Study Design

 The BAN study assesses two interventions for the prevention of mother-to-child HIV transmission during breastfeeding: a maternal nutritional intervention and maternal and infant ARV intervention.

Nutritional Intervention

Composition of maternal nutritional supplement

(100% of all recommended micronutrients except Vitamin A)

  • Energy 700 kcal
  • Protein 20 g
  • Iron 15 mg
  • Zinc 19 mg
  • Phosphorus 1200 mg
  • Selenium 75 mg
  • B1 (thiamin)1.6 mg
  • B2 (riboflavin) 1.8 mg
  • B3 (niacin) 20 mg equiv
  • B6 (pyridoxine) 2.2 mg
  • B12 (cyanocobalamine) 2.6 mg
  • C (ascorbic acid) 100 mg
  • E (a-tocopherol) 12 mg
  • Folic acid 300 mg
  • Iodine 200 mg

Antiretroviral Intervention

Maternal

AZT/3TC/ NVP*

AZT toxicity → D4T

NVP  toxicity → Nelfinavir**

Infant

NVP

NVP toxicity → 3TC

  *On February 7, 2005 NVP was discontinued as part of maternal HAART regimen and was replaced with Nelfinavir
**On January 25, 2006 Nelfinavir was replaced with Kaletra

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

The two interventions will be assessed in a factorial design: a 2-arm maternal nutritional intervention to promote maternal health, and a 3-arm antiretroviral intervention—with drugs given to the mother, the infant, or neither—to prevent HIV transmission during breastfeeding. The third arm of the antiretroviral intervention, in which neither mother nor infant receives drugs, was stopped based on recommendations of a Data and Safety Monitoring Board (DSMB) review of interim analysis in March 2008 after 78% participants had received treatment assignment.

The study’s target sample size is 2418 mother-infant pairs receiving both interventions. Before discontinuing the "no ARV" arms, there were 6 conditions to which an enrolled mother-infant pair was assigned:

  No ARV Infant ARV Mother ARV
No nutritional supplement 403 no supp, no ARV 403 no supp, infant ARV 403 no supp, mother ARV
Nutritional supplement 403 supp, no ARV  403 supp, infant ARV 403 supp, mother ARV

 

 

 

Since the third arm of the antiretroviral intervention was stopped, there are now 4 conditions to which an enrolled mother-infant pair may be assigned for the duration of the trial:

  Infant ARV Mother ARV
No nutritional supplement 403 no supp, infant ARV 403 no supp, mother ARV
Nutritional supplement 403 supp, infant ARV 403 supp, mother ARV

 

In addition to the two interventions, study participants received the following:

  • Tetanus toxoid Cotrimoxizole prophylaxis (June 2006 – mothers with CD4 < 500; infants from 6 weeks to 36 weeks if DNA negative)
  • Pediatric Vaccines
    • BCG at birth
    • Polio at birth, 6 weeks
    • DPT-HepB + Hib at 6, 10, 14 weeks
    • measles at 9 months
  • antenatal vitamins, including iron
  • family maize supplement (2 kg/week)
  • weaning food from 24 to 48 weeks: powdered milk, peanut butter, sugar, oil (fortified with micronutrients) totaling 400 kcal and 9.5 g of protein per day
  • care for all intercurrent illnesses, including antibiotics (full microbiology laboratory available
  • mosquito nets (2007-2008 under Malawi Ministry of Health)
  • transport money ($2.00 USD, Apr 2004; $4.00 USD, Nov 2005; $5.00 USD, May 2008)