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Design of Completed Perinatal Trials 3d to 1 wk 36 wks 14 wks 6 wks IP 076 Thai (Harvard) Thai (Harvard), BMS IvC (ANRS), PETRA, Thai (Harvard) Thai (CDC), IvC (CDC) PETRA, 012, SAINT Wade (observational) PETRA AP PP (baby, mother or both) Thai (Harvard) 28 wks NonBF NonBF NonBF NonBF BF/NonBF NonBF/BF BF BF NonBF

Design of Completed Perinatal Trials 3d to 1 wk 36 wks 14 wks 6 wks IP 076 Thai (Harvard) Thai (Harvard), BMS IvC (ANRS), PETRA, Thai (Harvard) Thai (CDC),

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Page 1: Design of Completed Perinatal Trials 3d to 1 wk 36 wks 14 wks 6 wks IP 076 Thai (Harvard) Thai (Harvard), BMS IvC (ANRS), PETRA, Thai (Harvard) Thai (CDC),

Design of Completed Perinatal Trials

3d to1 wk

36 wks

14wks

6 wks

IP

076

Thai (Harvard)

Thai (Harvard), BMS

IvC (ANRS), PETRA, Thai (Harvard)

Thai (CDC), IvC (CDC)

PETRA, 012, SAINT

Wade (observational)

PETRA

AP PP (baby, mother or both)

Thai (Harvard)

28wks

NonBF

NonBF

NonBF

NonBF

BF/NonBF

NonBF/BF

BF

BF

NonBF

Page 2: Design of Completed Perinatal Trials 3d to 1 wk 36 wks 14 wks 6 wks IP 076 Thai (Harvard) Thai (Harvard), BMS IvC (ANRS), PETRA, Thai (Harvard) Thai (CDC),

Design of Ongoing/Planned Infant Prophylaxis Trials

4 wks

36 wks

6 wks

IP

Botswana (Harvard)

Ethiopia/India

Thai (CDC)

Ivory Coast (ANSR)

AP PP infant

HPTN 046

34 wks 3d

1 wk

6 mo

SIMBAAZT +/- NVPx1

AZT/DDI + NVP vs 3TC

PP infant regimen

NVP (daily) vs NVPx1

NVP(daily) vs NVPx1

AZT + NVPx1

AZT + NVPx1

Thai (Harvard)/AZT +/- NVPx1

Zambia (Harvard) South AfricaHIVNET 024UgandaZambia (UAB/PAF)/HPTN 054

NVPx1+EBF abrupt vs routine wean;NVPx1+EBFNVPx1 + AP/IP antiobiotics vs no antibioticsNVPx1 vs NVPx1 + HIVIG +/- VCT NVPx1

NICHD/HPTN 040(Brazil) AZT vs NPV;AZT vs AZT + NVPx3 vs AZT + 3TC/NFV 2wk

Malawi NVPx1 vs NVPx1 + AZT

Page 3: Design of Completed Perinatal Trials 3d to 1 wk 36 wks 14 wks 6 wks IP 076 Thai (Harvard) Thai (Harvard), BMS IvC (ANRS), PETRA, Thai (Harvard) Thai (CDC),

Design of Maternal HAART Prophylaxis Trials

36 wks

6 mos

IP

Botswana (Harvard)

AP PP Mother ?? wks

?? mo

Malawi (CDC/UNC)

Cameroon (EGPAF)

MTCT-Plus

Kenya (CDC)

Multisite Africa(WHO)

PP maternal

regimen

AZT/3TC/NVP?

AZT/3TC/NFV (?) vs NVP infant x 6 mos vs NVPx1 + nutrition

HAART x 6 months

AP if CD4> 200: AZT VS HAART;IP: ZDV vs HAARTPP: NO ARV vs HAART

HAART during BF

AZT/3TC/NFV?