Phase 2
N=20
Improving Prognosis in HIV Infection
Human Immunodeficiency Virus
Bottom Line
View on ClinicalTrials.gov: NCT02640625 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: Adverse Effects — 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Probiotic compound (Dietary_supplement)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- Male
- Sponsor
- Oslo University Hospital
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Effects |
1 | — |
| PRIMARY Delta HIV Viral Load |
— | — |
| PRIMARY Delta Blood CD4 Count |
18 | — |
| SECONDARY Alteration in Gut Microbiota Composition |
— | — |
| SECONDARY Alterations in Epithelial Gene Expression |
— | — |
| SECONDARY Alterations in Lamina Propria T Cell Subsets |
— | — |
| SECONDARY Alterations in Systemic T Cell Intracellular Signaling |
— | — |
| SECONDARY Alterations in Systemic Markers of Immune Activation |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- HIV seropositive >4 years.
- Continuous combined antiretroviral treatment (cART) >4 years.
- Plasma HIV RNA 3,5 years.
- Cluster of differentiation(CD)4+ T cell count 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
Data sourced from ClinicalTrials.gov (NCT02640625). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.