Combination Treatment With and Without Protease Inhibitors for Women Who Begin Therapy for HIV Infection During Pregnancy
Public ClinicalTrials.gov record NCT00017719. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Randomized Trial of Protease Inhibitor-Including vs. Protease Inhibitor-Sparing Regimens for Women Who Initiate Therapy of HIV Infection During Pregnancy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT00017719
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 440 participants
Conditions and interventions
Conditions
Interventions
- Lamivudine Drug
- Lamivudine/Zidovudine Drug
- Nelfinavir mesylate Drug
- Nevirapine Drug
- Zidovudine Drug
Drug
Eligibility (public fields only)
- Age range
- 14 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 30, 2002
- Primary completion
- Not listed
- Completion
- Feb 28, 2006
- Last update posted
- Oct 31, 2021
2002 – 2006
United States locations
- U.S. sites
- 44
- U.S. states
- 18
- U.S. cities
- 31
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Usc La Nichd Crs | Los Angeles | California | 90033 | — |
| UCSD Mother-Child-Adolescent Program CRS | San Diego | California | 92103 | — |
| UCSF Pediatric AIDS CRS | San Francisco | California | — | — |
| Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases | Torrance | California | 90509 | — |
| Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease | New Haven | Connecticut | 06504 | — |
| Howard Univ. Washington DC NICHD CRS | Washington D.C. | District of Columbia | 20060 | — |
| Univ. of Miami Miller School of Medicine - Jackson Memorial Hosp. | Miami | Florida | 33136 | — |
| Univ. of Miami Ped. Perinatal HIV/AIDS CRS | Miami | Florida | 33161 | — |
| Med. College of Georgia School of Medicine, Dept. of Peds., Div. of Infectious Diseases | Augusta | Georgia | 30912 | — |
| Columbus Regional HealthCare System, The Med. Ctr. | Columbus | Georgia | 31901 | — |
| Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program | Chicago | Illinois | 60608 | — |
| Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease | Chicago | Illinois | 60637-1470 | — |
| Tulane Univ. Health Science Ctr., Tulane Univ. Hosp. & Clinic | New Orleans | Louisiana | 70112-2699 | — |
| Tulane/LSU Maternal/Child CRS | New Orleans | Louisiana | 70112-2699 | — |
| Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases | Baltimore | Maryland | 21287-4933 | — |
| Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology | Baltimore | Maryland | — | — |
| HMS - Children's Hosp. Boston, Div. of Infectious Diseases | Boston | Massachusetts | 02115 | — |
| BMC, Div. of Ped Infectious Diseases | Boston | Massachusetts | 02118 | — |
| Brigham and Women's Hosp., Div. of Infectious Disease | Boston | Massachusetts | 02478 | — |
| Baystate Health, Baystate Med. Ctr. | Springfield | Massachusetts | 01199 | — |
| WNE Maternal Pediatric Adolescent AIDS CRS | Worcester | Massachusetts | 01655 | — |
| Children's Hospital of Michigan NICHD CRS | Detroit | Michigan | 48201 | — |
| Univ. of Mississippi Med. Ctr Children's Hosp. | Jackson | Michigan | 39213 | — |
| Rutgers - New Jersey Medical School CRS | Newark | New Jersey | 07103 | — |
| Nyu Ny Nichd Crs | New York | New York | 10016 | — |
| Columbia IMPAACT CRS | New York | New York | 10032 | — |
| Strong Memorial Hospital Rochester NY NICHD CRS | Rochester | New York | 14642 | — |
| SUNY Stony Brook NICHD CRS | Stony Brook | New York | 11794 | — |
| SUNY Upstate Med. Univ., Dept. of Peds. | Syracuse | New York | 13210 | — |
| Bronx-Lebanon Hosp. IMPAACT CRS | The Bronx | New York | 10457 | — |
| Montefiore Med. Ctr. - AECOM | The Bronx | New York | 19461 | — |
| DUMC Ped. CRS | Durham | North Carolina | 27710 | — |
| Univ. of Cincinnati CRS | Cincinnati | Ohio | 45267 | — |
| Case CRS | Cleveland | Ohio | 44106 | — |
| MetroHealth CRS | Cleveland | Ohio | 44109-1998 | — |
| Oregon Health & Science Univ. - Dept. of Peds., Div. of Infectious Disease | Portland | Oregon | — | — |
| Regional Med. Ctr. at Memphis | Memphis | Tennessee | 38105 | — |
| St. Jude/UTHSC CRS | Memphis | Tennessee | 38105 | — |
| Vanderbilt Univ. Med. Ctr., Div. of Ped. Infectious Diseases | Nashville | Tennessee | 38105 | — |
| Texas Children's Hosp. CRS | Houston | Texas | 77030 | — |
| Univ. of Washington NICHD CRS | Seattle | Washington | 98105-0371 | — |
| UW Medicine - Harborview Med. Ctr., Northwest Family Ctr. | Seattle | Washington | 98105-0371 | — |
| UW School of Medicine - CHRMC | Seattle | Washington | 98105-0371 | — |
| Seattle Children's Hospital CRS | Seattle | Washington | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00017719, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 31, 2021 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00017719 live on ClinicalTrials.gov.