The aim of the study is to find short course alternatives to single dose (sd)nevirapine for the prevention of mother-to-child HIV-transmission with the same or better degree of transmission protection than sd nevirapine but with less NNRTI resistance development.
Randomised open study comparing Zidovudine from 28 weeks gestation, single dose Nevirapine + 1 week of Combivir with Zidovudine from 28 weeks gestation, single dose Nevirapine + single dose of Truvada for the mothers during birth. In both arms the infants will receive one dose of nevirapine within the first days after births as well as 7 to 28 days Zidovudine. N = 450. The study will be conducted at Ngamiani and Makorora Health Centres and Bombo Regional Hospital in Tanga, Tanzania as a cooperation between Rigshospitalet, Denmark, University of Copenhagen and National Institute of Medical Research, Tanzania.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
566
Bombo Regional Hospital
Tanga, Tanzania
frequency of mother-to-child HIV transmission
Time frame: 6 weeks post partum
frequency of NNRTI resistance development
Time frame: 6 weeks post partum
Comparison of p24 antigen to HIV RNA for treatment induced changes in viremia
Time frame: Delivery, day 7, day 42 and month 9 post partum
Comparison of p24 antigen ability to detect viremia for the various subtypes A,C & D
Time frame: Delivery, Day 7, Day 42 post partum, mother, Day 42 and Day 90 post partum child
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