Status:
COMPLETED
Prospective Cohort Study of HIV and Zika in Infants and Pregnancy
Lead Sponsor:
Westat
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV
Zika Virus
Eligibility:
FEMALE
15+ years
Brief 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 adv...
Detailed Description
This is a two-phase prospective international cohort study of pregnant women and their infants from those pregnancies whose goals are to compare the incidence of ZIKV infection among pregnant women wi...
Eligibility Criteria
Inclusion
- Maternal
- Provides written informed consent (IC) (or assent and parent(s)/legal guardian(s) permission, where required per state or country regulations).
- Age 15 years or older at enrollment.
- Confirmation of pregnancy by βhCG measurement in blood or urine or fetal ultrasound (US) heart tones present.
- Based on pregnancy calculator or fetal US: Confirmation of being at \<18 weeks gestational age (GA) of pregnancy or at any GA if presents with acute ZIKV-like symptoms (i.e., fever, rash, arthralgia, myalgia, pruritus, headache, eye pain, and conjunctivitis) and has laboratory-confirmed ZIKV infection by ZIKV RNA detection.
- Plans on remaining in the area of the current study site or if moving, within an area of any other study site, for the duration of her and her child's participation.
- Willingness of parent(s)/legal guardian(s) to provide written consent to enroll the infant from the current pregnancy once delivered.
- Has met one of the following three ZIKV-exposure risk categories:
- Has resided in for at least three months or traveled within the last three months to a country or United States (U.S.) territory with active, cautionary, or previously active or cautionary ZIKV transmission based on the list found at http://www.cdc.gov/zika/geo/active-countries.html; or
- Sexual partner has resided in or traveled within the last six months to a country or U.S. territory with active, cautionary, or previously active or cautionary ZIKV transmissions, or was diagnosed with ZIKV within the previous six months; or
- Household member has been diagnosed with ZIKV infection or has traveled since the woman's last menstrual period (LMP) to a country or U.S. territory with active, cautionary, or previously active or cautionary ZIKV transmission.
- For HIV-infected women only: Laboratory evidence or clinical criteria for a confirmed case of HIV infection per Centers for Disease Control and Prevention (CDC) Surveillance Case Definition for HIV, 2014 (Section 1.1.1 or Section 1.1.2) http://www.cdc.gov/mmwr/preview/mmwrhtml/rr6303a1.htm.
- Infant
- Born to an enrolled mother.
- Parent(s)/legal guardian(s) provided written IC for his or her child to participate.
Exclusion
- Maternal:
- Incarcerated or placed in detention.
- Enrolled in other clinical research (including other ZIKV research) requiring blood collection, which in combination with HIV ZIP evaluations would exceed a total blood draw volume of 50 mL in an eight-week period and/or blood collection would be required more frequently than two times per week.
- Infant:
- •Enrolled in other clinical research (including other ZIKV research) requiring blood collection, which in combination with HIV ZIP evaluations, would exceed three mL per kg in an eight week period and/or blood collection would be required more frequently than two times per week.
Key Trial Info
Start Date :
August 23 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 30 2020
Estimated Enrollment :
395 Patients enrolled
Trial Details
Trial ID
NCT03263195
Start Date
August 23 2017
End Date
September 30 2020
Last Update
January 14 2022
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Miami Pediatric/Prenatal HIV/AIDS
Miami, Florida, United States, 33146
2
Bronx-Lebanon Hospital Center NICHD CRS
The Bronx, New York, United States, 10457
3
Baylor College of Medicine; Texas Children's Hospital
Houston, Texas, United States, 77030
4
Baylor College of Medicine
Houston, Texas, United States, 77030