N/A
N=395
Prospective Cohort Study of HIV and Zika in Infants and Pregnancy
HIV · Zika Virus · Pregnant Women
Bottom Line
View on ClinicalTrials.gov: NCT03263195 ↗Enrolled (actual)
395
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcome: Primary: 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 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- Female
- Sponsor
- Westat
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 | — |
| PRIMARY Viral Suppression (in HIV-infected Women With ZIKV Co-infection Compared to Those Without ZIKV Co-infection During Pregnancy) at the Time of Delivery. |
101; 22; 51; 110; 13; 51 | — |
| PRIMARY Incidence of ZIKV Infection (Among Pregnant Women With HIV Infection Compared to Those Without HIV Infection). |
0; 0 | — |
| PRIMARY 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). |
3; 0; 1; 0; 16; 1 | — |
| PRIMARY 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). |
— | — |
| PRIMARY 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). |
6; 2; 32; 5 | — |
| PRIMARY Incidence of Other Adverse Outcomes Among Offspring of Women Co-infected With HIV and ZIKV, Women Infected With Either HIV or ZIKV Alone. |
0; 0; 1; 0; 0; 1 | — |
| PRIMARY Weight Among Children With or Without in Utero Exposure to HIV and/or ZIKV |
3.2; 3.2; 5.9; 5.7; 7.7; 8.2 | — |
| PRIMARY Length and Head Circumference Among Children With and Without in Utero Exposure to HIV and/or ZIKV |
48.2; 48.3; 58.5; 59.5; 65.0; 67.0 | — |
| PRIMARY Audiologic Function Among Children With or Without in Utero Exposure to HIV and/or ZIKV |
112; 3; 12; 0; 46; 22 | — |
| PRIMARY Ophthalmologic Structure and Function Among Children With or Without in Utero Exposure to HIV and/or ZIKV |
18; 5; 152; 20 | — |
| PRIMARY Neurodevelopment Among Children With or Without in Utero Exposure to HIV and/or ZIKV |
2; 2; 159; 20; 9; 3 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03263195). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.