Improving Prognosis in HIV Infection

Oslo University Hospital20 enrolled

Overview

The primary objective of this study is to assess the safety of probiotics in cART-treated immunologic non-responder (INR) patients with chronic HIV infection. The secondary objectives are to i) explore the biological effects of probiotics in combined antiretroviral therapy(cART)-treated INR patient with chronic HIV infection, and ii) investigate differences between cART-treated HIV-infected INR and non-INR patients with regards to gut microbial composition and mucosal barrier function.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Human Immunodeficiency Virus

Interventions

Probiotic compoundDIETARY_SUPPLEMENT

Lactobacillus rhamnosus GG, Lactobacillus acidophilus, Lactobacillus bulgaricus, Bifidobacterium animalis subsp. lactis, and Streptococcus thermophilus.

Eligibility

Sex: MALEMin age: 25 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * HIV seropositive \>4 years. * Continuous combined antiretroviral treatment (cART) \>4 years. * Plasma HIV RNA \<50 copies/mL \>3,5 years. * Cluster of differentiation(CD)4+ T cell count \<400 cells/µL (OR \>600 cells/µl) \>3.5 years. * Caucasian * Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to International Committee on Harmonization (ICH) Good Clinical Practice (GCP), and national/local regulations. Exclusion Criteria: * Plasma hepatitis C (HCV) RNA positive. * Serum hepatitis B surface antigen (HBsAg) positive. * Comorbidity of inflammatory bowel disease, coeliac disease or malnutrition. * Concomitant use of non-steroid anti-inflammatory drugs (NSAID), corticosteroids, disease-modifying antirheumatic drugs, or other anti-inflammatory pharmaceutical substances. * Concomitant use of antithrombotic pharmaceutical substances * Regular (weekly) use of any probiotic substance within 3 months prior to inclusion. * Use of antibiotics within 3 months prior to inclusion. * Deranged liver function (serum albumin \<25 g/L or Child-Pugh ≥10) * Renal failure (estimated glomerular filtration rate (eGFR) \<30 ml/min) * Heart failure (NYHA class II-IV) * Intolerance to milk or phenylalanine * Any reason why, in the opinion of the investigator, the patient should not participate

Locations (1)

Oslo University Hospital (Ullevaal campus)

Oslo, Norway

Outcomes

Primary Outcomes

Adverse Effects

Number of Participants who Experienced Adverse Effects

Time frame: 10 weeks

Delta HIV Viral Load

Unit og Measure: copies/mL

Time frame: 8 weeks

Delta Blood CD4 Count

Unit of Measure: cells/microL

Time frame: 8 weeks

Secondary Outcomes

Alteration in Gut Microbiota Composition

Explorative (Unit of Measure: Descriptive)

Time frame: 8 weeks

Alterations in Epithelial Gene Expression

Explorative (Unit of Measure: Descriptive)

Time frame: 8 weeks

Alterations in Lamina Propria T Cell Subsets

Explorative assays on T cell subsets distribution and function (Unit of Measure: Frequency)

Time frame: 8 weeks

Alterations in Systemic T Cell Intracellular Signaling

Explorative assays on T cell receptor signaling mechanism (Unit of Measure: Frequency)

Time frame: 8 weeks

Alterations in Systemic Markers of Immune Activation

Explorative assays on soluble inflammation markers and lymphoid cells activation status (Unit of Measure: Descriptive)

Time frame: 8 weeks

Data from ClinicalTrials.gov

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