Improving Prognosis in HIV Infection

Adjuvant Mucosal Therapy in HIV-infected Men With Insufficient Response to Antiretroviral Therapy

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.

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