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NCT00000839 · ClinicalTrials.gov registry record · Phase 1
A Phase I Trial to Evaluate Didanosine (ddI) 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
- 12
- Enrollment target
NCT00000839: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00000839 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00000839, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
To assess the pharmacokinetics, safety, and toxicity of intravenous and oral didanosine (ddI) administration in third trimester pregnant women who are HIV positive but are either intolerant or resistant to zidovudine (AZT). To collect data on infant toxicity following maternal treatment with ddI during the third trimester of pregnancy. AZT may not be the optimal antiretroviral agent for all pregnant women requiring therapy for HIV infection. Although ddI has been approved for use in HIV-infected adults and older children, the safety and pharmacokinetics of ddI in pregnant women has not yet been determined.
Interventions
- DRUG Didanosine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Est. Completion | 2001-06 |
| Phase | Phase 1 |
What the finished NCT00000839 record still lists
NCT00000839 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which Didanosine is the first listed.
NCT00000839 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00000839 about?
NCT00000839 is a clinical study titled "A Phase I Trial to Evaluate Didanosine (ddI) in HIV-Infected Pregnant Women". To assess the pharmacokinetics, safety, and toxicity of intravenous and oral didanosine (ddI) administration in third trimester pregnant women who are HIV positive but are either intolerant or resistant to zidovudine (AZT). To collect data on infant toxicity following maternal treatment with ddI dur...
What is the current status of trial NCT00000839?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. Estimated completion is 2001-06.
What interventions are being tested in trial NCT00000839?
The interventions under investigation include: Didanosine (DRUG).
Who is sponsoring clinical trial NCT00000839?
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 NCT00000839's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 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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