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NCT00099359 · ClinicalTrials.gov registry record · Phase 3
Trial of Three Neonatal Antiretroviral Regimens for Prevention of Intrapartum HIV Transmission
A Phase 3 study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Completed
- Registry status
- Phase 3
- Development phase
- 1,735
- Enrollment target
NCT00099359: Completed Phase 3 study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
NCT00099359 is a Phase 3 study that has completed, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 1,735 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (125% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00099359, a Phase 3 study, has completed, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,735 participants
- Enrollment target
Study Summary
Giving anti-HIV medications to babies born of HIV positive mothers right after birth can lower the babies' risk of contracting HIV. This study will assess the safety and efficacy of two different combinations of anti-HIV medications compared to a one drug standard regimen in preventing mother to baby transmission. The one drug standard treatment and two combinations to be studied are: 1) zidovudine, 2) zidovudine/nevirapine and 3) zidovudine/lamivudine/nelfinavir.
Primary Outcome
Intrapartum HIV infection at 3 Months
Interventions
- DRUG Zidovudine
- DRUG Nevirapine (NVP)
- DRUG Epivir (3TC)
- DRUG Nelfinavir (NFV)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,735 participants |
| Start Date | 2004-02 |
| Est. Completion | 2011-02 |
| Phase | Phase 3 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
What the finished NCT00099359 record still lists
NCT00099359 is an interventional study that assigns participants to a tested intervention. Its 1,735 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (125% higher).
The record links to 0 conditions, and to 4 interventions - of which Zidovudine is the first listed.
NCT00099359 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00099359 about?
NCT00099359 is a clinical study titled "Trial of Three Neonatal Antiretroviral Regimens for Prevention of Intrapartum HIV Transmission". Giving anti-HIV medications to babies born of HIV positive mothers right after birth can lower the babies' risk of contracting HIV. This study will assess the safety and efficacy of two different combinations of anti-HIV medications compared to a one drug standard regimen in preventing mother to bab...
What is the current status of trial NCT00099359?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,735 participants. The study started on 2004-02. Estimated completion is 2011-02.
What interventions are being tested in trial NCT00099359?
The interventions under investigation include: Zidovudine (DRUG), Nevirapine (NVP) (DRUG), Epivir (3TC) (DRUG), Nelfinavir (NFV) (DRUG).
Who is sponsoring clinical trial NCT00099359?
This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00099359's enrollment target sits among peer trials
1,735 130th of 2000 higher than 1,871 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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