Improving Prognosis in HIV Infection

NCT02640625 | Completed Phase 1 Results

• 1 other identifier: REK 2015/2125
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Immunodeficiency Virus

Keywords

HIV; Probiotics; Microbiota; Mucosal immunology; Gut biopsy

Outcome Measures

Primary Outcomes (3)

• Adverse Effects

  Number of Participants who Experienced Adverse Effects

  10 weeks

• Delta HIV Viral Load

  Unit og Measure: copies/mL

  8 weeks

• Delta Blood CD4 Count

  Unit of Measure: cells/microL

  8 weeks

Secondary Outcomes (5)

• Alteration in Gut Microbiota Composition

  8 weeks

• Alterations in Epithelial Gene Expression

  8 weeks

• Alterations in Lamina Propria T Cell Subsets

  8 weeks

• Alterations in Systemic T Cell Intracellular Signaling

  8 weeks

• Alterations in Systemic Markers of Immune Activation

  8 weeks

Study Arms (1)

Probiotic compound

EXPERIMENTAL

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

Dietary Supplement: Probiotic compound

Interventions

Probiotic compound DIETARY_SUPPLEMENT

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

Probiotic compound

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Oslo University Hospital: lead
• University of Oslo: collaborator

Study Sites (1)

Oslo University Hospital (Ullevaal campus)

Oslo, 0424, Norway

Location

Related Publications (1)

• 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.

  PMID: 34878437 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Dr. Dag Henrik Reikvam
• Organization: Oslo University Hospital

dagrei@ous-hf.no

+4722119881

Study Officials

• Dag Henrik Reikvam, MD PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: December 16, 2015
• First Posted: December 29, 2015
• Study Start: January 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: April 1, 2017
• Last Updated: December 6, 2021
• Results First Posted: March 27, 2020

Record last verified: 2021-12

Locations

NO (1)