Clinical Trial: The Pediatric HIV Nutrition Study in Uganda

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: The Role of Nutrition as a Determinant of Immune Function and Pharmacological Outcome Amongst HIV Infected Malnourished Children in Uganda

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.

Detailed Summary:

BACKGROUND: Malnutrition and Human Immunodeficiency Virus (HIV) infection are intimately linked and present a serious health challenge in Africa. Approximately 30-50% of children in Uganda with severe acute malnutrition (SAM) are HIV infected. Studies on nutrition as a determinant of immune response and drug metabolism in malnourished children are unknown.

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
Sponsor: Infectious Diseases Institute

Current Primary Outcome: Changes in numbers of circulating immune cell population and their capacity to release cytokines [ Time Frame: 12 weeks ]

Immune response


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Occurrence of Immune reconstitution inflammatory syndrome (IRIS) [ Time Frame: 12 weeks ]
    Episodes of Opportunistic infections - Clinical outcomes
  • Occurrence of re-feeding syndrome [ Time Frame: 12 weeks ]
    Episodes of Opportunistic infections - Clinical outcomes
  • Pharmacological: Cmax [ Time Frame: 12 weeks ]
    Cmax of Non-nucleotide reverse - transcriptase inhibitors (NNRTI) and Protease Inhibitors(PIs) at 0weeks, 6weeks,12weeks
  • Pharmacological: AUC [ Time Frame: 12 weeks ]
    Area Under Curve (AUC) Time Frame: 0weeks, 6weeks, 12weeks for nevirapine and lopinvir/retonavir
  • Number of participants with adverse events [ Time Frame: 12 weeks ]
    Pharmacological: Number of participants with adverse events


Original Secondary Outcome: Same as current

Information By: Makerere University

Dates:
Date Received: February 18, 2015
Date Started: February 2015
Date Completion: April 2016
Last Updated: April 15, 2015
Last Verified: April 2015