Evaluation of Aloe and Whey Protein on HIV Enteritis

Not Applicable

• Conditions: HIV/AIDS; Nutritional, Metabolic, Endocrine; Paediatrics

• Registration Number: PACTR201602001486700
• Lead Sponsor: Armauer Hansen Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-23
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

¿Enrolled at the ALERT Hospital Pediatric HIV Clinic for greater than 1 year or with complete records transferred from another Pediatric HIV Clinic.
¿Age between 4-8 years
¿History of cART for >6 months.
¿Able/willing to return to clinic weekly to collect supplement and complete weekly health history form.
¿Able/willing to participate in every 3 month extended clinic visits and blood draws
¿Able/willing to ingest study supplements

Exclusion Criteria

¿Any physical condition that precludes ingestion of food and study interventions
¿Suspected to have or with documented coinfection with TB disease
¿Any known cancers
¿Hx of hepatic or renal failure
¿Neurological/neuromuscular disease (cerebral palsy, muscular dystrophy, etc.)
¿Enrollment in another research study or project with medicinal or nutritional interventions
¿Children who have been on nutritional therapy (for severe wasting or PEM) in the last 6 months.
¿History of non-compliance with therapy
¿Another family or household member enrolled in same study
¿History of antihelminth treatment in last 3 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intestinal Fatty Acid Binding Protein levels

Secondary Outcome Measures

Name	Time	Method
Endotoxin;inflammatory Cytokines, IL-1B, IL-6, TNFa;Immune activation markers;Immune reconstitution indicators and markers of recent thymic emigrants;Total Oxidation Status;Total Glutathione