Improving Prognosis in HIV Infection

University of Oslo (UIO)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Human Immunodeficiency Virus

Treatments: Dietary Supplement: Probiotic compound

Study type: Interventional

Funder types: Other

Identifiers

NCT02640625

REK 2015/2125

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: Male

Ages: 25 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Probiotic compound

Experimental group

Description:

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

Treatment:

Dietary Supplement: Probiotic compound