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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 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000862
The ClinicalTrials.gov registry entry for NCT00000862 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 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 Zidovudine is the first listed.
NCT00000862 reports 0 study locations.
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.
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