Status:
COMPLETED
The Effect of Probiotics in HIV-1 Infection
Lead Sponsor:
Oslo University Hospital
Collaborating Sponsors:
Karolinska University Hospital
Tine
Conditions:
HIV-1 Infection
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
HIV progression is closely associated with chronic immune activation driven by leakage of bacterial products from a damaged gut, the investigators largest immunological organ. Notably, the degree of i...
Detailed Description
Objectives: To explore (i) the safety and tolerability, and (ii) the efficacy of probiotics on HIV-associated microbial translocation, systemic immune activation, disease progression and composition ...
Eligibility Criteria
Inclusion
- For patients without ART: Confirmed diagnosis of HIV infection \> 6 months and CD4+ T cell count \< 900
- For patients on stable, effective ART: HIV RNA \< 50 copies/ml \> 6 months and CD4+ T cell count \> 500
- Signed informed consent.
Exclusion
- Severe illness requiring hospitalization
- Systemic antibiotics or probiotics the last two months
- Current immune modulating therapy
- Infectious diarrhea
- Inflammatory bowel disease
- Acute primary HIV infection
- Patients immigrating from Africa, Asia or Latin-America within the last 6 months.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01439841
Start Date
October 1 2011
End Date
June 1 2013
Last Update
September 28 2017
Active Locations (2)
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1
Oslo University Hospital
Oslo, Norway, 0407
2
Karolinska University Hospital Huddinge
Stockholm, Sweden, 14186