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Improving Prognosis in HIV Infection

Primary Purpose

Human Immunodeficiency Virus

Status
Completed
Phase
Phase 1
Locations
Norway
Study Type
Interventional
Intervention
Probiotic compound
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Human Immunodeficiency Virus focused on measuring HIV, Probiotics, Microbiota, Mucosal immunology, Gut biopsy

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)MaleAccepts 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

Sites / Locations

  • Oslo University Hospital (Ullevaal campus)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Probiotic compound

Arm Description

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

Outcomes

Primary Outcome Measures

Adverse Effects
Number of Participants who Experienced Adverse Effects
Delta HIV Viral Load
Unit og Measure: copies/mL
Delta Blood CD4 Count
Unit of Measure: cells/microL

Secondary Outcome Measures

Alteration in Gut Microbiota Composition
Explorative (Unit of Measure: Descriptive)
Alterations in Epithelial Gene Expression
Explorative (Unit of Measure: Descriptive)
Alterations in Lamina Propria T Cell Subsets
Explorative assays on T cell subsets distribution and function (Unit of Measure: Frequency)
Alterations in Systemic T Cell Intracellular Signaling
Explorative assays on T cell receptor signaling mechanism (Unit of Measure: Frequency)
Alterations in Systemic Markers of Immune Activation
Explorative assays on soluble inflammation markers and lymphoid cells activation status (Unit of Measure: Descriptive)

Full Information

First Posted
December 16, 2015
Last Updated
December 2, 2021
Sponsor
Oslo University Hospital
Collaborators
University of Oslo
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1. Study Identification

Unique Protocol Identification Number
NCT02640625
Brief Title
Improving Prognosis in HIV Infection
Official Title
Adjuvant Mucosal Therapy in HIV-infected Men With Insufficient Response to Antiretroviral Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
University of Oslo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus
Keywords
HIV, Probiotics, Microbiota, Mucosal immunology, Gut biopsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Probiotic compound
Arm Type
Experimental
Arm Description
Lactobacillus rhamnosus GG, Lactobacillus acidophilus, Lactobacillus bulgaricus, Bifidobacterium animalis subsp. lactis, and Streptococcus thermophilus.
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic compound
Intervention Description
Lactobacillus rhamnosus GG, Lactobacillus acidophilus, Lactobacillus bulgaricus, Bifidobacterium animalis subsp. lactis, and Streptococcus thermophilus.
Primary Outcome Measure Information:
Title
Adverse Effects
Description
Number of Participants who Experienced Adverse Effects
Time Frame
10 weeks
Title
Delta HIV Viral Load
Description
Unit og Measure: copies/mL
Time Frame
8 weeks
Title
Delta Blood CD4 Count
Description
Unit of Measure: cells/microL
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Alteration in Gut Microbiota Composition
Description
Explorative (Unit of Measure: Descriptive)
Time Frame
8 weeks
Title
Alterations in Epithelial Gene Expression
Description
Explorative (Unit of Measure: Descriptive)
Time Frame
8 weeks
Title
Alterations in Lamina Propria T Cell Subsets
Description
Explorative assays on T cell subsets distribution and function (Unit of Measure: Frequency)
Time Frame
8 weeks
Title
Alterations in Systemic T Cell Intracellular Signaling
Description
Explorative assays on T cell receptor signaling mechanism (Unit of Measure: Frequency)
Time Frame
8 weeks
Title
Alterations in Systemic Markers of Immune Activation
Description
Explorative assays on soluble inflammation markers and lymphoid cells activation status (Unit of Measure: Descriptive)
Time Frame
8 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dag Henrik Reikvam, MD PhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital (Ullevaal campus)
City
Oslo
ZIP/Postal Code
0424
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
34878437
Citation
Meyer-Myklestad MH, Medhus AW, Stiksrud B, Lorvik KB, Seljeflot I, Hansen SH, Holm K, Hov JR, Kvale D, Dyrhol-Riise AM, Kummen M, Troseid M, Reikvam DH. Probiotics to HIV-Infected Immunological Nonresponders: Altered Mucosal Immunity and Microbial Diversity Restricted to Ileum. J Acquir Immune Defic Syndr. 2022 Jan 1;89(1):77-86. doi: 10.1097/QAI.0000000000002817.
Results Reference
derived

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Improving Prognosis in HIV Infection

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