Clinical trial NCT02097381: Study of Recovery of Intestinal CD4+ and Th17 T Cells in HIV-infected Individuals on Short-term Antiretroviral Therapy
Official title: HIV Infection and Gut Mucosal Immune Function: Longitudinal Analyses of Intestinal CD4+ and Th17 T Cells in HIV-infected Individuals on Short-term Antiretroviral Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV Infection
Keywords: HIV infection
GUT
microbial translocation
chronic inflammation
antiretroviral therapy
cART
HAART
Th17
Th1
CD4+
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
Collaborators: name: Istituto Superiore di Sanità
First posted: 2014-03-27
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Difference of number of total Th1 and Th17 CD4+ T-cells (cell/mmc and %) in colon samples between T0 (before start of cARV) and T1 (after 6 months of cARV)
timeFrame: 6 months
Secondary outcomes:
measure: Difference of number of total Th1 and Th17 CD4+ T-cells (cell/mmc and %) in blood samples between T0 (before start of cARV) and T1 (after 6 months of cARV)
timeFrame: 6 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Department of Public Health and Infectious Diseases, University of Rome "Sapienza", Italy
state: RM
Study officials:
affiliation: University of Roma La Sapienza
name: Vincenzo Vullo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: d'Ettorre G, Baroncelli S, Micci L, Ceccarelli G, Andreotti M, Sharma P, Fanello G, Fiocca F, Cavallari EN, Giustini N, Mallano A, Galluzzo CM, Vella S, Mastroianni CM, Silvestri G, Paiardini M, Vullo V. Reconstitution of intestinal CD4 and Th17 T cells in antiretroviral therapy suppressed HIV-infected subjects: implication for residual immune activation from the results of a clinical trial. PLoS One. 2014 Oct 23;9(10):e109791. doi: 10.1371/journal.pone.0109791. eCollection 2014.