1,200 pregnant women (600 HIV+ mothers and 600 HIV-controls) in their third trimester were enrolled from January 2016 to June 2019. Participants are being followed as mother-baby pairs at birth, within 10 days of life 6, 10, 14 24, 48, 72 and 96 weeks of age. At each visit clinical examinations are being used to assess health and the impact of environmental factors. In addition, questionnaires are administered and bio-samples for laboratory tests. The design of the study is non-interventional cohort but participants are being offered advice regarding health and hygiene.

maternal urine, stool, plasma, milk, cord blood, amniotic fluid, placenta, infant serum/plasma, dried blood spots and stool

HIV Infections

Immune Activation

Cormobidities

The University of Zimbabwe College of Health Science (UZ-CHS) BIRTH COHORT Study

HIV Exposure, Disease Acquisition and Progression Among Children: Role of Maternal Immunogenetics, Viral Genetic Diversity, HAART Exposure, Co-morbidities and Psycho-Social Status: (UZ-CHS Birth Cohort)

Comparison of morbidity of HEU vs. HUU infants, defined as impaired growth, immune- and neuro-development and/ or frequent clinically relevant infections

To determine any association of maternal HIV infection, HAART exposure.

To determine any association with maternal HIV and HAART exposure.

To determine any association of HAART exposure in utero and during breast feeding with pregnancy outcome, infant (HUU, HEU, HEI) growth and immune- and neuro-development.

To determine vertical transmission rates for HIV at birth and within the first 2 years of life and assess risk factors for transmission

HIV incidence rate among mother sero-negative at enrollment

To determine the association between maternal baseline and delivery HAART levels in different compartments and the relation of those to infant HIV transmission, mortality and morbidity.

To determine the association between antenatal immune dysregulation and infant death, growth and immune responses to vaccines.

To determine HIV drug resistance profiles in mother and infants unresponsive to HAART

To determine how CMV DNA is influenced by HIV infection, HAART use and as single infection or combined infections in HIV+ and HIV- women and determine the impact on pregnancy outcome and infant cmv vertical transmission

To determine how HBV infection infections in HIV+ and HIV- women and determine the impact on pregnancy outcome, infant vertical transmission

To determine HCV infections proportion in HIV positives and negatives and HIV+ and HIV- women and determine the impact on pregnancy outcome, infant incidence of congenital cmv infection

To determine syphilis infections proportion in HIV positives and negatives and the impact on pregnancy outcome, infant incidence of congenital syphilis infection

To determine the prevalence of helminthes infection using 18s sequencing and correlate with infant development of atopic dermatitis.

To determine the prevalence of maternal under and overnutrition using BMI and MUAC impact on pregnancy outcomes, infant mortality and morbidity.

To assess abnormalities in HIV + and HIV- including lipid profiles, bone, haematological (anemia) and hepatic toxicities associated with exposure to HAART among mothers and infants.

To determine infant non-infectious comorbidities (e.g. anaemia, atopic dermatitis, congenital infections and other conditions) and their impact on mortality and morbidity.

To assess delayed neuro-cognitive development using the Denver II tool in HUU, HEU and HEI infants and correlated with socio economic status and infectious diseases.

To determine humoural immune responses to EPI vaccines including antibody levels against measles, tetanus, diphtheria, pertussis, polio and rotavirus) in HUU, HEU and HEI infants.

To determine immune activation and systemic inflammatory biomarkers in HUU, HEU and HEI infants

To determine biomarkers for endothelial dysfunction including microbial translocation in HUU, HEU and HEI infants and association with household hygiene at delivery, 6, 48 and 96 weeks of age.

To determine antenatal reference ranges for MUAC, haemoglobin from FBC analyses, and biochemistry (kidney function, liver function tests, bone, lipid profiles) in mothers with a favourable outcome of pregnancy

To determine maternal- infant microbiota16S sequencing in pregnancy and relate it to infant immune development and atopy (anti-inflammatory (IL-4, -5, -13) and regulatory cytokines (IL-10, TGF-β) at delivery, 6 weeks 48 and 96 weeks of age.

Bacterial full genome metagenomics shotgun sequencing to identify the microbiota metabolic potential (i.e. bacterial genes present will be done) and mass spectrometry will be performed for analysis of small intestinal content (metabolome).

