Growth and Development Clinical Trial
Official title:
Promoting Infant Health and Nutrition in Sub-Saharan Africa (PROMISE): Safety and Efficacy of Infant Peri-Exposure Prophylaxis (PEP) to Prevent HIV-1 Transmission by Breastfeeding Mechanisms & Safety (M&S)
General objective
- To assess the long-term safety and efficacy of one-year infant prophylaxis using
lamivudine (3TC) or lopinavir/ritonavir (LPV/r) to prevent post-natal transmission
through breastfeeding.
- To investigate the biological mechanisms involved in postnatal HIV transmission.
Specific objectives
- To compare the long-term safety of infant prophylaxis using either 3TC versus LPV/r on
child development (growth, somatic and mental health), mortality, adrenal function,
liver function, full blood count and mitochondrial toxicity.
- To estimate the final efficacy data of 50 weeks of infant prophylaxis using either LPV/r
or 3TC, since some mothers may have resumed breastfeeding after the trial.
- To profile miRNA in breast milk according to maternal HIV status and HIV transmission.
- To determine the influence of maternal milk on infant gut inflammation in an in vitro
3D-intestinal model (CACO-2 cells).
The study population will comprise all ANRS 12174 PROMISE-PEP trial participants who
completed the 50 week follow-up and are not HIV infected. An estimate of 881 mother-child
pairs from the ANRS 12174 PROMISE- PEP will be recruited.
This study is structured in two parts. The 'clinical & biological safety' component involves
a cross sectional survey. A clinical and neuropsychological examination of participants will
be conducted. In addition one venous blood sample will be collected to evaluate children HIV
status, full blood count, liver & adrenal function and mitochondrial toxicity. Capillary hair
follicles will be collected from 100 children in Zambia to study their genome integrity.
The 'mechanisms' component includes biological assays to be conducted on breast milk samples
previously collected from HIV infected, transmitting or non-infected mothers enrolled at ANRS
12174 PROMISE-PEP trial.
Primary endpoint: Long term survival, mortality rate, measurements of infant growth (length
and weight), somatic and neuropsychological development of the 5 year old children enrolled
in the ANRS 12174 PROMISE- PEP trial.
Secondary endpoints: HIV seroconversion since last PROMISE PEP trial visit, full blood count,
liver function, adrenal function, serum lactate. Number of mitochondrial DNA copies per cell
& percentage of mitochondrial DNA deletion for mitochondrial toxicity. Number of micronuclei
& number of Ɣ-tubulin spot per cell to study genomic toxicity.
Status | Completed |
Enrollment | 562 |
Est. completion date | February 15, 2018 |
Est. primary completion date | February 13, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years to 8 Years |
Eligibility |
Inclusion Criteria: - Having taken part in the ANRS 12174 PROMISE-PEP trial until the final (50 week) visit; - Not being infected with HIV during the duration of the ANRS 12174 PROMISE-PEP trial. Exclusion Criteria: - Parent refusal to participate in the study after information about the PROMISE M&S project is given. |
Country | Name | City | State |
---|---|---|---|
Burkina Faso | Centre Hospitalier Universitaire Blaise Compraore | Ouagadougou | |
South Africa | Cecilia Makiwane hospital | East London | |
Uganda | PROMISE M&S site | Mbale | |
Zambia | Paediatric Center Of Excellence | Lusaka |
Lead Sponsor | Collaborator |
---|---|
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) |
Burkina Faso, South Africa, Uganda, Zambia,
Heidari S, Mofenson L, Cotton MF, Marlink R, Cahn P, Katabira E. Antiretroviral drugs for preventing mother-to-child transmission of HIV: a review of potential effects on HIV-exposed but uninfected children. J Acquir Immune Defic Syndr. 2011 Aug 1;57(4):290-6. doi: 10.1097/QAI.0b013e318221c56a. Review. — View Citation
Nagot N, Kankasa C, Tumwine JK, Meda N, Hofmeyr GJ, Vallo R, Mwiya M, Kwagala M, Traore H, Sunday A, Singata M, Siuluta C, Some E, Rutagwera D, Neboua D, Ndeezi G, Jackson D, Maréchal V, Neveu D, Engebretsen IMS, Lombard C, Blanche S, Sommerfelt H, Rekacewicz C, Tylleskär T, Van de Perre P; ANRS 12174 Trial Group. Extended pre-exposure prophylaxis with lopinavir-ritonavir versus lamivudine to prevent HIV-1 transmission through breastfeeding up to 50 weeks in infants in Africa (ANRS 12174): a randomised controlled trial. Lancet. 2016 Feb 6;387(10018):566-573. doi: 10.1016/S0140-6736(15)00984-8. Epub 2015 Nov 19. Erratum in: Lancet. 2019 Jun 22;393(10190):2492. — View Citation
