CompletedNCT03263195HIV ZIPUpdated Jan 14, 2022Results posted

Prospective Cohort Study of HIV and Zika in Infants and Pregnancy

An observational study in HIV, Zika Virus and Pregnant Women, sponsored by Westat. Completed at 11 sites in 3 countries. Open to female participants aged 15 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-14.

Sponsored by Westat · Observational

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 395
Ages: 15 Years and older
Sex: Female

Study 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.

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 studied

HIV
Zika Virus
Pregnant Women

Browse trials for

Zika Virus Infection 63

Keywords

HIV
Zika Virus
Pregnancy
MTCT

Who can participate

Ages eligible: 15 Years and older
Sexes eligible: Female
Accepts healthy volunteers: Yes
Sampling method: Non-probability sample

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

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

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.

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 395 participants (actual)
Patient registry: No
Biospecimen retention: Samples with dna

Groups and cohorts

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 researchers measure

Primary outcomes

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
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Infant 3 months, 6 months, 12 months

Results

Posted Jan 14, 2022

Participant flow

Participant flow — Overall Study
Milestone	Women With HIV Only	Women Without HIV or ZIKV	Infants of Women With HIV Only	Infants of Women Without HIV or ZIKV
Started	174	26	170	25
Completed	168	23	155	19
Not completed	6	3	15	6

Outcome measures

PrimaryEnrollment (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

Time frame:: At the time of delivery of all those enrolled up to 1 year after the first enrollment
Reported as:: Count of participants · Participants

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).
Participants	Women With HIV Only	Women With ZIKV Only	Women With HIV and ZIKV	Women Without HIV or ZIKV
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).	174	0	0	26

PrimaryViral 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).

Time frame:: Maternal viral load at delivery
Reported as:: Count of participants · Participants

Viral Suppression (in HIV-infected Women With ZIKV Co-infection Compared to Those Without ZIKV Co-infection During Pregnancy) at the Time of Delivery.
Participants	Women With HIV Only	Women With HIV and ZIKV
VL <40 copies/mL — Yes	101	—
VL <40 copies/mL — No	22	—
VL <40 copies/mL — Missing	51	—
VL <400 copies/mL — Yes	110	—
VL <400 copies/mL — No	13	—
VL <400 copies/mL — Missing	51	—
VL <1000 copies/mL — Yes	111	—
VL <1000 copies/mL — No	12	—
VL <1000 copies/mL — Missing	51	—

PrimaryIncidence 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).

Time frame:: Maternal baseline to delivery
Reported as:: Count of participants · Participants

Incidence of ZIKV Infection (Among Pregnant Women With HIV Infection Compared to Those Without HIV Infection).
Participants	Women With HIV	Women Without HIV
Incidence of ZIKV Infection (Among Pregnant Women With HIV Infection Compared to Those Without HIV Infection).	0	0

PrimaryIncidence 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.

Time frame:: At time of delivery
Reported as:: Count of participants · Participants

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).
Participants	Women With HIV Only	Women With ZIKV Only	Women With HIV and ZIKV	Women Without HIV or ZIKV
Miscarriage	3	—	—	0
Stillbirth	1	—	—	0
Preterm delivery	16	—	—	1

PrimaryIncidence 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.

Time frame:: Infant birth to 12 months
Reported as:: Count of participants · Participants

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).
Participants	Infants of Women With HIV Only	Infants of Women With ZIKV Only	Infants of Women With HIV and ZIKV
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).	0	—	—

PrimaryIncidence 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.

Time frame:: Infant birth, 3 months
Reported as:: Count of participants · Participants

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).
Participants	Infants of Women With HIV Only	Infants of Women With ZIKV Only	Infants of Women With HIV and ZIKV	Infants of Women Without HIV or ZIKV
Major malformations	6	—	—	2
Minor malformations	32	—	—	5

PrimaryIncidence 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.

Time frame:: Infant birth to 12 months
Reported as:: Count of participants · Participants

Incidence of Other Adverse Outcomes Among Offspring of Women Co-infected With HIV and ZIKV, Women Infected With Either HIV or ZIKV Alone.
Participants	Infants of Women With HIV Only	Infants of Women With ZIKV Only	Infants of Women With HIV and ZIKV	Infants of Women Without HIV or ZIKV
Microcephaly	0	—	—	0
Neonatal death	1	—	—	0
CNS malformations	0	—	—	1
Hydrops	2	—	—	0
Ocular abnormalities	18	—	—	5

PrimaryWeight 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.

