NCT02421302

Brief Summary

This will be cohort study design with both qualitative and quantitative methods of data collection. The investigators are aiming to study 64 HIV positive children as healthy controls either initiating ART or already on ART and 86 malnourished HIV infected children on ART or naïve initiating ART and RUTF aged between 6 months to 12 years. Primary carers will be asked to provide informed consent whereby the children and primary carers will be enrolled into the study and followed up for 12 weeks.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 20, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

April 20, 2015

Status Verified

April 1, 2015

Enrollment Period

10 months

First QC Date

February 18, 2015

Last Update Submit

April 15, 2015

Conditions

Child Nutrition Disorders

Outcome Measures

Primary Outcomes (1)

  • Changes in numbers of circulating immune cell population and their capacity to release cytokines

    Immune response

    12 weeks

Secondary Outcomes (5)

  • Occurrence of Immune reconstitution inflammatory syndrome (IRIS)

    12 weeks

  • Occurrence of re-feeding syndrome

    12 weeks

  • Pharmacological: Cmax

    12 weeks

  • Pharmacological: AUC

    12 weeks

  • Number of participants with adverse events

    12 weeks

Study Arms (3)

Well-nourished HIV+ ART naive

NO INTERVENTION

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

Moderately-malnourished HIV+; RUTF

ACTIVE COMPARATOR

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

Dietary Supplement: RUTF

Severely acute-malnourished HIV+; RUTF

ACTIVE COMPARATOR

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

Dietary Supplement: RUTF

Interventions

RUTFDIETARY_SUPPLEMENT

This is ready-to-use-therapeutic-food

Also known as: Ready-to-Use-Therapeutic-Food
Moderately-malnourished HIV+; RUTFSeverely acute-malnourished HIV+; RUTF

Eligibility Criteria

Age6 Months - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • HIV-infected children aged 6 months to 12 years, including Well Nourished (WN), Moderately Acute Malnutrition (MAM) and Severe Acute Malnutrition (SAM) patients initiating on ART within 2 weeks, whose carer is aged ≥18 years and has provided informed consent.
  • 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.

You may not qualify if:

  • Previous enrollment in a nutritional therapeutic program in the last 3 months
  • Children involved in an on-going nutrition study
  • Children who have previously received the tuberculin skin test (TST) or mantoux or purified protein derivative (PPD) in the last 3 months.
  • Children with clinically suspected or confirmed malignancy
  • Children exhibiting any specific food intolerance
  • Children who are vomiting profusely (over 3 times daily)
  • Children living outside 50 km radius from Infectious Diseases Institute at Mulago, Kampala
  • Children whose carers do not want to disclose their home address.
  • Children whose cause of malnutrition is compounded by congenital malformations, chromosomal disorders, metabolic disorders, congenital immune disorders, cerebral palsy
  • Children with a severe disability limiting the possibility of investigations
  • Children who plan to leave the catchment area in the next 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Infectious Diseases Institute

Kampala, Kampala, 256, Uganda

RECRUITING

Mildmay International Centre Kampala

Kampala, Kampala, 256, Uganda

RECRUITING

MeSH Terms

Conditions

Child Nutrition Disorders

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Judy Orikiiriza, MMED

    PhD Candidate

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Judy Orikiiriza, MMED

CONTACT

+256312307000jorikiiriza@idi.co.ug

Allen M Mukhwana, MBA

CONTACT

+256312307000amukhwana@idi.co.ug

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD Candidate

Study Record Dates

First Submitted

February 18, 2015

First Posted

April 20, 2015

Study Start

February 1, 2015

Primary Completion

December 1, 2015

Study Completion

April 1, 2016

Last Updated

April 20, 2015

Record last verified: 2015-04

Locations

UG(2)