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

U

University of Roma La Sapienza

Status

Unknown

Conditions

HIV Infection

Treatments

Drug: Tenofovir-Emtricitabine plus Lopinavir/Ritonavir or Darunavir/Ritonavir

Study type

Interventional

Funder types

Other

Identifiers

NCT02097381
DPHID-UniRoma01

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

naïve for cART that met the criteria to start treatment
Other group
Description:
patients naïve for antiretroviral treatment that met the criteria to start cART according to International Guidelines. These patients will be studied for primary and secondary outcomes after a short term antiretroviral therapy.
Treatment:
Drug: Tenofovir-Emtricitabine plus Lopinavir/Ritonavir or Darunavir/Ritonavir

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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