Time frame:: Infant Birth, 3 months, 6 months, 12 months
Reported as:: Median · kg

Weight Among Children With or Without in Utero Exposure to HIV and/or ZIKV
kg	Infants of Women With HIV Only	Infants of Women With ZIKV Only	Infants of Women With HIV and ZIKV	Infants of Women Without HIV or ZIKV
Weight at birth	3.2 (2.8 to 3.4)	—	—	3.2 (2.9 to 3.7)
Weight at 3 months	5.9 (5.4 to 6.6)	—	—	5.7 (5.3 to 6.4)
Weight at 6 months	7.7 (7.0 to 8.4)	—	—	8.2 (7.0 to 9.0)
Weight at 12 months	10.0 (9.0 to 10.7)	—	—	9.8 (8.8 to 10.9)

PrimaryLength 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.

Time frame:: Infant Birth, 3 months, 6 months, 12 months
Reported as:: Median · cm

Length and Head Circumference Among Children With and Without in Utero Exposure to HIV and/or ZIKV
cm	Infants of Women With HIV Only	Infants of Women With ZIKV Only	Infants of Women With HIV and ZIKV	Infants of Women Without HIV or ZIKV
Length at birth	48.2 (47.0 to 50.0)	—	—	48.3 (46.9 to 52.0)
Length at 3 months	58.5 (57.0 to 60.5)	—	—	59.5 (55.8 to 61.0)
Length at 6 months	65.0 (64.0 to 67.0)	—	—	67.0 (62.0 to 69.5)
Length at 12 months	75.0 (73.0 to 77.5)	—	—	74.2 (71.5 to 77.2)
Head circumference at birth	34.0 (33.0 to 35.0)	—	—	34.0 (33.0 to 35.0)
Head circumference at 3 months	40.0 (39.0 to 41.0)	—	—	40.3 (39.0 to 41.0)
Head circumference at 6 months	43.0 (42.0 to 44.0)	—	—	43.8 (43.0 to 44.2)
Head circumference at 12 months	46.0 (45.0 to 47.0)	—	—	46.3 (45.5 to 47.0)

PrimaryAudiologic 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.

Time frame:: Within one month of infant birth, 3 months, 6 months, 12 months
Reported as:: Count of participants · Participants

Audiologic Function Among Children With or Without in Utero Exposure to HIV and/or ZIKV
Participants	Infants of Women With HIV Only	Infants of Women With ZIKV Only	Infants of Women With HIV and ZIKV	Infants of Women Without HIV or ZIKV
Right ear (Birth) — Passed	112	—	—	3
Right ear (Birth) — Failed	12	—	—	0
Right ear (Birth) — Test result not available	46	—	—	22
Right ear (3 months) — Passed	99	—	—	17
Right ear (3 months) — Failed	11	—	—	1
Right ear (3 months) — Test result not available	60	—	—	7
Right ear (6 months) — Passed	102	—	—	14
Right ear (6 months) — Failed	21	—	—	1
Right ear (6 months) — Test result not available	47	—	—	10
Right ear (12 months) — Passed	84	—	—	13
Right ear (12 months) — Failed	20	—	—	2
Right ear (12 months) — Test result not available	66	—	—	10
Left ear (Birth) — Passed	108	—	—	3
Left ear (Birth) — Failed	16	—	—	0
Left ear (Birth) — Test result not available	46	—	—	22
Left ear (3 months) — Passed	100	—	—	17
Left ear (3 months) — Failed	10	—	—	1
Left ear (3 months) — Test result not available	60	—	—	7
Left ear (6 months) — Passed	103	—	—	14
Left ear (6 months) — Failed	20	—	—	1
Left ear (6 months) — Test result not available	47	—	—	10
Left ear (12 months) — Passed	84	—	—	13
Left ear (12 months) — Failed	21	—	—	2
Left ear (12 months) — Test result not available	65	—	—	10

PrimaryOphthalmologic 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.

Time frame:: Within one month of infant birth, 12 months;
Reported as:: Count of participants · Participants

Ophthalmologic Structure and Function Among Children With or Without in Utero Exposure to HIV and/or ZIKV
Participants	Infants of Women With HIV Only	Infants of Women With ZIKV Only	Infants of Women With HIV and ZIKV	Infants of Women Without HIV or ZIKV
Ocular abnormalities	18	—	—	5
No ocular abnormalities	152	—	—	20

PrimaryNeurodevelopment 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.

