HIVHIV ZIPNCT03263195
Prospective Cohort Study of HIV and Zika in Infants and Pregnancy
An observational study of HIV and Zika Virus, run by Westat at 11 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV, Zika Virus, Pregnant Women
- How many people
- 395 participants
- Where
- 11 sitesin 3 countries
- Study dates
- 23 Aug 2017to 30 Sep 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Maternal: HIV infected or uninfected (the latter in the continental U.S only) pregnant women, ages 15 years and older, residing in a geographic area accessible to a research site in Brazil, Puerto Rico or the continental U.S., meet the ZIKV infection risk criteria and are less than 18 weeks GA or any GA if presenting with acute ZIKV-like symptoms and have confirmed ZIKV infection by positive ZIKV RNA detection at the Screening visit. Infant: All infants born to women while enrolled in this study if the parent(s)/legal guardian(s) consents for the infant's participation. Infants may be in one of the following groups: a) HIV infected only; b) ZIKV infected only; c) HIV and ZIKV infected; or d) HIV and ZIKV uninfected
Who may be able to join
- 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.
Show all 15Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
11 sites in 3 countries.
11 sites in 3 countries
Brazil5 sites
SOM Federal University Minas Gerais Brazil NICHD CRS
Belo Horizonte, Minas Gerais, 30.130-100
Hospital Federal dos Servidores do Estado NICHD CRS
Rio de Janeiro, 20221-903
Instituto de Puericultura e Pediatria Martagao Gesteira - UFRJ NICHD CRS
Rio de Janeiro, 21941-612
Hosp. Geral De Nova Igaucu Brazil NICHD CRS
Rio de Janeiro, 26030
University of Sao Paulo at Riberaio Preto Brazil
São Paulo, 14049-900
United States4 sites
Baylor College of Medicine; Texas Children's Hospital
Houston, Texas, 77030
Baylor College of Medicine
Houston, Texas, 77030
University of Miami Pediatric/Prenatal HIV/AIDS
Miami, Florida, 33146
Bronx-Lebanon Hospital Center NICHD CRS
The Bronx, New York, 10457
Puerto Rico2 sites
University of Puerto Rico Pediatrics HIV/AIDS Research Program
San Juan, 00936-5067
San Juan City Hosp. PR NICHD CRS
San Juan, 00936
About this study
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.
Read the 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
- Keywords
- HIV, Zika Virus, Pregnancy, MTCT
- Medical subject headings
- Zika Virus Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Women with HIV only | Pregnant women with HIV infection only | |
| Women with ZIKV only | Pregnant women with ZIKV infection only | |
| Women with HIV and ZIKV | Pregnant women with HIV and ZIKV infection | |
| Women without HIV or ZIKV | Pregnant women without HIV or ZIKV infection | |
| Infants of women with HIV only | Infants of women with HIV infection during pregnancy | |
| Infants of women with ZIKV only | Infants of women with ZIKV infection during pregnancy | |
| Infants of women with HIV and ZIKV | Infants of women with HIV and ZIKV infection during pregnancy | |
| Infants of women without HIV or ZIKV | Infants of women without HIV or ZIKV infection during pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
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
Measured: At the time of delivery of all those enrolled up to 1 year after the first enrollment
Viral Suppression (in HIV-infected Women With ZIKV Co-infection Compared to Those Without ZIKV Co-infection During Pregnancy) at the Time of Delivery.
This outcome intended to measure HIV suppression at the time of delivery among women living with HIV with and without ZIKV infection during pregnancy. Note there were no women with ZIKV infection in pregnancy. Viral suppression was defined at different thresholds (<40 copies/mL, <400 copies/mL, <1000 copies/mL).
Measured: Maternal viral load at delivery
Incidence of ZIKV Infection (Among Pregnant Women With HIV Infection Compared to Those Without HIV Infection).
Cumulative incidence of ZIKV infection during pregnancy (among pregnant women with HIV infection compared to those without HIV infection).
Measured: Maternal baseline to delivery
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).
Adverse pregnancy outcomes included miscarriage, stillbirth and preterm delivery. Note there were no women with ZIKV infection in pregnancy.
Miscarriage was defined as fetal demise at <20 weeks of gestation. Stillbirth was defined as fetal demise at ≥20 weeks of gestation. Preterm delivery was defined as delivery at <37 weeks of gestation.
Measured: At time of delivery
Incidence of Vertical Transmission of HIV and/or ZIKV (in Women Co-infected With HIV and ZIKV and Women Infected With Either HIV or ZIKV Alone).
Cumulative incidence of confirmed HIV infection among enrolled infants. Note there were no women with ZIKV infection in pregnancy so therefore no risk of transmission of ZIKV to any infants.
Measured: Infant birth to 12 months
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).
Cumulative incidence of congenital malformations. Note there were no women with ZIKV infection in pregnancy.
