Trial of Three Neonatal Antiretroviral Regimens for Prevention of Intrapartum HIV Transmission
Disease Transmission, Vertical, Vertical Human Immunodeficiency Virus Transmission, HIV Infections
About this trial
This is an interventional prevention trial for Disease Transmission, Vertical focused on measuring HIV, Perinatal, Prevention, Transmission, Nevirapine, Epivir, Zidovudine, Nelfinavir, ZDV, NVP, 3TC, NFV, Viracept, Viramune, HIV Seronegativity, Treatment Naive
Eligibility Criteria
Inclusion Criteria: Infants who meet all of the following criteria are eligible for the study: Mother known to be HIV-1-infected prior to labor or identified at the time of labor or <48 hours postpartum. HIV-1 infection for the purposes of enrollment into this study is defined as: (a) Single positive HIV-1 rapid test in mother or her infant; or (b) Historical documentation of a positive HIV-1 diagnostic test confirmed by repeat diagnostic testing for HIV-1 according to country guidelines in mother (written documentation of test results must be present in the medical record). Maternal written informed consent for study participation. Mother has not received any antiretroviral therapy during the current pregnancy prior to the onset of labor and delivery; women may have received intravenous or oral ZDV during labor. Women may have received any antiretroviral therapy in previous pregnancies for prevention of vertical HIV-1 transmission. Infant is <48 hours old. Infant may have received up to 48 hours of ZDV as standard care before study enrollment. Exclusion Criteria: Infants who meet any of the following criteria will be excluded from the study: Extreme prematurity (< 32 weeks of gestation). Birth weight <1500 grams. Presence of life-threatening conditions. Inability to take oral medication throughout the first 48 hours of life (must be able to receive oral medication by age 48 hours). Maternal inability to provide informed consent because of a lack of a conscious state, psychiatric conditions, or language barriers. Mother received any antiretroviral therapy during labor and delivery other than intravenous or oral ZDV.
Sites / Locations
- Miller Children's Hospital
- University of FL
- University of FL-HSC
- University Medical and Dental School of NJ-Newark Campus
- Texas Childrens Hospital
- Hospital I. G. A. Dr. Diego Paroissien
- Federal University of Minas Gerais (UFMG)
- Universidade de Sao Paulo (USP) , MD
- Hospital Fêmina S.A. Unidade Perinatal de Transmissão Vertical
- Hospital Santa Casa (HSC)
- Hospital Nossa Senhora da Conceicao (GHC)
- Hospital dos Servidores do Estado (HSE)
- Hospital Geral de Novo Iguacu
- 5088 - Universidade Federal de Sao Paulo (UFSP)
- San Juan Hospital
- Tygerberg Hospital
- Chris Hani Baragwanath Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
A
B
C
Standard of care ( Zidovudine only)
Standard of care (Zidovudine) plus Nevirapine
Standard of Care (Zidovudine) plus 2 weeks of Epivir and Nelfinavir