Time frame:: Infant 3 months, 6 months, 12 months
Reported as:: Count of participants · Participants

Neurodevelopment Among Children With or Without in Utero Exposure to HIV and/or ZIKV
Participants	Infants of Women With HIV Only	Infants of Women With ZIKV Only	Infants of Women With HIV and ZIKV	Infants of Women Without HIV or ZIKV
Failed screening test at 3 months — Yes	2	—	—	2
Failed screening test at 3 months — No	159	—	—	20
Failed screening test at 3 months — Missing	9	—	—	3
Failed screening test at 6 months — Yes	2	—	—	0
Failed screening test at 6 months — No	154	—	—	17
Failed screening test at 6 months — Missing	14	—	—	8
Failed screening test at 12 months — Yes	3	—	—	0
Failed screening test at 12 months — No	134	—	—	16
Failed screening test at 12 months — Missing	33	—	—	9

Adverse events

Collected over Through study completion, up to 1 year of follow-up of live-born infant.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Women With HIV Only	1/174 (0.6%)	0/174 (0%)	0/174 (0%)
Women With ZIKV Only	—	—	—
Women With HIV and ZIKV	—	—	—
Women Without HIV or ZIKV	0/26 (0%)	0/26 (0%)	0/26 (0%)
Infants of Women With HIV Only	2/170 (1.2%)	0/170 (0%)	0/170 (0%)
Infants of Women With ZIKV Only	—	—	—
Infants of Women With HIV and ZIKV	—	—	—
Infants of Women Without HIV or ZIKV	0/25 (0%)	0/25 (0%)	0/25 (0%)

Baseline characteristics

At baseline (start of study) pregnant women were enrolled. Baseline characteristics of these women enrolled during pregnancy are therefore presented in this table. Live-born infants of these women were subsequently followed for one year if consent was obtained.

Age, Continuous
Age, Continuous(years)	Women With HIV Only	Women With ZIKV Only	Women With HIV and ZIKV	Women Without HIV or ZIKV	Total
Median	28.2 (23.2 to 32.9)	—	—	29.2 (23.9 to 32.7)	28.3 (23.2 to 32.8)

Sex: Female, Male
Sex: Female, Male(Participants)	Women With HIV Only	Women With ZIKV Only	Women With HIV and ZIKV	Women Without HIV or ZIKV	Total
Female	174	—	—	26	200
Male	0	—	—	0	0

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Women With HIV Only	Women Without HIV or ZIKV	Total
White (US)	4	6	10
Black (US)	2	6	8
Asian (US)	0	2	2
More than one race (US)	1	2	3
Other (US)	0	3	3
Not reported (US)	3	7	10
White (Brazil)	39	0	39
Black (Brazil)	40	0	40
Mulatto (Brazil)	8	0	8
Amarela/Yellow (Brazil)	1	0	1
Indigenous (Brazil)	2	0	2
Mixed Black (Brazil)	51	0	51
More than one race (Brazil)	21	0	21

Region of Enrollment
Region of Enrollment(participants)	Women With HIV Only	Women With ZIKV Only	Women With HIV and ZIKV	Women Without HIV or ZIKV	Total
Puerto Rico	9	—	—	0	9
United States	1	—	—	26	27
Brazil	164	—	—	0	164

Gestational age at enrollment
Gestational age at enrollment(weeks)	Women With HIV Only	Women With ZIKV Only	Women With HIV and ZIKV	Women Without HIV or ZIKV	Total
Median	14.5 (12.0 to 16.0)	—	—	16.0 (14.0 to 17.0)	15.0 (12.0 to 16.0)

Study locations

11 sites

University of Miami Pediatric/Prenatal HIV/AIDS
Miami, Florida 33146, United States
Bronx-Lebanon Hospital Center NICHD CRS
Bronx, New York 10457, United States
Baylor College of Medicine; Texas Children's Hospital
Houston, Texas 77030, United States
Baylor College of Medicine
Houston, Texas 77030, United States
SOM Federal University Minas Gerais Brazil NICHD CRS
Belo Horizonte, Minas Gerais 30.130-100, Brazil
Hospital Federal dos Servidores do Estado NICHD CRS
Rio de Janeiro, 20221-903, Brazil
Instituto de Puericultura e Pediatria Martagao Gesteira - UFRJ NICHD CRS
Rio de Janeiro, 21941-612, Brazil
Hosp. Geral De Nova Igaucu Brazil NICHD CRS
Rio de Janeiro, 26030, Brazil
University of Sao Paulo at Riberaio Preto Brazil
São Paulo, 14049-900, Brazil
University of Puerto Rico Pediatrics HIV/AIDS Research Program
San Juan, 00936-5067, Puerto Rico
San Juan City Hosp. PR NICHD CRS
San Juan, 00936, Puerto Rico

References and documents

Study documents

Protocol and statistical analysis plan · Mar 20, 2017
Informed consent form · Mar 20, 2017
Informed consent form · Mar 20, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Icf, Csr

Registry details

Key details

Study ID: NCT03263195
Lead sponsor: Westat
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Allergy and Infectious Diseases (NIAID)
Responsible party: Sponsor
First posted: Aug 28, 2017
Start date: Aug 23, 2017
Primary completion: Sep 30, 2020
Completion: Sep 30, 2020
Results posted: Jan 14, 2022
Last update: Jan 14, 2022

Study contacts

Marisa M. Mussi-Pinhata, MD

study chair · University of Sao Paolo, Riberao Preto Medical School, Department of Pediatrics

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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