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

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. According to ClinicalTrials.gov, the official US trial registry.

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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

HIV Infections

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
National Institute of Allergy and Infectious Diseases (NIAID)

2,006 total trials

What the finished NCT00006396 record still lists

NCT00006396 is an interventional study that assigns participants to a tested intervention. Its 1,500 participants enrollment target places it among the larger protocols in the corpus, above the 443-participant average among 542 other HIV Infections trials with a reported enrollment target (239% higher).

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 a single indexed study location in 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.

Learn More About Clinical Trials

Similar trials for HIV Infections

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00006396's enrollment target sits among peer trials

1,500 17th of 542 higher than 525 of 542 other HIV Infections trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other HIV Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT00006396, the US trial registry maintained by the National Library of Medicine. NCT00006396 (large enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.