergy
* history of any serious allergic reaction to any substance, requiring emergency medical care
* history of anaphylaxis
* severe illness warranting hospital referral
* concurrent participation in another clinical trial with intervention to the child

Answer: B