The Role of Probiotics in HIV Patients With Immunological Non-Responder

• Status: Completed
• Trial end date: 2018-12-27
• Target enrollment: 0
• Participant gender: All

Summary

This study will address HIV patients who are on antiretroviral treatment (ART) and experiencing immunological failure. The cause of immunological failure in HIV patients could be due to several factors such as age, gender, Cluster of Differentiation (CD4)+ count before started treatment and some inflammation in the gut. The C-C Chemokine Receptor 5 (CCR5) receptor on T lymphocyte CD4+ are abundantly found in the gut and attacked by HIV virus during acute infection causing irreversible damage.

The disruption of gut integrity and chronic inflammation further causing translocation of bacteria in gut lumen to the blood. Thus resulting persistent low CD4+ or immunological failure.

This evaluation plan is designed to establish the role of investigation product (probiotics) to improve gut inflammation in HIV patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Indonesia University

Criteria

Inclusion Criteria:

• HIV patient with immunological non-responder status which defined as:

• first line antiretroviral therapy (ART) treated for minimal 6 months

• CD4+ level between 200-410 cell/μL

• HIV viral load <34 copies/mL

• giving consent to participate the study

Exclusion Criteria:

• being pregnant

• lactating

• known Lactobacillus allergy

• BMI <16 kg/m2

• under Tuberculosis treatment or other acute illness

• acute diarrhea

• routinely taking selenium containing vitamin in last 1 month

• routinely consuming probiotics containing product in last 1 month