Improving Prognosis in HIV Infection

December 2, 2021 updated by: Dag Henrik Reikvam, Oslo University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0424
        • Oslo University Hospital (Ullevaal campus)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Probiotic compound
Lactobacillus rhamnosus GG, Lactobacillus acidophilus, Lactobacillus bulgaricus, Bifidobacterium animalis subsp. lactis, and Streptococcus thermophilus.
Dietary supplement: Probiotic compound
Lactobacillus rhamnosus GG, Lactobacillus acidophilus, Lactobacillus bulgaricus, Bifidobacterium animalis subsp. lactis, and Streptococcus thermophilus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Effects
Time Frame: 10 weeks
Number of Participants who Experienced Adverse Effects
10 weeks
Delta HIV Viral Load
Time Frame: 8 weeks
Unit og Measure: copies/mL
8 weeks
Delta Blood CD4 Count
Time Frame: 8 weeks
Unit of Measure: cells/microL
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alteration in Gut Microbiota Composition
Time Frame: 8 weeks
Explorative (Unit of Measure: Descriptive)
8 weeks
Alterations in Epithelial Gene Expression
Time Frame: 8 weeks
Explorative (Unit of Measure: Descriptive)
8 weeks
Alterations in Lamina Propria T Cell Subsets
Time Frame: 8 weeks
Explorative assays on T cell subsets distribution and function (Unit of Measure: Frequency)
8 weeks
Alterations in Systemic T Cell Intracellular Signaling
Time Frame: 8 weeks
Explorative assays on T cell receptor signaling mechanism (Unit of Measure: Frequency)
8 weeks
Alterations in Systemic Markers of Immune Activation
Time Frame: 8 weeks
Explorative assays on soluble inflammation markers and lymphoid cells activation status (Unit of Measure: Descriptive)
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

University of Oslo

Investigators

  • Principal Investigator: Dag Henrik Reikvam, MD PhD, Oslo University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

December 16, 2015

First Submitted That Met QC Criteria

December 22, 2015

First Posted (Estimate)

December 29, 2015

Study Record Updates

Last Update Posted (Actual)

December 6, 2021

Last Update Submitted That Met QC Criteria

December 2, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REK 2015/2125

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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