Observed major congenital malformations included: anhydramnios, cerebral ventriculomegaly, clubfoot (unresolved), Down syndrome, hydrops, hypospadias, patient ductus arteriosus, polydactyly (left foot), Potter syndrome, short stature, syndactyly (left foot, 1st and 2nd toes).
Observed minor congenital malformations included: clubfoot (resolved), cryptorchidism (bilateral), dislocated hip, heart defect (patent foramen ovale), heart murmur (unresolved), hemangioma, hip dysplasia, hydrocele, inguinal hernia, head circumference -3 ≤ z-score <-2, persistent ductus arteriosus (resolved), plagiocephaly, restrictive ductus arteriosus, renal pyelectasis, sacral dimple, small perimembranous ventricular septal defect, stenosis of nasolacrimal duct, umbilical hernia.
Measured: Infant birth, 3 months
Incidence of Other Adverse Outcomes Among Offspring of Women Co-infected With HIV and ZIKV, Women Infected With Either HIV or ZIKV Alone.
Other adverse outcomes included microcephaly, neonatal dealth, central nervous system (CNS) malformation, hydrops, and ocular abnormalities. Note there were no women with ZIKV infection in pregnancy.
Microcephaly was defined as head circumference less than a z-score of -3 at birth or 3 month visit.
Neonatal death was defined as death within 28 days of life. Observed CNS malformations included: cerebral ventriculomegaly. Ocular abnormalities included both structural and functional ophthalmologic abnormalities.
Measured: Infant birth to 12 months
Weight Among Children With or Without in Utero Exposure to HIV and/or ZIKV
Weight as a measure of growth. Note there were no women with ZIKV infection in pregnancy.
Measured: Infant Birth, 3 months, 6 months, 12 months
Length and Head Circumference Among Children With and Without in Utero Exposure to HIV and/or ZIKV
Length and head circumference as measures of growth. Note there were no women with ZIKV infection in pregnancy.
Measured: Infant Birth, 3 months, 6 months, 12 months
Audiologic Function Among Children With or Without in Utero Exposure to HIV and/or ZIKV
Audiologic function as assessed by OAE test reported. Note there were no women with ZIKV infection in pregnancy.
Measured: Within one month of infant birth, 3 months, 6 months, 12 months
Ophthalmologic Structure and Function Among Children With or Without in Utero Exposure to HIV and/or ZIKV
Ocular abnormalities included both structural and functional ophthalmologic abnormalities. Note there were no women with ZIKV infection in pregnancy.
Measured: Within one month of infant birth, 12 months;
Neurodevelopment Among Children With or Without in Utero Exposure to HIV and/or ZIKV
Infant neurodevelopment was assessed by either the Bayley III or Ages and Stages Questionnaires- 3rd Edition. Combined results reported. Note there were no women with ZIKV infection in pregnancy.
Measured: Infant 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2017
- Study start23 Aug 2017
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 395 participants (actual)
Sponsor and investigators
- Lead sponsor
- Westat
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Sponsor
- Investigators
- Marisa M. Mussi-Pinhata, MD, Study chair, University of Sao Paolo, Riberao Preto Medical School, Department of Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03263195
- Sponsor's protocol ID
- HIV-ZIP
- Other IDs
- HHSN275201800001I
- Acronym
- HIV ZIP
- Status last verified
- Jan 2022
- First submitted
- 9 Aug 2017
- Last updated
- 14 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study of HIV and Zika in Infants and Pregnancy
- ClinicalTrials.gov ID
- NCT03263195
- Acronym / sponsor ID
- HIV ZIP / HIV-ZIP
- Conditions
- HIV, Zika Virus, Pregnant Women
- Keywords
- HIV, Zika Virus, Pregnancy, MTCT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 395 participants (actual)
- Lead sponsor
- WestatUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 23 Aug 2017 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 28 Aug 2017 (actual)
- Results
- Posted 14 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Women with HIV only | – | –Pregnant women with HIV infection only |
| Women with ZIKV only | – | –Pregnant women with ZIKV infection only |
| Women with HIV and ZIKV | – | –Pregnant women with HIV and ZIKV infection |
| Women without HIV or ZIKV | – | –Pregnant women without HIV or ZIKV infection |
| Infants of women with HIV only | – | –Infants of women with HIV infection during pregnancy |
| Infants of women with ZIKV only | – | –Infants of women with ZIKV infection during pregnancy |
| Infants of women with HIV and ZIKV | – | –Infants of women with HIV and ZIKV infection during pregnancy |
| Infants of women without HIV or ZIKV | – | –Infants of women without HIV or ZIKV infection during pregnancy |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Maternal: HIV infected or uninfected (the latter in the continental U.S only) pregnant women, ages 15 years and older, residing in a geographic area accessible to a research site in Brazil, Puerto Rico or the continental U.S., meet the ZIKV infection risk criteria and are less than 18 weeks GA or any GA if presenting with acute ZIKV-like symptoms and have confirmed ZIKV infection by positive ZIKV RNA detection at the Screening visit. Infant: All infants born to women while enrolled in this study if the parent(s)/legal guardian(s) consents for the infant's participation. Infants may be in one of the following groups: a) HIV infected only; b) ZIKV infected only; c) HIV and ZIKV infected; or d) HIV and ZIKV uninfected
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
- •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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
Viral Suppression (in HIV-infected Women With ZIKV Co-infection Compared to Those Without ZIKV Co-infection During Pregnancy) at the Time of Delivery.
