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

HIV Infection Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02097381
• Other study ID #: DPHID-UniRoma01
• Status: Active, not recruiting
• Phase: N/A
• First received: March 17, 2014
• Last updated: March 26, 2014
• Start date: April 2010
• Est. completion date: December 2014

Study information

• Verified date: March 2014
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: December 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infection
• HIV Infections
• Infection

Intervention

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).

Locations

Country	Name	City	State
Italy	Department of Public Health and Infectious Diseases, University of Rome "Sapienza", Italy	Rome	RM

Sponsors (2)

Lead Sponsor	Collaborator
University of Roma La Sapienza	Istituto Superiore di Sanità

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	recovery of total Th1 and Th17 CD4+ T-cells (cell/mmc and %) in gut mucosa after 6 months of cARV)	6 months	No
Secondary	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)	recovery of total Th1 and Th17 CD4+ T-cells (cell/mmc and %) in peripheral blood after 6 months of cARV)	6 months	No