Trial of Three Neonatal Antiretroviral Regimens for Prevention of Intrapartum HIV Transmission

Completed · Phase 3

Conditions studied: Disease Transmission, Vertical, Vertical Human Immunodeficiency Virus Transmission, HIV Infections

In brief

Giving anti-HIV medications to babies born of HIV positive mothers right after birth can lower the babies' risk of contracting HIV. This study will assess the safety and efficacy of two different combinations of anti-HIV medications compared to a one drug standard regimen in preventing mother to baby transmission. The one drug standard treatment and two combinations to be studied are: 1) zidovudine, 2) zidovudine/nevirapine and 3) zidovudine/lamivudine/nelfinavir.

Key facts

Study ID: NCT00099359
Run by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
People needed: 1735
Starts: 2004-02-01
Expected to finish: 2011-02-01
Last updated by the study team: 2012-12-04

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Miller Children's Hospital — Long Beach, California, United States
University of FL — Gainesville, Florida, United States
University of FL-HSC — Jacksonville, Florida, United States
University Medical and Dental School of NJ-Newark Campus — Newark, New Jersey, United States
Texas Childrens Hospital — Houston, Texas, United States
Hospital I. G. A. Dr. Diego Paroissien — Buenos Aires, Argentina
Federal University of Minas Gerais (UFMG) — Belo Horizonte, Minas Gerais, Brazil
Universidade de Sao Paulo (USP) , MD — São Paulo, Ribeirão Preto, Brazil
Hospital Fêmina S.A. Unidade Perinatal de Transmissão Vertical — Porto Alegre, Rio Grande do Sul, Brazil
Hospital Santa Casa (HSC) — Porto Alegre, Rio Grande do Sul, Brazil
Hospital Nossa Senhora da Conceicao (GHC) — Porto Alegre, Rio Grande do Sul, Brazil
Hospital dos Servidores do Estado (HSE) — Rio de Janeiro, Brazil
Hospital Geral de Novo Iguacu — Rio de Janeiro, Brazil
5088 - Universidade Federal de Sao Paulo (UFSP) — São Paulo, Brazil
San Juan Hospital — San Juan, Puerto Rico
Tygerberg Hospital — Cape Town, South Africa
Chris Hani Baragwanath Hospital — Johannesburg, South Africa

Full record on ClinicalTrials.gov

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