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NCT00006279 · ClinicalTrials.gov registry record · Phase 1

The Safety of Nevirapine When Given to Breast-Feeding Babies From Birth to Age 6 Months

A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 1
Development phase
75
Enrollment target

NCT00006279 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 75 participants.

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The verdict

NCT00006279, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
75 participants
Enrollment target

Study Summary

The purpose of this study is to see if it is safe to give nevirapine (NVP) to breast-feeding babies from birth to the age of 6 months and to determine what dose of NVP should be given. Breast-feeding has been shown to be very important for the physical and mental health of infants. This is especially true during the first 6 months of life. However, an HIV-positive mother can pass the virus on to her baby by breast-feeding. Because of this risk, HIV-positive mothers are encouraged to formula-feed, not breast-feed, their babies. In developing countries, however, some women cannot afford to formula-feed. If they do formula-feed, these women risk exposing their HIV status. These women have great need for methods that can lower the chance that they will pass HIV on to their babies. This study will test NVP as a way of doing this.

Interventions

  • DRUG Nevirapine

Trial Details

FieldValue
Enrollment Target 75 participants
Est. Completion 2005-05
Phase Phase 1

What the Registry Record Tells You About NCT00006279

The ClinicalTrials.gov registry entry for NCT00006279 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Nevirapine is the first listed.

NCT00006279 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00006279 about?

NCT00006279 is a clinical study titled "The Safety of Nevirapine When Given to Breast-Feeding Babies From Birth to Age 6 Months". The purpose of this study is to see if it is safe to give nevirapine (NVP) to breast-feeding babies from birth to the age of 6 months and to determine what dose of NVP should be given. Breast-feeding has been shown to be very important for the physical and mental health of infants. This is especial...

What is the current status of trial NCT00006279?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 75 participants. Estimated completion is 2005-05.

What interventions are being tested in trial NCT00006279?

The interventions under investigation include: Nevirapine (DRUG).

Who is sponsoring clinical trial NCT00006279?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 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.