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NCT00000960 · ClinicalTrials.gov registry record · Phase 3
The Safety and Effectiveness of Zidovudine in HIV-Infected Pregnant Women and Their Infants
A Phase 3 study of HIV Infections and Pregnancy, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 3
- Development phase
- 1,496
- Enrollment target
- 20
- Study locations
NCT00000960 is a Phase 3 study of HIV Infections and Pregnancy that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 1,496 participants, above the 443-participant average among 542 other HIV Infections trials with a reported enrollment target (238% higher). The trial reports 20 study locations across 9 states.
The verdict
NCT00000960, a Phase 3 study of HIV Infections and Pregnancy, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,496 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Zidovudine
Study Locations (20)
California
- UCSD Med Ctr / Pediatrics / Clinical Sciences - La Jolla
- Los Angeles County - USC Med Ctr - Los Angeles
- UCLA Med Ctr / Pediatric - Los Angeles
- Harbor - UCLA Med Ctr / UCLA School of Medicine - Los Angeles
- San Francisco Gen Hosp - San Francisco
Illinois
- Northwestern Univ Med School - Chicago
- Cook County Hosp - Chicago
- Univ of Illinois College of Medicine / Pediatrics - Chicago
- Chicago Children's Memorial Hosp - Chicago
- Univ of Chicago Children's Hosp - Chicago
Alabama
- Univ of Alabama at Birmingham Schl of Med / Pediatrics - Birmingham
- Univ of Alabama at Birmingham - Birmingham
Connecticut
- Univ of Connecticut / Farmington - Farmington
- Univ of Connecticut Health Ctr - Farmington
Maryland
- Univ of Maryland at Baltimore / Univ Med Ctr - Baltimore
- Johns Hopkins Hosp - Pediatric - Baltimore
Colorado
- Children's Hosp of Denver - Denver
District of Columbia
- Howard Univ Hosp - Washington D.C.
Florida
- Univ of Miami (Pediatric) - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,496 participants |
| Est. Completion | 1994-06 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000960
The ClinicalTrials.gov registry entry for NCT00000960 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,496 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 443-participant average among 542 other HIV Infections trials with a reported enrollment target (238% higher). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 1 intervention - of which Zidovudine is the first listed.
NCT00000960 reports 20 study locations spanning 9 distinct geographic areas - top geographies include California, Illinois, Alabama.
Frequently Asked Questions
What is clinical trial NCT00000960 about?
NCT00000960 is a clinical study titled "The Safety and Effectiveness of Zidovudine in HIV-Infected Pregnant Women and Their Infants". 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 desig...
What is the current status of trial NCT00000960?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,496 participants. Estimated completion is 1994-06.
What conditions does trial NCT00000960 study?
This clinical trial studies the following conditions: HIV Infections, Pregnancy.
What interventions are being tested in trial NCT00000960?
The interventions under investigation include: Zidovudine (DRUG).
Who is sponsoring clinical trial NCT00000960?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00000960 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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