Participants in this arm will have a switch from a protease inhibitor based second line regimen to Dolutegravir maintaining the same NRTI backbone

Participants in this arm will be maintained on their protease inhibitor based second line regimen

HIV-1-infection

Switch of virally suppressed participants to Dolutegravir

Dolutegravir

Kiambu Level 5 Hospital

Jaramogi Oginga Odinga Teaching and Referral Hospital

Kenyatta National Hospital

Thika Level 5 Hospital

Second-line Switch to Dolutegravir Study

Switching Treatment-Experienced, Integrase Inhibitor-Naïve, Virally Suppressed HIV-1 Infected Adults From Ritonavir Boosted Protease Inhibitors to Dolutegravir: An Open-Label Randomized Controlled Trial

Proportion of participants with HIV-1 RNA ≥ 50 copies/ml at week 48 (by US Food and Drug Administration snapshot algorithm, modified to allow for changes in NRTIs for clinical reasons)

Proportion of participants with HIV-1 RNA ≥ 50 copies/ml at week 24

Proportion of participants able to maintain virological suppression (HIV-1 RNA < 50 copies/ml with no discontinuation of the study treatment)

Change in waist circumference from baseline

Change in blood total cholesterol from baseline

Change in low density lipoprotein from baseline

Change in total cholesterol:HDL ratio from baseline

Genotypic resistance mutations for participants with protocol-defined virological failure

HIV Treatment Satisfaction Questionnaire scores. Scores range from 0-60 with higher scores reflecting greater satisfaction with treatment

We will share IPD that underlie the results reported after de-identification (text, tables, figures and appendices)

Loice Achieng

Principal Investigator

University of Nairobi

ViiV Healthcare

Randomised controlled, open label clinical trial

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

Diagnosis of ascites in infants and children by history, examination and investigations

Ascites

Diagnosis of Ascites in Infants and Children

Diagnosis of ascites in infants and children fromega age of 1month to 18 year

Asmaa abo bakr Ahmed

Doctor

Assiut University

blood sampling to measure laboratory parameters useful to asses nutritional status

Food Allergy

university of naples federico II

Nutrition in Children With Food Allergy

Anthropometric indices (z-score for weight, length and head circumference) will be collected at the enrolment (T0) and after 2 (T1), 4 (T2) and 6 months (T3) by experienced nurse unaware to of the study aims. Dietary intake will be assessed by a 3-day diary at T0 and at T3. The nutrient intake will be analyzed using a specific software. The following laboratory measurements will be also analyzed at T0 and at T3: haemoglobin, albumin, total cholesterol, triglycerides, calcium, phosphorus, zinc, fatty acids.

Dietary intake will be assessed by a 3-day diary at T0 and at T3. The nutrient intake will be analyzed using a specific software. The following laboratory measurements will be also analyzed at T0 and at T3: haemoglobin, albumin, total cholesterol, triglycerides, calcium, phosphorus, zinc, fatty acids.

After 12 months of dietotherapy with different formulas tolerance acquisition will be investigated performing a double blind placebo controlled oral food challenge.

tuberculosis/triglyceride

Second-line Switch to Dolutegravir Study

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

Diagnosis of Ascites in Infants and Children

Nutrition in Children With Food Allergy

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