Human Immunodeficiency VirusPhase 1/2NCT02640625
Improving Prognosis in HIV Infection
A Phase 1/2 study testing Probiotic compound in people with Human Immunodeficiency Virus, run by Oslo University Hospital at 1 site in Norway.
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… Read more about this study
- Who is it for?
- Ages 25 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- Probiotic compound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2016to Apr 2017
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Human Immunodeficiency Virus
- Being tested
- Probiotic compound
- Keywords
- HIV, Probiotics, Microbiota, Mucosal immunology, Gut biopsy
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic compoundDietary supplement
Lactobacillus rhamnosus GG, Lactobacillus acidophilus, Lactobacillus bulgaricus, Bifidobacterium animalis subsp. lactis, and Streptococcus thermophilus.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic compound | Experimental | Lactobacillus rhamnosus GG, Lactobacillus acidophilus, Lactobacillus bulgaricus, Bifidobacterium animalis subsp. lactis, and Streptococcus thermophilus. Receives: Dietary Supplement: Probiotic compound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Effects
Number of Participants who Experienced Adverse Effects
Measured: 10 weeks
Delta HIV Viral Load
Unit og Measure: copies/mL
Measured: 8 weeks
Delta Blood CD4 Count
Unit of Measure: cells/microL
Measured: 8 weeks
Secondary outcomes (5)
Alteration in Gut Microbiota Composition
Explorative (Unit of Measure: Descriptive)
Measured: 8 weeks
Alterations in Epithelial Gene Expression
Explorative (Unit of Measure: Descriptive)
Measured: 8 weeks
Alterations in Lamina Propria T Cell Subsets
Explorative assays on T cell subsets distribution and function (Unit of Measure: Frequency)
Measured: 8 weeks
Alterations in Systemic T Cell Intracellular Signaling
Explorative assays on T cell receptor signaling mechanism (Unit of Measure: Frequency)
Measured: 8 weeks
Alterations in Systemic Markers of Immune Activation
Explorative assays on soluble inflammation markers and lymphoid cells activation status (Unit of Measure: Descriptive)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionMar 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Principal investigator, Dag Henrik Reikvam, Oslo University Hospital
- Investigators
- Dag Henrik Reikvam, MD PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02640625
- Sponsor's protocol ID
- REK 2015/2125
- Status last verified
- Dec 2021
- First submitted
- 16 Dec 2015
- Last updated
- 6 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 34878437
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Mucosal Therapy in HIV-infected Men With Insufficient Response to Antiretroviral Therapy
- ClinicalTrials.gov ID
- NCT02640625
- Acronym / sponsor ID
- REK 2015/2125
- Conditions
- Human Immunodeficiency Virus
- Keywords
- HIV, Probiotics, Microbiota, Mucosal immunology, Gut biopsy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- Jan 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 29 Dec 2015 (estimated)
- Results
- Posted 27 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Probiotic compound | Experimental | Dietary Supplement: Probiotic compoundLactobacillus rhamnosus GG, Lactobacillus acidophilus, Lactobacillus bulgaricus, Bifidobacterium animalis subsp. lactis, and Streptococcus thermophilus. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic compoundLactobacillus rhamnosus GG, Lactobacillus acidophilus, Lactobacillus bulgaricus, Bifidobacterium animalis subsp. lactis, and Streptococcus thermophilus. | Dietary supplement | Probiotic compound |
Primary outcome
Adverse Effects
Time frame: 10 weeks
Number of Participants who Experienced Adverse Effects
Delta HIV Viral Load
Time frame: 8 weeks
Unit og Measure: copies/mL
Delta Blood CD4 Count
Time frame: 8 weeks
Unit of Measure: cells/microL
5 secondary outcomes
Alteration in Gut Microbiota Composition
Time frame: 8 weeks
Alterations in Epithelial Gene Expression
Time frame: 8 weeks
Alterations in Lamina Propria T Cell Subsets
Time frame: 8 weeks
Alterations in Systemic T Cell Intracellular Signaling
Time frame: 8 weeks
Alterations in Systemic Markers of Immune Activation
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34878437Meyer-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dag Henrik Reikvam, MD PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Probiotic compound in people with Human Immunodeficiency Virus, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Effects (time frame: 10 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02640625, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2021.