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Prospective Cohort Study of HIV and Zika in Infants and Pregnancy (HIV ZIP)

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ClinicalTrials.gov Identifier: NCT03263195
Recruitment Status : Recruiting
First Posted : August 28, 2017
Last Update Posted : August 8, 2018
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Westat

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.

Condition or disease
HIV Zika Virus Pregnant Women

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.


Study Type : Observational
Estimated Enrollment : 3800 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Cohort Study of HIV and Zika in Infants and Pregnancy
Actual Study Start Date : August 23, 2017
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Zika Virus

Group/Cohort
HIV-infected women
Pregnant women infected with HIV only and their infants.
ZIKV-infected women
Pregnant women infected with ZIKV only and their infants.
HIV- and ZIKV-infected women
Pregnant women infected with HIV and ZIKV and their infants.
Not HIV- or ZIKV- infected women
Pregnant women not infected with either HIV or ZIKV and their infants.



Primary Outcome Measures :
  1. Enrollment (150 HIV-infected and 50 HIV-uninfected pregnant women within one year, with a minimum of 20 of these women having HIV/ZIKV co-infection by their end of pregnancy). [ Time Frame: At the time of delivery of all those enrolled up to 1 year after the first enrollment ]
  2. Viral suppression (in HIV-infected women with ZIKV co-infection compared to those without ZIKV co-infection during pregnancy and at the time of delivery). [ Time Frame: Maternal Baseline, Second trimester, Third trimester and Delivery ]
  3. Incidence of ZIKV infection (among pregnant women with HIV infection compared to those without HIV infection). [ Time Frame: Maternal Baseline, Second trimester, Third trimester and Delivery ]
  4. Incidence of adverse pregnancy outcomes (in women co-infected with HIV and ZIKV, women infected with either HIV or ZIKV alone, and doubly uninfected women). [ Time Frame: Maternal Delivery ]
  5. Incidence of vertical transmission of HIV and ZIKV (in women co-infected with HIV and ZIKV and women infected with either HIV or ZIKV alone). [ Time Frame: Infant Birth, 3 months, 6 months, 12 months ]
  6. Incidence of congenital malformations (among offspring of women co-infected with HIV and ZIKV, women infected with either HIV or ZIKV alone, and doubly uninfected women). [ Time Frame: Infant Birth ]
  7. Incidence of other adverse outcomes among offspring of women co-infected with HIV and ZIKV, women infected with either HIV or ZIKV alone. [ Time Frame: Infant Birth, 3 months, 6 months, 12 months ]
  8. Growth, as measured by length, weight, and head circumference (among children with in utero exposure to HIV and ZIKV, in utero exposure to either HIV or ZIKV alone, and no in utero exposure to either virus). [ Time Frame: Infant Birth, 3 months, 6 months, 12 months ]
  9. Audiologic function as assessed by hearing levels, acoustic immitance, and otoacoustic emissions (among children with in utero exposure to HIV and ZIKV, in utero exposure to either HIV or ZIKV alone, and no in utero exposure to either virus). [ Time Frame: Within one month of infant birth, 3* months, 6* months, 12 months; (* follow-up for children with abnormal results at baseline) ]
  10. Ophthalmologic structure and function as assessed by ophthalmoscopy, fixation, and acuity card testing (among children with in utero exposure to HIV and ZIKV, in utero exposure to either HIV or ZIKV alone, and no in utero exposure to either virus). [ Time Frame: Within one month of infant birth, 12 months; *follow-up for children at 3 months and 6 months with abnormal results at baseline ]
  11. Neurodevelopment as assessed by the Bayley III and Ages and Stages Questionnaires- 3rd Edition (among children with in utero exposure to HIV and ZIKV, in utero exposure to either HIV or ZIKV alone, and no in utero exposure to either virus). [ Time Frame: Infant Birth, 3 months, 6 months, 12 months ]

Biospecimen Retention:   Samples With DNA
Maternal blood, maternal urine, cord blood, and placenta tissue. Infant blood and infant urine.


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
  1. Maternal Participants: a)Pregnant women, ages 15 years and older, who reside in a geographic area accessible to one of the selected clinical research sites in Brazil, Puerto Rico, and the continental United States, meet the criteria for ZIKV infection risk, are less than 18 weeks GA and are HIV-infected or uninfected (the latter in the continental U.S. only).

    b)HIV-infected and uninfected women (the latter in the continental U.S. only) at any gestational age who present with acute ZIKV-like symptoms and have confirmed ZIKV infection by a positive ZIKV RNA detection test at the Screening visit.

