CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed
Drug / intervention
Lamivudine +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00017719
NCT00017719Phase 3Completed

Randomized Trial of Protease Inhibitor-Including vs. Protease Inhibitor-Sparing Regimens for Women Who Initiate Therapy of HIV Infection During Pregnancy

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Aug 31, 2001·Updated Nov 1, 2021

In Brief

A Phase 3 clinical trial evaluating Lamivudine, Lamivudine/Zidovudine, and 3 other interventions for HIV Infections and Pregnancy. Completed, across 49 sites in 4 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil, Puerto Rico, The Bahamas, United States

Timeline

Phase 3CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 31, 2001
Enrollment StartMay 1, 2002
Study CompletionMar 1, 2006
TodayJul 2, 2026
Posted 24.8 years ago

Interventions

Lamivudinedrug

Lamivudine/Zidovudinedrug

Nelfinavir mesylatedrug

Nevirapinedrug

Zidovudinedrug