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COMPLETED 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)

NCT00000751 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 1,600 participants
Est. Completion 2007-08
Phase Phase 3

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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,600 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 237 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00000751 reports 20 study locations spanning 9 distinct geographic areas — top geographies include California, District of Columbia, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

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 237 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial