Prospective Cohort Study of HIV and Zika in Infants and Pregnancy

NCT ID: NCT03263195

Last Updated: 2022-01-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 395 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-08-23
• Study Completion Date: 2020-09-30

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 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.

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 with and without 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 U.S., P.R. and Brazil.

Phase I will enroll pregnant women/infant pairs who are: (1) infected with HIV only; (2) infected with ZIKV only; (3) infected with HIV and ZIKV; and (4) not infected with HIV or ZIKV. Phase I will assess the feasibility of enrolling a total of 200 pregnant women/infant pairs within a year, with a target of 150 HIV-infected women, 50 HIV-uninfected women from the continental U.S. sites only, and a minimum of 20 who are co-infected with HIV and ZIKV by the end of pregnancy.

Should the feasibility of Phase I prove successful, Phase II will commence by enrolling up to 1,800 additional pregnant women/infant pairs to the 4 groups described above. The comparison group of HIV-uninfected pregnant women/infant pairs from P.R and Brazil (ZIKV-infected and uninfected) will be obtained from data collected in the concurrent International Prospective Observational Cohort Study of Zika in Infants and Pregnancy (ZIP study).

All HIV-infected and uninfected study participants will be tested for ZIKV. Enrolled women will be followed throughout their pregnancy and up to six weeks postpartum. Infants born to enrolled women will be followed for a full year after birth. Thereafter, the infants born to women at continental U.S. and P.R. sites also implementing the Surveillance Monitoring for Antiretroviral Therapy (ART) Toxicities (SMARTT) study may be followed up yearly until adulthood through SMARTT depending on the availability of funds.

Conditions

HIV; Zika Virus; Pregnant Women

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Women with HIV only

Pregnant women with HIV infection only

No interventions assigned to this group

Women with ZIKV only

Pregnant women with ZIKV infection only

No interventions assigned to this group

Women with HIV and ZIKV

Pregnant women with HIV and ZIKV infection

No interventions assigned to this group

Women without HIV or ZIKV

Pregnant women without HIV or ZIKV infection

No interventions assigned to this group

Infants of women with HIV only

Infants of women with HIV infection during pregnancy

No interventions assigned to this group

Infants of women with ZIKV only

Infants of women with ZIKV infection during pregnancy

No interventions assigned to this group

Infants of women with HIV and ZIKV

Infants of women with HIV and ZIKV infection during pregnancy

No interventions assigned to this group

Infants of women without HIV or ZIKV

Infants of women without HIV or ZIKV infection during pregnancy

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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 Criteria

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.

• Minimum Eligible Age: 15 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

Westat

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marisa M. Mussi-Pinhata, MD

Role: STUDY_CHAIR

University of Sao Paolo, Riberao Preto Medical School, Department of Pediatrics

Locations

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

Countries

United States; Brazil; Puerto Rico

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form: Maternal Informed Consent

View Document

Document Type: Informed Consent Form: Infant Informed Consent

View Document

Other Identifiers

HHSN275201800001I

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HIV-ZIP

Identifier Type: -

Identifier Source: org_study_id