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NCT00006396 · ClinicalTrials.gov registry record · Phase 3

Effectiveness of AZT and Nevirapine in Preventing HIV Transmission From Ugandan Mothers to Their Newborns

A Phase 3 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 3
Development phase
1,500
Enrollment target
1
Study location

NCT00006396 is a Phase 3 study of HIV Infections that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 1,500 participants, above the 443-participant average among 542 other HIV Infections trials with a reported enrollment target (239% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT00006396, a Phase 3 study of HIV Infections, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 3
Development phase
1,500 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to see if nevirapine (NVP) or zidovudine (AZT), given to mothers during labor and delivery and to their babies during the first week of life, can reduce the rate of mothers passing HIV to their babies. About 25 percent of HIV-infected mothers pass HIV infection to their babies during labor and delivery. There is an urgent need to find a simpler way to prevent mother-to-infant transmission during labor and delivery. The proposed NVP schedule is simpler and possibly could be used in Uganda.

Conditions Studied

Interventions

  • DRUG Zidovudine
  • DRUG Nevirapine

Study Locations (1)

North Carolina

  • Missie Allen - Research Triangle Park

Trial Details

FieldValue
Enrollment Target 1,500 participants
Est. Completion 2004-11
Phase Phase 3

What the Registry Record Tells You About NCT00006396

The ClinicalTrials.gov registry entry for NCT00006396 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,500 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 443-participant average among 542 other HIV Infections trials with a reported enrollment target (239% higher). 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 1 condition, with HIV Infections appearing as the primary indexed condition, and to 2 interventions - of which Zidovudine is the first listed.

NCT00006396 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.

Frequently Asked Questions

What is clinical trial NCT00006396 about?

NCT00006396 is a clinical study titled "Effectiveness of AZT and Nevirapine in Preventing HIV Transmission From Ugandan Mothers to Their Newborns". The purpose of this study is to see if nevirapine (NVP) or zidovudine (AZT), given to mothers during labor and delivery and to their babies during the first week of life, can reduce the rate of mothers passing HIV to their babies. About 25 percent of HIV-infected mothers pass HIV infection to their...

What is the current status of trial NCT00006396?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,500 participants. Estimated completion is 2004-11.

What conditions does trial NCT00006396 study?

This clinical trial studies the following conditions: HIV Infections.

What interventions are being tested in trial NCT00006396?

The interventions under investigation include: Zidovudine (DRUG), Nevirapine (DRUG).

Who is sponsoring clinical trial NCT00006396?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00006396 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.