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Prospective Cohort Study of HIV and Zika in Infants and Pregnancy

NCT03263195 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to compare the incidence of Zika virus (ZIKV) infection among pregnant women with and without Human Immunodeficiency Virus (HIV) infection and to determine the risk of adverse maternal and child outcomes associated with ZIKV/HIV co-infection across clinical sites in the continental United States (U.S.), Puerto Rico (P.R.) and Brazil.

Study Locations (11)

Other

  • Hospital Federal dos Servidores do Estado NICHD CRS — Rio de Janeiro
  • Instituto de Puericultura e Pediatria Martagao Gesteira - UFRJ NICHD CRS — Rio de Janeiro
  • Hosp. Geral De Nova Igaucu Brazil NICHD CRS — Rio de Janeiro
  • University of Sao Paulo at Riberaio Preto Brazil — São Paulo
  • University of Puerto Rico Pediatrics HIV/AIDS Research Program — San Juan
  • San Juan City Hosp. PR NICHD CRS — San Juan

Texas

  • Baylor College of Medicine; Texas Children's Hospital — Houston
  • Baylor College of Medicine — Houston

Florida

  • University of Miami Pediatric/Prenatal HIV/AIDS — Miami

New York

  • Bronx-Lebanon Hospital Center NICHD CRS — The Bronx

Minas Gerais

  • SOM Federal University Minas Gerais Brazil NICHD CRS — Belo Horizonte

Trial Details

FieldValue
Enrollment Target 395 participants
Start Date 2017-08-23
Est. Completion 2020-09-30

Sponsor

Westat

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03263195

The ClinicalTrials.gov registry entry for NCT03263195 describes a study currently listed as completed. It is categorized as an unspecified phase, 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 395 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Westat, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with HIV appearing as the primary indexed condition, and to 0 interventions. 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: NCT03263195 reports 11 study locations spanning 5 distinct geographic areas — top geographies include Other, Texas, Florida. 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 NCT03263195 about?

NCT03263195 is a clinical study titled "Prospective Cohort Study of HIV and Zika in Infants and Pregnancy". The purpose of this study is to compare the incidence of Zika virus (ZIKV) infection among pregnant women with and without Human Immunodeficiency Virus (HIV) infection and to determine the risk of adverse maternal and child outcomes associated with ZIKV/HIV co-infection across clinical sites in the ...

What is the current status of trial NCT03263195?

This trial is currently completed. The enrollment target is 395 participants. The study started on 2017-08-23. Estimated completion is 2020-09-30.

What conditions does trial NCT03263195 study?

This clinical trial studies the following conditions: HIV, Pregnant Women, Zika Virus. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

Who is sponsoring clinical trial NCT03263195?

This trial is sponsored by Westat, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03263195 being conducted?

This trial has 11 study locations across Florida, New York, Texas, Minas Gerais. 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