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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Istituto Superiore di Sanità
Information provided by (Responsible Party):
Giancarlo Ceccarelli, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT02097381
First received: March 17, 2014
Last updated: March 26, 2014
Last verified: March 2014

March 17, 2014
March 26, 2014
April 2010
March 2014   (final data collection date for primary outcome 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) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
recovery of total Th1 and Th17 CD4+ T-cells (cell/mmc and %) in gut mucosa after 6 months of cARV)
Same as current
Complete list of historical versions of study NCT02097381 on ClinicalTrials.gov Archive Site
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) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
recovery of total Th1 and Th17 CD4+ T-cells (cell/mmc and %) in peripheral blood after 6 months of cARV)
Same as current
Not Provided
Not Provided
 
Study of Recovery of Intestinal CD4+ and Th17 T Cells in HIV-infected Individuals on Short-term Antiretroviral Therapy
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

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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
HIV Infection
Drug: Tenofovir-Emtricitabine plus Lopinavir/Ritonavir or Darunavir/Ritonavir

Conventional antiretroviral therapy started in naïve patients for antiretroviral treatment that met the criteria to start cART according to International Guidelines.

The antiretroviral treatment consisted in a tenofovir-emtricitabine NRTI backbone (TDF/FTC, 300/200 mg/ml, once a day) plus boosted protease inhibitor, lopinavir/ritonavir (LPV/r, 400/100 mg twice a day) or darunavir/ritonavir (DRV/r 800/100mg once a day).

Other Names:
  • Truvada
  • Prezista
  • Kaletra
  • Norvir
naïve for cART that met the criteria to start treatment

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.

Intervention: Drug: Tenofovir-Emtricitabine plus Lopinavir/Ritonavir or Darunavir/Ritonavir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
10
December 2014
March 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT02097381
DPHID-UniRoma01
Yes
Giancarlo Ceccarelli, University of Roma La Sapienza
University of Roma La Sapienza
Istituto Superiore di Sanità
Principal Investigator: Vincenzo Vullo, MD University of Roma La Sapienza
University of Roma La Sapienza
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP