1,735
Participants
Start Date
February 29, 2004
Primary Completion Date
February 28, 2011
Study Completion Date
February 28, 2011
Zidovudine
Given for 6 weeks. 12mg PO BID if birthweight (BW) \> 2000 grams 8 mg PO BID if BW \< 2000 grams
Nevirapine (NVP)
"Standard of Care (Zidovudine) plus~NVP, first dose initiated within 48 hrs of birth, second dose 48 hrs (+ 4 hours) after the first dose, and third dose 96 hours (+ 4 hours) after the second dose :~12 mg PO per dose if BW \> 2000 grams, 8 mg PO per dose if BW \< 2000 grams"
Epivir (3TC)
"Stand of care (Zidovudine) plus~3TC, given for 2 weeks: 6 mg po bid if BW \> 2000 grams 4 mg po bid if BW \< 2000 grams AND~NFV, given for 2 weeks:~200 mg po bid if BW \> 3000 grams 150 mg po bid if BW \> 2,000 - 3000 grams 100 mg PO BID if BW \< 2000 grams"
Nelfinavir (NFV)
200 mg BID if birth weight (BW) \> 3000 grams for 2 weeks;150 mg BID if BW \> 2000-3000 grams for 2 weeks; 100 mg BID BW \</= 2000 grams for 2 weeks
University of FL-HSC, Jacksonville
Texas Childrens Hospital, Houston
Miller Children's Hospital, Long Beach
Hospital Fêmina S.A. Unidade Perinatal de Transmissão Vertical, Porto Alegre
University of FL, Gainesville
University Medical and Dental School of NJ-Newark Campus, Newark
Hospital I. G. A. Dr. Diego Paroissien, Buenos Aires
Tygerberg Hospital, Cape Town
Chris Hani Baragwanath Hospital, Johannesburg
Federal University of Minas Gerais (UFMG), Belo Horizonte
Universidade de Sao Paulo (USP) , MD, São Paulo
Hospital Santa Casa (HSC), Porto Alegre
Hospital Nossa Senhora da Conceicao (GHC), Porto Alegre
Hospital dos Servidores do Estado (HSE), Rio de Janeiro
Hospital Geral de Novo Iguacu, Rio de Janeiro
5088 - Universidade Federal de Sao Paulo (UFSP), São Paulo
San Juan Hospital, San Juan
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH