Cardiometabolic Health of Children Exposed to Anti-retroviral Therapy (ART) in Utero

NCT04763668 | Unknown DMC

• 1 other identifier: 129245
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

The Human Immunodeficiency Virus (HIV) has been recently linked to increased risk for cardiovascular diseases (CVDs). The prevalence of cardiovascular diseases and its risk factor, hypertension, are very high in African communities especially in the working age group which also happens to have the bulk of young female adults in the reproductive age. Hypertension in African children is becoming a real cause for concern though its etiology remains elusive. Thanks to antiretroviral therapy (ART) use, many more infected persons live long enough to reproduce, consequently, an increasing number of children are being born to mothers who are infected with HIV. Could it be that in utero exposure of these children to HIV/ART contribute in programming them for increased risk for cardiovascular diseases thus making them more vulnerable to hypertension in childhood and adulthood? This study is aimed at exploring the possible association of in utero exposure to the HIV/ART environment and an increased risk for cardiovascular disease.

Conditions

In Utero Drug Exposure

Keywords

ART; neonate; HIV infection; risk; cardiovascular disease; pregnant

Outcome Measures

Primary Outcomes (2)

• Assessment of changes in cardiovascular risk profile during pregnancy in pregnant HIV positive women on ARTs

  Cardiovascular risk will be assessed in pregnant

  March 2021 to March 2022

• Assessment of of CVD risk in offspring of HIV positive mothers on ARTs

  Cardiovascular risk will be assessed in the offspring of HIV positive mothers on ART at three time point: at birth, three, twelve and twenty months after birth.

  March 2021 to March 2022

Study Arms (4)

Pregnant HIV positive women on ART

Sub-Saharan women with singleton uncomplicated 11-14 week old pregnancies at recruitment, HIV positive and have been on ARTs for at least four months before pregnancy. Participants must not have type 2 diabetes, gestational diabetes, renal / cardiovascular diseases or any critical health condition.

Other: Pregnant HIV positive women on ARTs

Pregnant HIV negative women

Sub-Saharan women with singleton uncomplicated 11-14 week old pregnancies at recruitment, HIV negative. Participants must not have type 2 diabetes, gestational diabetes, renal / cardiovascular diseases or any critical health condition.

Other: Pregnant HIV positive women on ARTs

Babies born to HIV positive mothers on ARTs

All babies born to pregnant HIV positive women on ARTs who were in the first arm of the study

Other: Babies born to HIV positive mothers on ARTs

Babies born to HIV negative mothers

All babies born to pregnant HIV negative women who were in the first arm of the study.

Other: Babies born to HIV positive mothers on ARTs

Interventions

Pregnant HIV positive women on ARTs OTHER

Cardiovascular disease risk in pregnant HIV positive women on ARTs

Pregnant HIV negative women; Pregnant HIV positive women on ART

Babies born to HIV positive mothers on ARTs OTHER

cardiovascular disease risk in the offspring of HIV positive mothers on ARTs

Babies born to HIV negative mothers; Babies born to HIV positive mothers on ARTs

Eligibility Criteria

• Gender Eligibility Details: The project with start with pregnant women though later on both male and female offspring will be recruited in the study.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Sub-Saharan pregnant women of African ancestry living in South Africa

You may qualify if:

• Cases: sub-Saharan women with singleton uncomplicated 11-14 week old pregnancies, be HIV positive and have been on ARTs for at least four months before pregnancy.
• Controls: 11-14 week old pregnant HIV negative women.

You may not qualify if:

• Pregnant women with type 2 diabetes, gestational diabetes, renal and cardiovascular diseases or any critical health.

Sponsors & Collaborators

• Walter Sisulu University: lead
• Nelson Mandela Academic Hospital: collaborator
• Umtata General Hospital: collaborator
• Medical University of Graz: collaborator

Study Sites (1)

Umtata General Hospital

Mthatha, Eastern Cape, 5099, South Africa

Location

Related Publications (5)

• Agu CE, Uchendu IK, Nsonwu AC, Okwuosa CN, Achukwu PU. Prevalence and associated risk factors of peripheral artery disease in virologically suppressed HIV-infected individuals on antiretroviral therapy in Kwara state, Nigeria: a cross sectional study. BMC Public Health. 2019 Aug 20;19(1):1143. doi: 10.1186/s12889-019-7496-4.

  PMID: 31429736 BACKGROUND

• Ellins EA, Smith KE, Lennon LT, Papacosta O, Wannamethee SG, Whincup PH, Halcox JP. Arterial pathophysiology and comparison of two devices for pulse wave velocity assessment in elderly men: the British regional heart study. Open Heart. 2017 Dec 17;4(2):e000645. doi: 10.1136/openhrt-2017-000645. eCollection 2017.

  PMID: 29344365 BACKGROUND

• Muntner P, Shimbo D, Carey RM, Charleston JB, Gaillard T, Misra S, Myers MG, Ogedegbe G, Schwartz JE, Townsend RR, Urbina EM, Viera AJ, White WB, Wright JT Jr. Measurement of Blood Pressure in Humans: A Scientific Statement From the American Heart Association. Hypertension. 2019 May;73(5):e35-e66. doi: 10.1161/HYP.0000000000000087.

  PMID: 30827125 BACKGROUND

• Ng KYB, Simpson NAB, Cade JE, Greenwood DC, Mcardle HJ, Ciantar E, Alwan NA. Is infant arterial stiffness associated with maternal blood pressure in pregnancy? Findings from a UK birth cohort (Baby VIP study). PLoS One. 2018 Jul 12;13(7):e0200159. doi: 10.1371/journal.pone.0200159. eCollection 2018.

  PMID: 30001353 BACKGROUND

• Samanta M, Mondal R, Ray S, Sabui TK, Kundu CK, Hazra A, Chatterjee K, Sarkar D. Blood pressure variation with gestational age and birth weight in Indian newborn. J Trop Pediatr. 2015 Jun;61(3):197-205. doi: 10.1093/tropej/fmv019. Epub 2015 Mar 31.

  PMID: 25833095 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum from HIV infected mothers and cord blood of infants will be stored for future studies

MeSH Terms

Conditions

HIV Infections; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2021
• First Posted: February 21, 2021
• Study Start: May 20, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2023
• Last Updated: May 6, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: From March 2021 to December 2030
• Access Criteria: Permission will have to be granted by relevant stakeholders.

Locations

ZA (1)