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NCT00000751 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study of HIV Infections and Pregnancy, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Completed
- Registry status
- Phase 3
- Development phase
- 1,600
- Enrollment target
- 20
- Study locations
NCT00000751 is a Phase 3 study of HIV Infections and Pregnancy that has completed, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 1,600 participants, above the 443-participant average among 542 other HIV Infections trials with a reported enrollment target (261% higher). The trial reports 20 study locations across 9 states.
The verdict
NCT00000751, a Phase 3 study of HIV Infections and Pregnancy, has completed, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,600 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Zidovudine
- DRUG Anti-HIV Immune Serum Globulin (Human)
- DRUG Globulin, Immune
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
- UCSF / Moffitt Hosp - Pediatric - San Francisco
District of Columbia
- Children's Hosp of Washington DC - Washington D.C.
- Washington Hosp Ctr - Washington D.C.
- Howard Univ Hosp - Washington D.C.
Colorado
- Denver Gen Hosp - Denver
- Children's Hosp of Denver - Denver
Florida
- Univ of Florida Health Science Ctr / Pediatrics - Jacksonville
- Univ of Miami (Pediatric) - Miami
Louisiana
- Tulane Univ / Charity Hosp of New Orleans - New Orleans
- Univ Hosp - New Orleans
Maryland
- Univ of Maryland at Baltimore / Univ Med Ctr - Baltimore
- Johns Hopkins Hosp - Pediatric - Baltimore
Connecticut
- Univ of Connecticut / Farmington - Farmington
Illinois
- Univ of Illinois College of Medicine / Pediatrics - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,600 participants |
| Est. Completion | 2007-08 |
| Phase | Phase 3 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000751
The ClinicalTrials.gov registry entry for NCT00000751 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,600 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 (261% higher). The listed sponsor is Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 3 interventions - of which Zidovudine is the first listed.
NCT00000751 reports 20 study locations spanning 9 distinct geographic areas - top geographies include California, District of Columbia, Colorado.
Frequently Asked Questions
What is clinical trial NCT00000751 about?
NCT00000751 is a clinical study titled "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)". 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 r...
What is the current status of trial NCT00000751?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,600 participants. Estimated completion is 2007-08.
What conditions does trial NCT00000751 study?
This clinical trial studies the following conditions: HIV Infections, Pregnancy.
What interventions are being tested in trial NCT00000751?
The interventions under investigation include: Zidovudine (DRUG), Anti-HIV Immune Serum Globulin (Human) (DRUG), Globulin, Immune (DRUG).
Who is sponsoring clinical trial NCT00000751?
This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00000751 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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