Impact of HAART during Pregnancy and Breastfeeding on MTCT of HIV and Mother’s Health: The Kesho Bora Study

 

To optimize the use of ARV drugs during the antepartum, intrapartum and postpartum periods to prevent MTCT of HIV and preserve the health of the mother in settings where the majority of HIV-infected women breastfeed

 

HIV-free infant survival at 6 weeks (in utero/intrapartum/early postpartum) and 12 months among all infants, irrespective of mode of infant feeding (intent-to-treat analysis)
HIV-free infant survival at 12 months among infants who received any breast milk
AIDS-free survival of mothers at 12 months following delivery
Incidence of serious adverse events in mothers
Estimate the rates of early and late postpartum transmission in ever breastfed infants, according to maternal HIV status and treatment received
Describe the correlates of infant HIV-free survival including stage of maternal HIV disease (clinical, immunological and virological factors), ARV prophylaxis and/or therapy given to the mother, and mode of infant feeding
Describe the correlates of mother’s HIV disease progression and survival including socio-demographic characteristics, disease and nutritional status at enrolment, ARV prophylaxis and/or therapy given to the mother, and mode of infant feeding
Identify immunological and virological determinants of residual HIV-1 transmission during breastfeeding (coordinated by P. Van de Perre through ANRS1271 programme)
Describe and compare the feasibility, acceptability, safety, tolerability of and adherence to the maternal ARV prophylaxis
Describe the feasibility and acceptability of current UNAIDS/UNICEF/WHO recommendations on HIV and infant feeding (coordinated by K. Simondon through ANRS1271 programme)
Assess the feasibility and safety of rapid weaning over a two week period with complete cessation of breastfeeding by 6 months of age, and assess nutritional status and growth of children up to two years of age (coordinated by K. Simondon through ANRS1271 programme)
Describe changes in viral load and emergence of viral resistance in blood and breast milk according to the maternal ARV prophylaxis and therapy regimens and immunological and virological status at enrolment
Describe the extent of partner involvement, family planning practices, condom use and sexual activity of couples
Describe and analyse the social and cultural factors that may increase or reduce HIV rates of transmission through breastfeeding (coordinated by A. Desclaux through ANRS1271 programme)
Describe family HIV-care needs and accessibility of HIV-care services
Assess the cost-effectiveness of the ARV prophylaxis and therapy regimens in preventing MTCT

 

This multicentre study is designed as a randomized controlled trial of eligible women with CD4+ cell counts between 200 and 500 cells/mm3. Elligible women with no contraindication and willing to be randomized will receive one of two different regimens for MTCT prevention: 1) A triple-ARV regimen (ZDV, 3TC and LPV/r) beginning at 34-36 weeks gestation, through delivery, until six months postpartum; or 2) A short-course regimen consisting of ZDV beginning at 34-36 weeks gestation until the onset of labour, plus one dose of ZDV and one dose of NVP at the onset of labour.

 

EXPECTED RESULTS
AIDS-free survival in mothers is defined as survival with no WHO HIV Stage 4 condition
HIV-free survival in infants and children is defined as being alive without HIV infection
Incidence of Serious Adverse Events