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

NCT ID: NCT02097381

Last Updated: 2014-03-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2014-12-31

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.

Conditions

HIV Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Tenofovir-Emtricitabine plus Lopinavir/Ritonavir or Darunavir/Ritonavir

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: DRUG

Other Intervention Names

Truvada; Prezista; Kaletra; Norvir

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Superiore di Sanità

OTHER

Sponsor Role: collaborator

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Giancarlo Ceccarelli

MD, PhD, MSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vincenzo Vullo, MD

Role: PRINCIPAL_INVESTIGATOR

University of Roma La Sapienza

Locations

Department of Public Health and Infectious Diseases, University of Rome "Sapienza", Italy

Rome, RM, Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 25340778 (View on PubMed)

Other Identifiers

DPHID-UniRoma01

Identifier Type: -

Identifier Source: org_study_id