Wide range of nutritional profiles and HAART levels spectrometry will be performed for analysis of at least 700 metabolites including amino acids and lipids will be performed in plasma, breast milk and stool samples

To characterize pathogen genetic diversity including HIV, HBV, HCV, CMV subtypes, prevalent in our study population at time of infection

To determine host genetic markers for infectious disease susceptibility including human leukocyte antigen (HLA) and killer immunoglobulin like receptor (KIR) gene variants and their association with infection rates of HIV and co-infections in mothers and their infants.

Only anonymous data will be stored at local sites and transferred between sites for collaborative research efforts. All original data will be stored locally at the UZ-CHS for at least 10 years on suitable electronic devices. Data transfer with collaborating partners will be encrypted. using EGAcryptor. With our European partners we will follow the current European General Data Protection Regulation effective May 25, 2018.

Kerina Duri

Associate Professor

University of Zimbabwe

University Hospital Inselspital, Berne

University of Hamburg

University of Oxford

Wellcome Trust

University of Yaounde

University of Cape Town

Midlands State University, Zimbabwe

National Institute of Health Research, Zimbabwe

intravenous infusion of furosemide (doses 125-250mg⁄ bid) from the first day after admission until 3 days before discharge Intervention: drug: furosemide ; other name: lasix

small volumes of hypertonic saline solutions (HSS) (150mL 1.4-4.6% NaCl), from the first day after admission until 3 days before discharge Intervention: Hypertonic saline solutions (1.4-4.6%NaCl) Intervention other name: not specified

no intervention Intervention: no drug only seriated paracentesis repeated paracentesis from the first day after admission until 3 days before discharge

Ascites

Cirrhosis

treatment with intravenous infusion of furosemide (doses 125-250mg⁄ bid) plus small volumes of HSS (150mL 1.4-4.6% NaCl), from the first day after admission until 3 days before discharge, with water restriction and a normal sodium diet.

intravenous furosemide

Intravenous small volumes of HSS (150mL 1.4-4.6% NaCl), plus treatment with intravenous infusion of furosemide (doses 125-250mg⁄ bid) from the first day after admission until 3 days before discharge, with water restriction and a normal sodium diet.

Hypertonic saline solutions

repeated paracentesis from the first day after admission until 3 days before discharge

Seriated paracentesis

Antonino Tuttolomondo

Internal Medicine Ward of Palermo University Hospital

Internal Medicine Ward, University of Palermo

Metabolic Effects of Furosemide +HSS in Refractory Ascites

Immune-inflammatory and Metabolic Effects of High Dose Furosemide Plus Hypertonic Saline Solution (HSS) Treatment in Cirrhotic Subjects With Refractory Ascite

difference between ANP serum levels at admission and ANP serum levels at discharge.

difference between BNP serum levels at admission and BNP serum levels at discharge.

difference between IL-1 beta serum levels at admission and IL-1 beta serum levels

difference between serum visfatin at admission and serum visfatin at discharge.

difference between serum leptin at admission and serum leptin at discharge.

difference between serum TNF-alfa at admission and serum TNF-alfa at discharge.

difference between serum IL-6 at admission and serum Il-6 at discharge.

MD, PhD, Associate Professor

University of Palermo

Liver transplant recipients who receive induction with rATG prior to transplantation.

Liver transplant recipients who do not receive rATG induction therapy prior to transplantation.

Liver Transplantation

Thymoglobulin

Rejection

Children's Hospital of Pittsburgh of UPMC

rATG Induction and Tacrolimus Monotherapy in Pediatric Liver Transplantation

Pharmacodynamics, Pharmacogenomics, and Preliminary Safety and Efficacy of rATG Induction and Tacrolimus Monotherapy in Pediatric Liver Transplantation

viremia/potasio

The University of Zimbabwe College of Health Science (UZ-CHS) BIRTH COHORT Study

Metabolic Effects of Furosemide +HSS in Refractory Ascites

rATG Induction and Tacrolimus Monotherapy in Pediatric Liver Transplantation

Pender Assisted Therapy (PATh) - Prospective Study of the Treatment of HCV

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