Status:
COMPLETED
Randomized Placebo-controlled Pilot Trial of Prebiotics+Glutamine in HIV Infection
Lead Sponsor:
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Conditions:
HIV
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
A rapid and almost complete loss of CD4+ T cells from the gut associated lymphoid tissue (GALT) occurs early in HIV infection, with a permanent damage in the intestinal barrier, changes in gut microbi...
Detailed Description
This is a randomized placebo-controlled clinical trial to evaluate the safety and effectiveness to modify gut microbiota, bacterial translocation, immune activation and markers of endothelial dysfunct...
Eligibility Criteria
Inclusion
- After receiving information on the design and objectives of the study, the possible risks involved, and the fact that they can refuse to collaborate at any time, patients will give their informed consent to participate in the study and agree to provide material for the cellular and molecular studies.
- Aged over 18 years.
- Group 1: HIV+, Not receiving ART and no previous exposure to ART, at least 2 years since HIV diagnosis.
- Group 2: HIV+, currently receiving ART for more than 2 years, HIV-1 RNA levels less than 40 copies/ml and more than 350 CD4+ T-cells/uL.
- Group 3: HIV+, currently receiving ART for more than 2 years, HIV-1 RNA levels less than 40 copies/ml and less than 350 CD4+ T-cells/uL.
- Group 4: HIV-, healthy controls.
Exclusion
- Major cardiovascular risk factors.
- Concomitant acute diseases.
- Gastrointestinal disorders.
- Pregnancy.
- Antibiotic exposure in the previous month.
- Regular use of foods or supplements containing prebiotics or probiotics within the 2 weeks prior to initiation of the study.
Key Trial Info
Start Date :
January 10 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2018
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01838915
Start Date
January 10 2017
End Date
June 1 2018
Last Update
February 11 2019
Active Locations (1)
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1
Hospital Ramón y Cajal and Hospital Clínico San Carlos
Madrid, Spain, 28034