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

NCT00017719 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 440

Last updated 2021-11-01

No results posted yet for this 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.

Conditions

  • HIV Infections
  • Pregnancy

Interventions

DRUG

Lamivudine

DRUG

Lamivudine/Zidovudine

DRUG

Nelfinavir mesylate

DRUG

Nevirapine

DRUG

Zidovudine

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Jane Hitti, MD, MPH · Department of Obstetrics/Gynecology, University of Washington Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
14 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-05-31
Completion
2006-03-31

Countries

  • United States
  • Brazil
  • Puerto Rico
  • The Bahamas

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00017719 on ClinicalTrials.gov