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NCT03263195 · ClinicalTrials.gov registry record
Prospective Cohort Study of HIV and Zika in Infants and Pregnancy
A clinical trial of HIV and Pregnant Women, sponsored by Westat.
- Completed
- Registry status
- 395
- Enrollment target
- 11
- Study locations
NCT03263195: Completed study of HIV and Pregnant Women, sponsored by Westat.
NCT03263195 is a study of HIV and Pregnant Women that has completed, run by Westat. The registered enrollment target is 395 participants, below the 439-participant average among 303 other HIV trials with a reported enrollment target (10% lower). The trial reports 11 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03263195, a study of HIV and Pregnant Women, has completed, sponsored by Westat.
- COMPLETED
- Registry status
- 395 participants
- Enrollment target
- 11
- Study locations
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.
Primary Outcome
This outcome measured feasibility of enrolling 150 pregnant women living with HIV and 50 pregnant women without HIV, with a minimum of 20 of these women having HIV/ZIKV co-infection by their end of pregnancy
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 395 participants |
| Start Date | 2017-08-23 |
| Est. Completion | 2020-09-30 |
What the finished NCT03263195 record still lists
NCT03263195 is an observational study that tracks outcomes without assigning an intervention. The registered 395 participants enrollment target is mid-sized for trials with a published cap, below the 439-participant average among 303 other HIV trials with a reported enrollment target (10% lower).
The record links to 3 conditions, with HIV appearing as the primary indexed condition, and to 0 interventions.
NCT03263195 lists 11 locations in 5 states (Other, Texas, Florida).
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.
Who is sponsoring clinical trial NCT03263195?
This trial is sponsored by Westat, which has 13 total clinical trials registered on ClinicalTrials.gov.
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.
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395 48th of 303 higher than 256 of 303 other HIV trials
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