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NCT04763668: ARTMOMSBABES

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

Status unknown Last updated 6 May 2021
What this trial tests

trial testing Pregnant HIV positive women on ARTs in In Utero Drug Exposure in 320 participants. Status unknown.

Timeline
20 May 2021
Primary endpoint
31 December 2021
31 December 2023

Quick facts

Lead sponsorWalter Sisulu University
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment320
Start date20 May 2021
Primary completion31 December 2021
Estimated completion31 December 2023
Sites1 location across South Africa

Drugs / interventions tested

Conditions studied

Sponsor

Walter Sisulu University

Who can join

Eligibility, female only, with In Utero Drug Exposure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Assessment of the impact of HIV infection and anti-retroviral treatment on the cardiometabolic health of pregnant mothers and their offspring (ARTMOMSBABES).
    Nkeh-Chungag BN, Engwa GA, Businge C, Mdondolo M, et al · · 2021 · cited 5× · PMID 34193034 · DOI 10.1186/s12872-021-02130-2

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