Improving Prognosis in HIV Infection
- Conditions
- Human Immunodeficiency Virus
- Interventions
- Dietary Supplement: Probiotic compound
- Registration Number
- NCT02640625
- Lead Sponsor
- Oslo University Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 20
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Probiotic compound Probiotic compound Lactobacillus rhamnosus GG, Lactobacillus acidophilus, Lactobacillus bulgaricus, Bifidobacterium animalis subsp. lactis, and Streptococcus thermophilus.
- Primary Outcome Measures
Name Time Method Adverse Effects 10 weeks Number of Participants who Experienced Adverse Effects
Delta HIV Viral Load 8 weeks Unit og Measure: copies/mL
Delta Blood CD4 Count 8 weeks Unit of Measure: cells/microL
- Secondary Outcome Measures
Name Time Method Alterations in Epithelial Gene Expression 8 weeks Explorative (Unit of Measure: Descriptive)
Alterations in Lamina Propria T Cell Subsets 8 weeks Explorative assays on T cell subsets distribution and function (Unit of Measure: Frequency)
Alterations in Systemic T Cell Intracellular Signaling 8 weeks Explorative assays on T cell receptor signaling mechanism (Unit of Measure: Frequency)
Alterations in Systemic Markers of Immune Activation 8 weeks Explorative assays on soluble inflammation markers and lymphoid cells activation status (Unit of Measure: Descriptive)
Alteration in Gut Microbiota Composition 8 weeks Explorative (Unit of Measure: Descriptive)
Trial Locations
- Locations (1)
Oslo University Hospital (Ullevaal campus)
🇳🇴Oslo, Norway