Overview

Study of Recovery of Intestinal CD4+ and Th17 T Cells in HIV-infected Individuals on Short-term Antiretroviral Therapy

Status:
Unknown status
Trial end date:
2014-12-01
Target enrollment:
0
Participant gender:
All
Summary
HIV infection is associated with a state of chronic, generalized immune activation that has been shown in many studies to be a key predictor of progression to AIDS. The molecular, cellular, and pathophysiological mechanisms underlying the HIV-associated immune activation are complex and still poorly studied. There is, however, growing consensus that both viral and host factors contribute to this phenotype, with emphasis on the role played by the mucosal immune dysfunction (and consequent microbial translocation). Moreover if it is known that in HIV-infected individuals, a severe depletion of intestinal cluster of differentiation 4 (CD4+) T-cells, is associated with loss of epithelium integrity, microbial translocation and systemic immune activation, the kinetics of intestinal CD4+ T-cell reconstitution under combined antiretroviral therapy (cART) remains poorly understood. This study sought to evaluate the reconstitution of intestinal CD4+ T-cells, including Th1 and Th17, in blood and colon samples collected from HIV-infected individuals before and after a short term cART.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Roma La Sapienza
Collaborator:
Istituto Superiore di Sanità
Treatments:
Darunavir
Emtricitabine
Lopinavir
Ritonavir
Tenofovir
Criteria
Inclusion Criteria:

- naïve for antiretroviral treatment

- met the criteria to start cART according to International Guidelines

- written informed consent signed

Exclusion Criteria:

- treatment with glucocorticosteroids and any immune modulating medication for more than
seven days in the previous month

- any past or current systemic malignancy, history of inflammatory diseases of the small
or large intestine

- pregnancy

- anemia, use of anticoagulants, and any contraindications to phlebotomy or colonoscopy.