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NCT00076791 · ClinicalTrials.gov registry record · Phase 1
Safety of Tenofovir Disoproxil Fumarate (TDF) and Emtricitabine/TDF in HIV Infected Pregnant Women and Their Infants
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 66
- Enrollment target
NCT00076791: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00076791 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 66 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00076791, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 66 participants
- Enrollment target
Study Summary
Most infants infected with HIV through mother-to-child transmission (MTCT, or perinatal transmission) become infected during labor and delivery. The purpose of this study is to test the safety and tolerability of a single dose of tenofovir disoproxil fumarate (TDF) or emtricitabine/TDF (FTC/TDF) given at the time of labor to HIV infected pregnant women and to their newborn infants.
Interventions
- DRUG Tenofovir disoproxil fumarate
- DRUG Emtricitabine/Tenofovir disoproxil fumarate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2004-03 |
| Est. Completion | 2011-03 |
| Phase | Phase 1 |
What the finished NCT00076791 record still lists
NCT00076791 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% higher).
The record links to 0 conditions, and to 2 interventions - of which Tenofovir disoproxil fumarate is the first listed.
NCT00076791 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00076791 about?
NCT00076791 is a clinical study titled "Safety of Tenofovir Disoproxil Fumarate (TDF) and Emtricitabine/TDF in HIV Infected Pregnant Women and Their Infants". Most infants infected with HIV through mother-to-child transmission (MTCT, or perinatal transmission) become infected during labor and delivery. The purpose of this study is to test the safety and tolerability of a single dose of tenofovir disoproxil fumarate (TDF) or emtricitabine/TDF (FTC/TDF) giv...
What is the current status of trial NCT00076791?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 66 participants. The study started on 2004-03. Estimated completion is 2011-03.
What interventions are being tested in trial NCT00076791?
The interventions under investigation include: Tenofovir disoproxil fumarate (DRUG), Emtricitabine/Tenofovir disoproxil fumarate (DRUG).
Who is sponsoring clinical trial NCT00076791?
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 NCT00076791's enrollment target sits among peer trials
66 786th of 2000 higher than 1,203 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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