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NCT00000862 · ClinicalTrials.gov registry record · Phase 1
A Study of Zidovudine During Labor and Delivery in HIV-Infected Pregnant Women
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT00000862: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00000862 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00000862, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
To obtain a pharmacokinetic profile of oral ZDV and to determine whether the oral administration of Zidovudine (ZDV) during labor and delivery will provide a similar profile to that obtained with the use of IV ZDV in ACTG 082. To evaluate the tolerance of oral ZDV in this population, defined as the ability to take oral doses and lack of vomiting within 30 minutes of receiving oral study doses. The worldwide use of constant intrapartum ZDV infusions to prevent transmission is not practical or feasible. Approximately 18% of the women in the ACTG 076 trial missed their IV ZDV infusions, even at experienced ACTG sites. There is an urgent need to establish a more practical method of delivering ZDV during labor and delivery that, at minimum, will approximate the rate of ZDV administration utilized in ACTG 082. In the future, this would enable women to start an intensive ZDV regimen during early labor, even prior to reaching the hospital.
Interventions
- DRUG Zidovudine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Est. Completion | 2003-11 |
| Phase | Phase 1 |
What the finished NCT00000862 record still lists
NCT00000862 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 1 intervention - of which Zidovudine is the first listed.
NCT00000862 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00000862 about?
NCT00000862 is a clinical study titled "A Study of Zidovudine During Labor and Delivery in HIV-Infected Pregnant Women". To obtain a pharmacokinetic profile of oral ZDV and to determine whether the oral administration of Zidovudine (ZDV) during labor and delivery will provide a similar profile to that obtained with the use of IV ZDV in ACTG 082. To evaluate the tolerance of oral ZDV in this population, defined as the ...
What is the current status of trial NCT00000862?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. Estimated completion is 2003-11.
What interventions are being tested in trial NCT00000862?
The interventions under investigation include: Zidovudine (DRUG).
Who is sponsoring clinical trial NCT00000862?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00000862's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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