Clinical trialNCT00017719CompletedPhase 3Interventional

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

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)Enrollment440HIV InfectionsPregnancy

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Jane Hitti, MD, MPH
Department of Obstetrics/Gynecology, University of Washington Medical Center
Study Chair
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

49 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Brazil

Som Federal University Minas Gerais Brazil Nichd Crs
Belo Horizonte, Minas Gerais, Brazil
Hosp. Dos Servidores Rio de Janeiro Nichd Crs
Rio de Janeiro, Brazil
Hosp. Dos Servidores Do Estado Crs
Rio de Janeiro, Brazil

Puerto Rico

San Juan City Hosp. Pr Nichd Crs
San Juan, Puerto Rico

The Bahamas

Princess Margaret Hosp. Bahamas Nichd Crs
Nassau, The Bahamas

United States

Usc la Nichd Crs
Los Angeles, California, United States
Ucsd Mother-Child-Adolescent Program Crs
San Diego, California, United States
Ucsf Pediatric Aids Crs
San Francisco, California, United States
Harbor - Ucla Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
Torrance, California, United States
Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
New Haven, Connecticut, United States
Howard Univ. Washington Dc Nichd Crs
Washington D.C., District of Columbia, United States
Univ. of Miami Miller School of Medicine - Jackson Memorial Hosp.
Miami, Florida, United States
Univ. of Miami Ped. Perinatal Hiv/aids Crs
Miami, Florida, United States
Med. College of Georgia School of Medicine, Dept. of Peds., Div. of Infectious Diseases
Augusta, Georgia, United States
Columbus Regional Healthcare System, the Med. Ctr.
Columbus, Georgia, United States
Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens Hiv Program
Chicago, Illinois, United States
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
Chicago, Illinois, United States
Tulane Univ. Health Science Ctr., Tulane Univ. Hosp. & Clinic
New Orleans, Louisiana, United States
Tulane/lsu Maternal/child Crs
New Orleans, Louisiana, United States
Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
Baltimore, Maryland, United States
Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
Baltimore, Maryland, United States
Bmc, Div. of Ped Infectious Diseases
Boston, Massachusetts, United States
Brigham and Women'S Hosp., Div. of Infectious Disease
Boston, Massachusetts, United States
Hms - Children'S Hosp. Boston, Div. of Infectious Diseases
Boston, Massachusetts, United States
Baystate Health, Baystate Med. Ctr.
Springfield, Massachusetts, United States
Wne Maternal Pediatric Adolescent Aids Crs
Worcester, Massachusetts, United States
Children'S Hospital of Michigan Nichd Crs
Detroit, Michigan, United States
Univ. of Mississippi Med. Ctr Children'S Hosp.
Jackson, Michigan, United States
Rutgers - New Jersey Medical School Crs
Newark, New Jersey, United States
Columbia Impaact Crs
New York, New York, United States
Nyu Ny Nichd Crs
New York, New York, United States
Strong Memorial Hospital Rochester Ny Nichd Crs
Rochester, New York, United States
Suny Stony Brook Nichd Crs
Stony Brook, New York, United States
Suny Upstate Med. Univ., Dept. of Peds.
Syracuse, New York, United States
Bronx-Lebanon Hosp. Impaact Crs
The Bronx, New York, United States
Montefiore Med. Ctr. - Aecom
The Bronx, New York, United States
Dumc Ped. Crs
Durham, North Carolina, United States
Univ. of Cincinnati Crs
Cincinnati, Ohio, United States
Case Crs
Cleveland, Ohio, United States
Metrohealth Crs
Cleveland, Ohio, United States

9 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Lamivudine →Nelfinavir →Nevirapine →Zidovudine →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 May 2002
Primary completion: —
Completion: 31 Mar 2006
Last update posted: 1 Nov 2021
Registered enrollment: 440
Registry id: NCT00017719

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.