Status:
UNKNOWN
Mediterranean Diet and Bacterial Translocation and Immune-activation in Patients With HIV
Lead Sponsor:
Hospital Clinic of Barcelona
Conditions:
Hiv
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Evaluate if a change to a Mediterranean diet supplemented with nuts and olive oil decreases bacterial translocation and immune activation by a change in the microbiome in successfully treated HIV-1 in...
Detailed Description
Mediterranean diet supplemented by nuts and extra virgin olive oil has shown to reduce mortality, cardiovascular diseases, and breast cancer in HIV uninfected individuals. It is likely that changes in...
Eligibility Criteria
Inclusion
- Patient ≥ 18 years of age;
- To sign voluntary informed consent;
- Male or female patients with a negative pregnancy test before inclusion in the study;
- Proven HIV infection (with HIV-1 positive antibodies);
- Patient should be on stable treatment with cART for at least 1 year
- The mean of all CD4 measurements during the year prior to the initiation of cART should be equal to greater than 350 cells / mm3
- The number of CD4 + at the time of recruitment must be equal to or greater than 500 cells / mm3;
- HIV viral load should be undetectable at least 6 months prior to study inclusion, and less determinations (occasional blips above the undetectable level are allowed).
Exclusion
- Acquired Immunodeficiency Syndrome.
- Active opportunistic diseases.
- Patients coinfected with HCV or HBV
- Coagulopathy
- Renal insufficiency (creatinine\> 1.5 mg / dL)
- Pregnancy or breastfeeding
- Inability to sign informed consent
- Active opportunistic infections, or any active infection or cancer within 30 days prior to the screening visit;
- Therapy with immunomodulatory agents, including cytokines (eg IL-2) and gammaglobulins or chemotherapy within 90 days prior to the screening visit;
- Use of anticoagulant medication;
- Use of any type of experimental medication during the 90 days prior to study entry;
- Uncontrolled psychiatric disorder;
- Patients with uncontrolled active autoimmune diseases;
- Usual use of antibiotics
Key Trial Info
Start Date :
July 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT03846206
Start Date
July 1 2016
End Date
December 1 2019
Last Update
August 21 2019
Active Locations (1)
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1
Felipen Garcia
Barcelona, Spain, 08036