findmyKOL
Clinical trialNCT00099359CompletedPhase 3Interventional

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

SponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Enrollment1,735Disease Transmission, VerticalHIV InfectionsVertical Human Immunodeficiency Virus Transmission
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

17 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Argentina
  • Hospital I. G. A. Dr. Diego Paroissien

    Buenos Aires, Argentina

Brazil
  • 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 Nossa Senhora Da Conceicao (ghc)

    Porto Alegre, Rio Grande do Sul, Brazil

  • Hospital Santa Casa (hsc)

    Porto Alegre, Rio Grande do Sul, Brazil

  • Hospital Geral de Novo Iguacu

    Rio de Janeiro, Brazil

  • Hospital Dos Servidores Do Estado (hse)

    Rio de Janeiro, Brazil

  • 5088 - Universidade Federal de Sao Paulo (ufsp)

    São Paulo, Brazil

Puerto Rico
  • San Juan Hospital

    San Juan, Puerto Rico

South Africa
  • Tygerberg Hospital

    Cape Town, South Africa

  • Chris Hani Baragwanath Hospital

    Johannesburg, South Africa

United States
  • 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

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

EpivirNelfinavir →Nevirapine →Zidovudine →
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
29 Feb 2004
Primary completion
28 Feb 2011
Completion
28 Feb 2011
Last update posted
4 Dec 2012
Registered enrollment
1,735
Registry id
NCT00099359
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.