The Safety and Effectiveness of Zidovudine in HIV-Infected Pregnant Women and Their Infants
Public ClinicalTrials.gov record NCT00000960. 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
A Phase III Randomized Placebo-Controlled Trial to Evaluate the Efficacy, Safety and Tolerance of Oral Zidovudine (AZT) in Pregnant HIV Infected Women and Their Infants
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
To determine whether the rate of HIV transmission from mother to infant can be reduced by continuous oral zidovudine (AZT) treatment to HIV infected pregnant women, intravenous AZT during childbirth, and oral AZT treatment of the newborn infant from birth to six weeks of age. The study is also designed to evaluate the safety of AZT for both the pregnant woman and the newborn infant. No method exists to prevent transmission of HIV from an infected mother to her newborn infant. Giving an antiviral agent (such as AZT) to the mother and to the newborn could in theory decrease the risk of infection to the newborn by reducing the exposure of the fetus to maternal virus, or by preventive treatment of the fetus before exposure.
Study identification
- NCT ID
- NCT00000960
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,496 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 1 Day to 60 Years
- Sex
- All
- 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
- Jun 1994 (Actual)
- Last update posted
- Oct 29, 2021
Ends 1994
United States locations
- U.S. sites
- 58
- U.S. states
- 21
- U.S. cities
- 35
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Univ of Alabama at Birmingham Schl of Med / Pediatrics | Birmingham | Alabama | 35294 | — |
| Univ of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| 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 | — |
| Children's Hosp of Denver | Denver | Colorado | 802181088 | — |
| Univ of Connecticut / Farmington | Farmington | Connecticut | 06032 | — |
| Univ of Connecticut Health Ctr | Farmington | Connecticut | 06032 | — |
| Howard Univ Hosp | Washington D.C. | District of Columbia | 20060 | — |
| Univ of Miami (Pediatric) | Miami | Florida | 33161 | — |
| Northwestern Univ Med School | Chicago | Illinois | 60611 | — |
| Cook County Hosp | Chicago | Illinois | 60612 | — |
| Univ of Illinois College of Medicine / Pediatrics | Chicago | Illinois | 60612 | — |
| Chicago Children's Memorial Hosp | Chicago | Illinois | 606143394 | — |
| Univ of Chicago Children's Hosp | Chicago | Illinois | 606371470 | — |
| Tulane Univ / Charity Hosp of New Orleans | New Orleans | Louisiana | 701122699 | — |
| Univ of Maryland at Baltimore / Univ Med Ctr | Baltimore | Maryland | 21201 | — |
| Johns Hopkins Hosp - Pediatric | Baltimore | Maryland | 212874933 | — |
| Johns Hopkins Hosp | Baltimore | Maryland | 21287 | — |
| Children's Hosp of Boston | Boston | Massachusetts | 021155724 | — |
| Boston City Hosp / Pediatrics | Boston | Massachusetts | 02118 | — |
| Beth Israel Deaconess Med Ctr | Boston | Massachusetts | 02215 | — |
| Baystate Med Ctr of Springfield | Springfield | Massachusetts | 01199 | — |
| Univ of Massachusetts Med Ctr | Worcester | Massachusetts | 01655 | — |
| Children's Hosp of Michigan | Detroit | Michigan | 48201 | — |
| UMDNJ - New Jersy Med School | Newark | New Jersey | 071032714 | — |
| Univ of Medicine & Dentistry of New Jersey / Univ Hosp | Newark | New Jersey | 071032714 | — |
| Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl | Newark | New Jersey | 071072198 | — |
| Children's Hosp at Albany Med Ctr | Albany | New York | 12208 | — |
| SUNY - Brooklyn | Brooklyn | New York | 11203 | — |
| SUNY / Health Sciences Ctr at Brooklyn / Pediatrics | Brooklyn | New York | 11203 | — |
| Beth Israel Med Ctr / Pediatrics | New York | New York | 10003 | — |
| Bellevue Hosp / New York Univ Med Ctr | New York | New York | 10016 | — |
| Cornell Univ Med College | New York | New York | 10021 | — |
| Mount Sinai Med Ctr / Pediatrics | New York | New York | 10029 | — |
| Columbia Presbyterian Med Ctr | New York | New York | 10032 | — |
| Univ of Rochester Medical Center | Rochester | New York | 14642 | — |
| 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 | — |
| Albert Einstein College of Medicine | The Bronx | New York | 10461 | — |
| Westchester Hosp | Valhalla | New York | 10595 | — |
| Univ of North Carolina | Chapel Hill | North Carolina | 275997215 | — |
| Carolinas Med Ctr | Charlotte | North Carolina | 28203 | — |
| Duke Univ Med Ctr | Durham | North Carolina | 277103499 | — |
| Univ of Cincinnati | Cincinnati | Ohio | 452670405 | — |
| Children's Hosp of Philadelphia | Philadelphia | Pennsylvania | 191044318 | — |
| Hosp of the Univ of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Thomas Jefferson Univ Hosp | Philadelphia | Pennsylvania | 191075098 | — |
| Rhode Island Hosp / Brown Univ | Providence | Rhode Island | 02903 | — |
| Med Univ of South Carolina | Charleston | South Carolina | 294253312 | — |
| Saint Jude Children's Research Hosp of Memphis | Memphis | Tennessee | 381052794 | — |
| Children's Med Ctr of Dallas | Dallas | Texas | 75235 | — |
| Lyndon Baines Johnson Gen Hosp | Houston | Texas | 77030 | — |
| Texas Children's Hosp / Baylor Univ | Houston | Texas | 77030 | — |
| Children's Hosp of Seattle | Seattle | Washington | 98105 | — |
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 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00000960, 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 29, 2021 · Synced Oct 25, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00000960 live on ClinicalTrials.gov.