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NCT00099359 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

Completed
Registry status
Phase 3
Development phase
1,735
Enrollment target

NCT00099359 is a Phase 3 study that has completed, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 1,735 participants.

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The verdict

NCT00099359, a Phase 3 study, has completed, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

COMPLETED
Registry status
Phase 3
Development phase
1,735 participants
Enrollment target

Study Summary

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.

Interventions

  • DRUG Zidovudine
  • DRUG Nevirapine (NVP)
  • DRUG Epivir (3TC)
  • DRUG Nelfinavir (NFV)

Trial Details

FieldValue
Enrollment Target 1,735 participants
Start Date 2004-02
Est. Completion 2011-02
Phase Phase 3

What the Registry Record Tells You About NCT00099359

The ClinicalTrials.gov registry entry for NCT00099359 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,735 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Zidovudine is the first listed.

NCT00099359 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00099359 about?

NCT00099359 is a clinical study titled "Trial of Three Neonatal Antiretroviral Regimens for Prevention of Intrapartum HIV Transmission". 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 bab...

What is the current status of trial NCT00099359?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,735 participants. The study started on 2004-02. Estimated completion is 2011-02.

What interventions are being tested in trial NCT00099359?

The interventions under investigation include: Zidovudine (DRUG), Nevirapine (NVP) (DRUG), Epivir (3TC) (DRUG), Nelfinavir (NFV) (DRUG).

Who is sponsoring clinical trial NCT00099359?

This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.