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NCT00017719 · ClinicalTrials.gov registry record · Phase 3

Combination Treatment With and Without Protease Inhibitors for Women Who Begin Therapy for HIV Infection During Pregnancy

A Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 3
Development phase
440
Enrollment target

NCT00017719: Completed Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT00017719 is a Phase 3 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 440 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00017719, a Phase 3 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 3
Development phase
440 participants
Enrollment target

Study Summary

The best anti-HIV treatment regimen for pregnant women is not known. Protease inhibitors (PIs) are often used, but they have side effects that may be harmful for pregnant women. It is not known if treatment regimens that do not include PIs are as effective in pregnant women as those that include PIs. This trial will compare two anti-HIV treatment plans, one with and one without PIs, in women who start HIV treatment during pregnancy. The study will evaluate the effects of the anti-HIV drugs on the developing infant and prevention of mother-to-child HIV transmission during pregnancy.

Interventions

  • DRUG Zidovudine
  • DRUG Lamivudine
  • DRUG Nelfinavir mesylate
  • DRUG Nevirapine
  • DRUG Lamivudine/Zidovudine

Trial Details

FieldValue
Enrollment Target 440 participants
Start Date 2002-05
Est. Completion 2006-03
Phase Phase 3

What the finished NCT00017719 record still lists

NCT00017719 is an interventional study that assigns participants to a tested intervention. The registered 440 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (43% lower).

The record links to 0 conditions, and to 5 interventions - of which Zidovudine is the first listed.

NCT00017719 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00017719 about?

NCT00017719 is a clinical study titled "Combination Treatment With and Without Protease Inhibitors for Women Who Begin Therapy for HIV Infection During Pregnancy". The best anti-HIV treatment regimen for pregnant women is not known. Protease inhibitors (PIs) are often used, but they have side effects that may be harmful for pregnant women. It is not known if treatment regimens that do not include PIs are as effective in pregnant women as those that include PIs...

What is the current status of trial NCT00017719?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 440 participants. The study started on 2002-05. Estimated completion is 2006-03.

What interventions are being tested in trial NCT00017719?

The interventions under investigation include: Zidovudine (DRUG), Lamivudine (DRUG), Nelfinavir mesylate (DRUG), Nevirapine (DRUG), Lamivudine/Zidovudine (DRUG).

Who is sponsoring clinical trial NCT00017719?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00017719's enrollment target sits among peer trials

440 867th of 2000 higher than 1,129 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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Source: ClinicalTrials.gov NCT00017719, the US trial registry maintained by the National Library of Medicine. NCT00017719 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.