Improving Prognosis in HIV Infection

Human Immunodeficiency Virus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02640625
• Other study ID #: REK 2015/2125
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 2016
• Est. completion date: April 2017

Study information

• Verified date: December 2021
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus

Intervention

Dietary Supplement:
• Probiotic compound
Lactobacillus rhamnosus GG, Lactobacillus acidophilus, Lactobacillus bulgaricus, Bifidobacterium animalis subsp. lactis, and Streptococcus thermophilus.

Locations

Country	Name	City	State
Norway	Oslo University Hospital (Ullevaal campus)	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Effects	Number of Participants who Experienced Adverse Effects	10 weeks
Primary	Delta HIV Viral Load	Unit og Measure: copies/mL	8 weeks
Primary	Delta Blood CD4 Count	Unit of Measure: cells/microL	8 weeks
Secondary	Alteration in Gut Microbiota Composition	Explorative (Unit of Measure: Descriptive)	8 weeks
Secondary	Alterations in Epithelial Gene Expression	Explorative (Unit of Measure: Descriptive)	8 weeks
Secondary	Alterations in Lamina Propria T Cell Subsets	Explorative assays on T cell subsets distribution and function (Unit of Measure: Frequency)	8 weeks
Secondary	Alterations in Systemic T Cell Intracellular Signaling	Explorative assays on T cell receptor signaling mechanism (Unit of Measure: Frequency)	8 weeks
Secondary	Alterations in Systemic Markers of Immune Activation	Explorative assays on soluble inflammation markers and lymphoid cells activation status (Unit of Measure: Descriptive)	8 weeks