HIV -1 Infection Clinical Trial
Official title:
Treatment With Probiotics (Saccharomyces Boulardii) and Its Role in Bacterial Translocation and Immune Reconstitution in VIH Infection.
Objectives: MAIN: To evaluate the parameters of microbial translocation after treatment with
probiotics (Saccharomyces boulardii) in HIV+ patients and its role on immune reconstitution
and the changes in gut microbiota composition.
SECONDARY OBJECTIVES: 1) To analyze the progress of immune activity markers after the
administration of probiotics. 2) To determine the improvement of CD4+ lymphocytes and HIV
viral load in patients after taking probiotics.
Methods: Design: A prospective randomized open controlled double-blinded trial, to be
performed at a tertiary care hospital in Barcelona. Subjects: Chronic HIV infected patients.
Sample size: 44 cases. They´ll be divided in 2 groups: (1) Patients with CD4 +> 400 cells /
ml and undetectable viral load for more than two years (22 cases) and (2) Patients with
immunodiscordancy, defined as patients with CD4 + T cells lower than 350 cells / ml despite
4-7 years of effective antiretroviral therapy. (22 cases). Intervention: Patients were
randomized in 2 subgroups: (A) they´ll receive daily oral supplementation with S. boulardii
for 3 months and (B) they ´ll receive placebo. Variables: bacterial lipopolisaccharide
levels measured by the Lipid-Binding protein (LBP), parameters of immune activation in
plasma (soluble CD14, IFN-Υ, TNF-Alpha, IL (interleukine)-2, IL-5, IL-6, IL-12)and gut
microbiota composition prior to the use of probiotics (baseline), at 3 and 6 months.
Immunological and clinical data. Outcome measures: quantification of bacterial translocation
levels, markers of activity and immune recovery. Analysis: Comparison of variables before
and after the intervention. The analysis will be performed by biological and immunological
effectiveness.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00642707 -
Study of PRO 140 by Subcutaneous Administration in Adult Subjects With HIV -1 Infection
|
Phase 2 |