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Phase 2 N=80 Randomized Double-blind Treatment

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

HIV Infections · Immunological Abnormality

Bottom Line

View on ClinicalTrials.gov: NCT03568812 ↗
Enrolled (actual)
80
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: CD4+ Level — 162.3; 50.5; 143.3; 69.9 cell/μL — p=0.02

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Rillus® (Drug); Placebo (Other)
Age
Adult · 18+ yrs
Sex
All
Sponsor
Indonesia University
Primary completion
Dec 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
CD4+ Level		 162.3; 50.5; 143.3; 69.9 0.02 sig
SECONDARY
Th17 Level Change		 -0.5; -0.2; -0.3; -0.4 0.55
SECONDARY
16S Ribosomal RNA (rRNA) Total		 NA; NA —
SECONDARY
Fecal Calprotectin Level Change		 -4.3; 8.4; -5.8; 9.9 0.03 sig
SECONDARY
Amount of Participants With HIV Related Symptoms		 -1.6; -1.3; -1.4; -1.11; -0.6; -0.1 —

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.

Eligibility 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03568812). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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