  2. Infant Participants: a)All infants born to women while enrolled in this study if the parent(s)/legal guardian(s) consents for the infant to participate. Infants may fall into one of the following groups: a) HIV-infected only; b) ZIKV-infected only; c) HIV- and ZIKV-infected; or d) HIV- and ZIKV-uninfected
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03263195


Contacts
Contact: Dina Monte, RN, BSN, CCRC 914-591-6170 dinamonte@westat.com
Contact: Lauren Laimon, MS 240-453-2987 laurenlaimon@westat.com

Locations
United States, Florida
University of Miami Pediatric/Prenatal HIV/AIDS Recruiting
Miami, Florida, United States, 33146
Contact: Grace Alvarez    305-243-4447    galvarez2@miami.edu   
United States, New York
Bronx-Lebanon Hospital Center NICHD CRS Recruiting
Bronx, New York, United States, 10457
Contact: Martha Cavallo, A.N.P., C.R.N.P.    718-960-1016    mcavallo@bronxleb.org   
United States, Texas
Baylor College of Medicine; Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Mary Paul, MD       mepaul@texaschildrens.org   
Contact: Mariam Pontifes    832-822-1268    mepontif@texaschildrens.org   
Brazil
SOM Federal University Minas Gerais Brazil NICHD CRS Recruiting
Belo Horizonte, Minas Gerais, Brazil, 30.130-100
Contact: Flavia G. Ferreira, M.D., D.Sc.    55-31-34099111    ffaleiroferreira@gmail.com   
Hospital Federal dos Servidores do Estado NICHD CRS Recruiting
Rio de Janeiro, Brazil, 20221-903
Contact: Leon C. Sidi, M.D.    55-21-22330018    leon@diphse.com.br   
Instituto de Puericultura e Pediatria Martagao Gesteira - UFRJ NICHD CRS Recruiting
Rio de Janeiro, Brazil, 21941-612
Contact: Maria da Conceicao C. Sapia, M.D.    55-21-99971-2285    macher.rlk@terra.com.br   
Hosp. Geral De Nova Igaucu Brazil NICHD CRS Recruiting
Rio de Janeiro, Brazil, 26030
Contact: Gisely G. Falco    55-21-99634-7239    gisely.falco@gmail.com   
University of Sao Paulo at Riberaio Preto Brazil Recruiting
São Paulo, Brazil, 14049-900
Contact: Adriana A Barbaro    55-1632345516    a.tiraboschi@uol.com.br   
Puerto Rico
University of Puerto Rico Pediatrics HIV/AIDS Research Program Recruiting
San Juan, Puerto Rico, 00936-5067
Contact: Ibet Heyer    787-7582525 ext 1576    ibet.heyer@upr.edu   
San Juan City Hosp. PR NICHD CRS Recruiting
San Juan, Puerto Rico, 00936
Contact: Lizbeth Fabregas-Troche, B.S., M.S.    787-764-3083    lfabregas@sanjuanciudadpatria.com   
Sponsors and Collaborators
Westat
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Study Chair: George R. Seage III, DSc, MPH Harvard T.H. Chan School of Public Health Department of Epidemiology
Study Chair: Marisa M. Mussi-Pinhata, MD University of Sao Paolo, Riberao Preto Medical School, Department of Pediatrics

Additional Information:
Responsible Party: Westat
ClinicalTrials.gov Identifier: NCT03263195     History of Changes
Other Study ID Numbers: HIV-ZIP
First Posted: August 28, 2017    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

De-identified participant data will be entered into the National Institute of Child Health and Human Development (NICHD) Data and Specimen Hub (N-DASH) system.

Data from the ZIP study, conducted in Zika-endemic areas, may be merged with HIV ZIP. In most cases, ZIP will have the exact same infant assessments as HIV ZIP.

Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: No later than one year after the date of acceptance for publication of the main findings from the final dataset.
Access Criteria: A Memorandum of Understanding (MOU) about the extent and nature of the sharing as well as a data use agreement will be executed for all collaborations. The MOU will include an understanding of the control of the use of the data, publication rights and authorship rights, as well as address the human participant's confidentiality issues

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Westat:
HIV
Zika Virus
Pregnancy
MTCT

Additional relevant MeSH terms:
Zika Virus Infection
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections