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

Not Applicable

• Conditions: HIV Infection
• Interventions: Drug: Tenofovir-Emtricitabine plus Lopinavir/Ritonavir or Darunavir/Ritonavir

• Registration Number: NCT02097381
• Lead Sponsor: University of Roma La Sapienza

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Status Verified: 2014-03
• Primary Completion: 2014-03
• Study First Submitted: 2014-03-17
• Study First Submitted QC: 2014-03-26
• Last Update Submitted: 2014-03-26
• Study First Posted: 2014-03-27
• Last Update Posted: 2014-03-27
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
naïve for cART that met the criteria to start treatment	Tenofovir-Emtricitabine plus Lopinavir/Ritonavir or Darunavir/Ritonavir	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.

Primary Outcome Measures

Name	Time	Method
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)	6 months	recovery of total Th1 and Th17 CD4+ T-cells (cell/mmc and %) in gut mucosa after 6 months of cARV)

Secondary Outcome Measures

Name	Time	Method
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)	6 months	recovery of total Th1 and Th17 CD4+ T-cells (cell/mmc and %) in peripheral blood after 6 months of cARV)

Trial Locations

Locations (1)

Department of Public Health and Infectious Diseases, University of Rome "Sapienza", Italy; 🇮🇹 Rome, RM, Italy