Skip to main content
OpenTrials
Completed

NCT Number: NCT02640625

Improving Prognosis in HIV Infection

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

25 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Oslo University Hospital (Ullevaal campus)

Oslo, 0424, Norway

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic compound

Dietary Supplement

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

Primary outcomes

  1. Adverse Effects

    Time frame: 10 weeks

    Number of Participants who Experienced Adverse Effects

  2. Delta HIV Viral Load

    Time frame: 8 weeks

    Unit og Measure: copies/mL

  3. Delta Blood CD4 Count

    Time frame: 8 weeks

    Unit of Measure: cells/microL

Secondary outcomes

  1. Alteration in Gut Microbiota Composition

    Time frame: 8 weeks

    Explorative (Unit of Measure: Descriptive)

  2. Alterations in Epithelial Gene Expression

    Time frame: 8 weeks

    Explorative (Unit of Measure: Descriptive)

  3. Alterations in Lamina Propria T Cell Subsets

    Time frame: 8 weeks

    Explorative assays on T cell subsets distribution and function (Unit of Measure: Frequency)

  4. Alterations in Systemic T Cell Intracellular Signaling

    Time frame: 8 weeks

    Explorative assays on T cell receptor signaling mechanism (Unit of Measure: Frequency)

  5. 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)

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • University of Oslo

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 29, 2015
Registry last updated
Dec 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.