Time frame: Maternal viral load at delivery
This outcome intended to measure HIV suppression at the time of delivery among women living with HIV with and without ZIKV infection during pregnancy. Note there were no women with ZIKV infection in pregnancy. Viral suppression was defined at different thresholds (<40 copies/mL, <400 copies/mL, <1000 copies/mL).
Incidence of ZIKV Infection (Among Pregnant Women With HIV Infection Compared to Those Without HIV Infection).
Time frame: Maternal baseline to delivery
Cumulative incidence of ZIKV infection during pregnancy (among pregnant women with HIV infection compared to those without HIV infection).
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: At time of delivery
Adverse pregnancy outcomes included miscarriage, stillbirth and preterm delivery. Note there were no women with ZIKV infection in pregnancy. Miscarriage was defined as fetal demise at <20 weeks of gestation. Stillbirth was defined as fetal demise at ≥20 weeks of gestation. Preterm delivery was defined as delivery at <37 weeks of gestation.
Incidence of Vertical Transmission of HIV and/or ZIKV (in Women Co-infected With HIV and ZIKV and Women Infected With Either HIV or ZIKV Alone).
Time frame: Infant birth to 12 months
Cumulative incidence of confirmed HIV infection among enrolled infants. Note there were no women with ZIKV infection in pregnancy so therefore no risk of transmission of ZIKV to any infants.
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, 3 months
Cumulative incidence of congenital malformations. Note there were no women with ZIKV infection in pregnancy. Observed major congenital malformations included: anhydramnios, cerebral ventriculomegaly, clubfoot (unresolved), Down syndrome, hydrops, hypospadias, patient ductus arteriosus, polydactyly (left foot), Potter syndrome, short stature, syndactyly (left foot, 1st and 2nd toes). Observed minor congenital malformations included: clubfoot (resolved), cryptorchidism (bilateral), dislocated hip, heart defect (patent foramen ovale), heart murmur (unresolved), hemangioma, hip dysplasia, hydrocele, inguinal hernia, head circumference -3 ≤ z-score <-2, persistent ductus arteriosus (resolved), plagiocephaly, restrictive ductus arteriosus, renal pyelectasis, sacral dimple, small perimembranous ventricular septal defect, stenosis of nasolacrimal duct, umbilical hernia.
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 to 12 months
Other adverse outcomes included microcephaly, neonatal dealth, central nervous system (CNS) malformation, hydrops, and ocular abnormalities. Note there were no women with ZIKV infection in pregnancy. Microcephaly was defined as head circumference less than a z-score of -3 at birth or 3 month visit. Neonatal death was defined as death within 28 days of life. Observed CNS malformations included: cerebral ventriculomegaly. Ocular abnormalities included both structural and functional ophthalmologic abnormalities.
Weight Among Children With or Without in Utero Exposure to HIV and/or ZIKV
Time frame: Infant Birth, 3 months, 6 months, 12 months
Weight as a measure of growth. Note there were no women with ZIKV infection in pregnancy.
Length and Head Circumference Among Children With and Without in Utero Exposure to HIV and/or ZIKV
Time frame: Infant Birth, 3 months, 6 months, 12 months
Length and head circumference as measures of growth. Note there were no women with ZIKV infection in pregnancy.
Audiologic Function Among Children With or Without in Utero Exposure to HIV and/or ZIKV
Time frame: Within one month of infant birth, 3 months, 6 months, 12 months
Audiologic function as assessed by OAE test reported. Note there were no women with ZIKV infection in pregnancy.
Ophthalmologic Structure and Function Among Children With or Without in Utero Exposure to HIV and/or ZIKV
Time frame: Within one month of infant birth, 12 months;
Ocular abnormalities included both structural and functional ophthalmologic abnormalities. Note there were no women with ZIKV infection in pregnancy.
Neurodevelopment Among Children With or Without in Utero Exposure to HIV and/or ZIKV
Time frame: Infant 3 months, 6 months, 12 months
Infant neurodevelopment was assessed by either the Bayley III or Ages and Stages Questionnaires- 3rd Edition. Combined results reported. Note there were no women with ZIKV infection in pregnancy.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marisa M. Mussi-Pinhata, MD study chair
University of Sao Paolo, Riberao Preto Medical School, Department of Pediatrics
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and Zika Virus, run by Westat at 11 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Brazil, United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2022.