Prospective Cohort Study of HIV and Zika in Infants and Pregnancy

Completed

Conditions studied: HIV, Zika Virus, Pregnant Women

In brief

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.

Key facts

Study ID

NCT03263195

Run by

Westat

People needed

395

Starts

2017-08-23

Expected to finish

2020-09-30

Last updated by the study team

2022-01-14

Who can join

Age: 15 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Miami Pediatric/Prenatal HIV/AIDS — Miami, Florida, United States
• Bronx-Lebanon Hospital Center NICHD CRS — The Bronx, New York, United States
• Baylor College of Medicine; Texas Children's Hospital — Houston, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States
• SOM Federal University Minas Gerais Brazil NICHD CRS — Belo Horizonte, Minas Gerais, Brazil
• Hospital Federal dos Servidores do Estado NICHD CRS — Rio de Janeiro, Brazil
• Instituto de Puericultura e Pediatria Martagao Gesteira - UFRJ NICHD CRS — Rio de Janeiro, Brazil
• Hosp. Geral De Nova Igaucu Brazil NICHD CRS — Rio de Janeiro, Brazil
• University of Sao Paulo at Riberaio Preto Brazil — São Paulo, Brazil
• University of Puerto Rico Pediatrics HIV/AIDS Research Program — San Juan, Puerto Rico
• San Juan City Hosp. PR NICHD CRS — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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