A Phase III Randomized, Double-Blind, Controlled Study of the Use of Anti-HIV Immune Serum Globulin (HIVIG) for the Prevention of Maternal-Fetal HIV Transmission in Pregnant Women and Newborns Receiving Zidovudine (AZT)
Public ClinicalTrials.gov record NCT00000751. 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.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
To evaluate the effect of anti-HIV immune serum globulin (HIVIG) versus immune globulin (IVIG) administered during pregnancy and to the newborn, in combination with zidovudine (AZT) administered intrapartum and to the newborn, on incidence of HIV infection in infants born to HIV-infected women who received AZT during pregnancy for medical indications. Vertical transmission of HIV from mother to child may occur before, during, or after parturition (via breast-feeding). It is believed that therapy administered both during pregnancy and intrapartum may help prevent vertical transmission. Additionally, adjunctive short-term antiretroviral therapy for the newborn, following the intensive viral exposure presumed to occur at birth, may be necessary.
Study identification
- NCT ID
- NCT00000751
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- NIH
- Enrollment
- 1,600 participants
Conditions and interventions
Conditions
Interventions
- Anti-HIV Immune Serum Globulin (Human) Drug
- Globulin, Immune Drug
- Zidovudine Drug
Drug
Eligibility (public fields only)
- Age range
- 13 Years to 60 Years
- 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
- Not listed
- Primary completion
- Not listed
- Completion
- Aug 2007 (Actual)
- Last update posted
- Sep 30, 2008
Ends 2007
United States locations
- U.S. sites
- 48
- U.S. states
- 19
- U.S. cities
- 29
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCSD Med Ctr / Pediatrics / Clinical Sciences | La Jolla | California | 920930672 | — |
| Los Angeles County - USC Med Ctr | Los Angeles | California | 90033 | — |
| UCLA Med Ctr / Pediatric | Los Angeles | California | 900951752 | — |
| Harbor - UCLA Med Ctr / UCLA School of Medicine | Los Angeles | California | 905022004 | — |
| San Francisco Gen Hosp | San Francisco | California | 94110 | — |
| UCSF / Moffitt Hosp - Pediatric | San Francisco | California | 941430105 | — |
| Denver Gen Hosp | Denver | Colorado | 802044507 | — |
| Children's Hosp of Denver | Denver | Colorado | 802181088 | — |
| Univ of Connecticut / Farmington | Farmington | Connecticut | 06032 | — |
| Children's Hosp of Washington DC | Washington D.C. | District of Columbia | 200102916 | — |
| Washington Hosp Ctr | Washington D.C. | District of Columbia | 200102931 | — |
| Howard Univ Hosp | Washington D.C. | District of Columbia | 20060 | — |
| Univ of Florida Health Science Ctr / Pediatrics | Jacksonville | Florida | 32209 | — |
| Univ of Miami (Pediatric) | Miami | Florida | 33161 | — |
| Univ of Illinois College of Medicine / Pediatrics | Chicago | Illinois | 60612 | — |
| Tulane Univ / Charity Hosp of New Orleans | New Orleans | Louisiana | 701122699 | — |
| Univ Hosp | New Orleans | Louisiana | 70112 | — |
| Univ of Maryland at Baltimore / Univ Med Ctr | Baltimore | Maryland | 21201 | — |
| Johns Hopkins Hosp - Pediatric | Baltimore | Maryland | 212874933 | — |
| Children's Hosp of Boston | Boston | Massachusetts | 021155724 | — |
| Brigham and Women's Hosp | Boston | Massachusetts | 02115 | — |
| Boston City Hosp / Pediatrics | Boston | Massachusetts | 02118 | — |
| Baystate Med Ctr of Springfield | Springfield | Massachusetts | 01199 | — |
| Univ of Massachusetts Med School | Worcester | Massachusetts | 016550001 | — |
| Children's Hosp of Michigan | Detroit | Michigan | 48201 | — |
| Univ of Medicine & Dentistry of New Jersey / Univ Hosp | Newark | New Jersey | 071032714 | — |
| Children's Hosp at Albany Med Ctr | Albany | New York | 12208 | — |
| Bellevue Hosp / New York Univ Med Ctr | New York | New York | 10016 | — |
| Mount Sinai Med Ctr / Pediatrics | New York | New York | 10029 | — |
| Columbia Presbyterian Med Ctr | New York | New York | 10032 | — |
| State Univ of New York at Stony Brook | Stony Brook | New York | 117948111 | — |
| SUNY Health Sciences Ctr at Syracuse / Pediatrics | Syracuse | New York | 13210 | — |
| Bronx Lebanon Hosp Ctr | The Bronx | New York | 10457 | — |
| Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr | Durham | North Carolina | 27710 | — |
| Case Western Reserve Univ - Pediatric | Cleveland | Ohio | 44106 | — |
| Children's Hosp of Philadelphia | Philadelphia | Pennsylvania | 191044318 | — |
| Hosp of the Univ of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Thomas Jefferson Univ Hosp | Philadelphia | Pennsylvania | 191075098 | — |
| Saint Christopher's Hosp for Children | Philadelphia | Pennsylvania | 191341095 | — |
| Temple Univ School of Medicine | Philadelphia | Pennsylvania | 191341095 | — |
| Med Univ of South Carolina | Charleston | South Carolina | 294253312 | — |
| Regional Med Ctr at Memphis | Memphis | Tennessee | 38103 | — |
| Methodist Hosp Central | Memphis | Tennessee | 381052794 | — |
| Saint Jude Children's Research Hosp of Memphis | Memphis | Tennessee | 381052794 | — |
| Children's Med Ctr of Dallas | Dallas | Texas | 75235 | — |
| Hermann Hosp / Univ Texas Health Science Ctr | Houston | Texas | 77030 | — |
| Texas Children's Hosp / Baylor Univ | Houston | Texas | 77030 | — |
| Children's Hospital & Medical Center / Seattle ACTU | Seattle | Washington | 981050371 | — |
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 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00000751, 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 Sep 30, 2008 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00000751 live on ClinicalTrials.gov.