Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
150 participants
INTERVENTIONAL
2015-02-28
2016-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Multiple Micronutrient Supplementation on Growth, Morbidity, and Mortality of HIV Infected Children in Uganda
NCT00122941
Multi-vitamins, HAART and HIV/AIDS in Uganda
NCT01228578
Safety and Metabolic Study of Highly Active Antiretroviral Therapy (HAART) in Malnourished Children With HIV
NCT01529125
Comparison of Treatment Failure Criteria in HIV-Infected Children in Uganda
NCT04489953
Strategies to Reduce Mortality Among HIV-infected and HIV-exposed Children Admitted With Severe Acute Malnutrition
NCT05051163
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
GAP: Clinicians have noted that certain patients deteriorate after starting ART and nutritional supplementation despite viralogical suppression and immunological improvement with a paradoxical emergence of certain opportunistic infections, electrolyte derangement and malnutrition hence IRIS or re-feeding syndrome (RF). There is paucity of data on nutrition as a determinant of immune and pharmacological response amongst HIV infected malnourished children despite malnutrition being common.
HYPOTHESIS: Well-nourished HIV infected children ART naïve or experienced will have a better nutritional, clinical, immunological and pharmacological outcome than malnourished children ART naïve or experienced.
METHODS: A cohort design studying 75 malnourished HIV infected children on ART and RUTF comparing them to 75 well-nourished children ART naive or experienced aged between 6 months to 12 years after primary carers have provided informed consent will be enrolled into the study and followed up for 12 weeks.
IMPACT: This study will endeavor to provide appropriate information that will enhance the management of malnourished HIV infected children in the context of both ART and RUTF and their impact on immune response and drug metabolism. The study will also generate other research questions that need to be addressed in order to optimize HIV services amongst malnourished children.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Well-nourished HIV+ ART naive
These children aged between 6months-12years will be followed up for 12weeks to look at their nutrition, immune and pharmacological responses. They will receive routine nutritional and ART adherence counseling
No interventions assigned to this group
Moderately-malnourished HIV+; RUTF
These children aged between 6months - 12years, ART naive or experienced, will be initiating ready-to-use-therapeutic(RUTF) food and will be followed up for 12 weeks to see the effect of nutrition supplementation on immune and pharmacological responses
RUTF
This is ready-to-use-therapeutic-food
Severely acute-malnourished HIV+; RUTF
These children aged between 6months - 12years, ART naive or experienced, will be initiating ready-to-use-therapeutic(RUTF) food and will be followed up for 12 weeks to see the effect of nutrition supplementation on immune and pharmacological responses
RUTF
This is ready-to-use-therapeutic-food
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
RUTF
This is ready-to-use-therapeutic-food
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Malnourished HIV-infected children aged 6 months to 12 years stabilized on ART for at least 6 months and initiating on RUTF, whose carer is aged ≥18 years and has provided informed consent.
Exclusion Criteria
2. Children involved in an on-going nutrition study
3. Children who have previously received the tuberculin skin test (TST) or mantoux or purified protein derivative (PPD) in the last 3 months.
4. Children with clinically suspected or confirmed malignancy
5. Children exhibiting any specific food intolerance
6. Children who are vomiting profusely (over 3 times daily)
7. Children living outside 50 km radius from Infectious Diseases Institute at Mulago, Kampala
8. Children whose carers do not want to disclose their home address.
9. Children whose cause of malnutrition is compounded by congenital malformations, chromosomal disorders, metabolic disorders, congenital immune disorders, cerebral palsy
10. Children with a severe disability limiting the possibility of investigations
11. Children who plan to leave the catchment area in the next 6 months
6 Months
12 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Dublin, Trinity College
OTHER
Infectious Diseases Institute
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Infectious Diseases Institute
PhD Candidate
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Judy Orikiiriza, MMED
Role: PRINCIPAL_INVESTIGATOR
PhD Candidate
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Infectious Diseases Institute
Kampala, Kampala, Uganda
Mildmay International Centre Kampala
Kampala, Kampala, Uganda
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ST/0110/15
Identifier Type: REGISTRY
Identifier Source: secondary_id
ST/0110/15
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.