Van de Perre P, Rubbo PA, Viljoen J, Nagot N, Tylleskär T, Lepage P, Vendrell JP, Tuaillon E. HIV-1 reservoirs in breast milk and challenges to elimination of breast-feeding transmission of HIV-1. Sci Transl Med. 2012 Jul 18;4(143):143sr3. doi: 10.1126/scitranslmed.3003327. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Mitochondrial toxicity | Number of mitochondrial DNA copies per cell | Cross-sectional survey during the inclusion visit | |
Other | Mitochondrial toxicity | Percentage of mitochondrial DNA deletion | Cross-sectional survey during the inclusion visit | |
Other | Genome integrity | Number of micronuclei | Cross-sectional survey during the inclusion visit | |
Other | Genome integrity | Number of ?-tubulin spot per cell | Cross-sectional survey during the inclusion visit | |
Primary | HIV seroconversion | Number of children with positive HIV test | From date of last visit in PROMISE PEP study (week 50 of follow-up) until the date of PROMISE-PEP M&S inclusion visit, assessed up to 96 months | |
Secondary | Long term survival | Time to death | From date of last visit in PROMISE PEP study (week 50 of follow-up) until the date of first documented date of death from any cause, assessed up to 96 months | |
Secondary | Mortality rate | Number of deaths | From date of last visit in PROMISE PEP study (week 50 of follow-up) until the date of first documented date of death from any cause, assessed up to 96 months | |
Secondary | Height | measured in centimeters | Cross-sectional survey during the inclusion visit | |
Secondary | Weight | measured in kilograms | Cross-sectional survey during the inclusion visit | |
Secondary | Infant growth | weight-for-height, height for age, weight for age and body mass index for age measured by Z-scores | Cross-sectional survey during the inclusion visit | |
Secondary | Neuro-psychological development | Development measured by M-ABC2, KABC-II, SDQ25 and TOVA-visual total standard test scores, percentiles, age specific norms and standard deviations. | Cross-sectional survey during the inclusion visit | |
Secondary | Biological disorders | Number of children with normal full blood count | Cross-sectional survey during the inclusion visit | |
Secondary | Biological disorders | Number of children with normal liver function tests | Cross-sectional survey during the inclusion visit | |
Secondary | Biological disorders | Number of children with normal functioning of adrenal glands | Cross-sectional survey during the inclusion visit | |
Secondary | Biological disorders | Number of children with normal serum lactate levels | Cross-sectional survey during the inclusion visit |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05370989 -
Technology-Based Parent School Program
|
N/A | |
Recruiting |
NCT05138276 -
Effect of Autologous Cord Blood Mononuclear Cells for Digestive System in Preterm Neonates
|
Early Phase 1 | |
Completed |
NCT02345187 -
fMRI Study to Investigate Hemodynamic Changes in Brain Resulting From Supplementation of Bacopa Monnieri Extract and Multiple Micronutrient Supplementation.
|
N/A | |
Completed |
NCT04624347 -
NEOVIDEO : Impact of Monitoring Motor Activity by Video Analysis on the Sleep of Very Preterm Infants
|
N/A | |
Completed |
NCT03155269 -
To Investigate the Impact of a Nutritional Supplement on Bone Turnover Markers in Indian Healthy Premenopausal Women (25- 45 Years) After 6 Months of Intervention
|
N/A | |
Completed |
NCT02437721 -
Suitability of an Infant Formula With L-5-Methyltetrahydrofolate for the Particular Nutritional Use in Infants
|
N/A | |
Completed |
NCT02428699 -
Study Comparing Blood Levels of Fatty Acids After Consuming Two Forms of Cod Liver Oil
|
N/A | |
Completed |
NCT02428127 -
Efficacy of a Carbohydrate Drink on Speed, Agility and Power in School Going Children
|
N/A | |
Completed |
NCT03395015 -
Efficacy of Maxillo-facial Treatment on Cleft Lip and Palate Patients Faces: Aesthetic Considerations
|
N/A | |
Withdrawn |
NCT02551627 -
A Study to Investigate the Impact of a Multiple Micronutrient (MMN) Beverage Powder on Vaccine Response in School Children
|
N/A | |
Completed |
NCT02542865 -
A Study to Investigate the Impact of Fortified Malt Based on Immunity Outcomes in School Children
|
N/A | |
Completed |
NCT02805192 -
Validation of a Smart Phone App to Non-invasively Measure the Size of Children
|
N/A | |
Active, not recruiting |
NCT03099837 -
Tongji Maternal and Child Health Cohort
|
||
Completed |
NCT02254460 -
Investigation of Iron Uptake From Micronutrient Fortified Powder Versus From Tailored Control in Milk
|
N/A | |
Completed |
NCT02338609 -
Long-term Follow-up for Growth and Development of Pediatric Patients From CRAD001M2301
|
Phase 4 | |
Recruiting |
NCT05868408 -
Effect of Partially Hydrolyzed, Whey-based Infant Formulas on Growth and Tolerability in Healthy Term Infants
|
N/A |