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NCT00001007 · ClinicalTrials.gov registry record · Phase 1

A Study of Zidovudine in Infants Exposed to the HIV Before or Soon After Birth

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

Completed
Registry status
Phase 1
Development phase
18
Enrollment target
6
Study locations

NCT00001007 is a Phase 1 study of HIV Infections that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 18 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (96% lower). The trial reports 6 study locations across 5 states.

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The verdict

NCT00001007, a Phase 1 study of HIV Infections, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
18 participants
Enrollment target
6
Study locations

Study Summary

To determine if intravenous (IV) and oral zidovudine (AZT) can be safely given to children aged 1 day to 3 months who were born to mothers with an HIV infection. Also to determine the correct dose of AZT for young children. Of a total of 908 pediatric AIDS cases, 78 percent have acquired HIV infection from a mother with HIV infection or at high risk for acquisition of HIV, and the number of cases in children is expected to increase over the next several years. AZT therapy may be effective in altering the course of the disease and decreasing the high mortality in these children. It is also possible that early intervention with AZT may prevent the establishment of HIV contracted before, during, or just after birth.

Conditions Studied

HIV Infections

Interventions

  • DRUG Zidovudine

Study Locations (6)

Maryland

  • Johns Hopkins Hosp - Pediatric - Baltimore
  • Johns Hopkins Hosp - Baltimore

Alabama

  • Univ of Alabama at Birmingham - Birmingham

California

  • Stanford Univ School of Medicine - Stanford

Massachusetts

  • Boston Med Ctr - Boston

North Carolina

  • Duke Univ Med Ctr - Durham

Trial Details

FieldValue
Enrollment Target 18 participants
Phase Phase 1

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

2,006 total trials

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What the Registry Record Tells You About NCT00001007

The ClinicalTrials.gov registry entry for NCT00001007 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (96% lower). 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 1 intervention - of which Zidovudine is the first listed.

NCT00001007 reports 6 study locations spanning 5 distinct geographic areas - top geographies include Maryland, Alabama, California.

Frequently Asked Questions

What is clinical trial NCT00001007 about?

NCT00001007 is a clinical study titled "A Study of Zidovudine in Infants Exposed to the HIV Before or Soon After Birth". To determine if intravenous (IV) and oral zidovudine (AZT) can be safely given to children aged 1 day to 3 months who were born to mothers with an HIV infection. Also to determine the correct dose of AZT for young children. Of a total of 908 pediatric AIDS cases, 78 percent have acquired HIV infecti...

What is the current status of trial NCT00001007?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants.

What conditions does trial NCT00001007 study?

This clinical trial studies the following conditions: HIV Infections.

What interventions are being tested in trial NCT00001007?

The interventions under investigation include: Zidovudine (DRUG).

Who is sponsoring clinical trial NCT00001007?

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 NCT00001007 being conducted?

This trial has 6 study locations across Alabama, California, Maryland, Massachusetts, 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.