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
  Purpose

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.


Condition Intervention
HIV Infection
Drug: Tenofovir-Emtricitabine plus Lopinavir/Ritonavir or Darunavir/Ritonavir

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

Resource links provided by NLM:


Further study details as provided by University of Roma La Sapienza:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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)


Enrollment: 10
Study Start Date: April 2010
Estimated Study Completion Date: December 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02097381

Locations
Italy
Department of Public Health and Infectious Diseases, University of Rome "Sapienza", Italy
Rome, RM, Italy, 00161
Sponsors and Collaborators
University of Roma La Sapienza
Istituto Superiore di Sanità
Investigators
Principal Investigator: Vincenzo Vullo, MD University of Roma La Sapienza
  More Information

No publications provided

Responsible Party: Giancarlo Ceccarelli, MD, PhD, MSc, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT02097381     History of Changes
Other Study ID Numbers: DPHID-UniRoma01
Study First Received: March 17, 2014
Last Updated: March 26, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by University of Roma La Sapienza:
HIV infection
GUT
microbial translocation
chronic inflammation
antiretroviral therapy
cART
HAART
Th17
Th1
CD4+

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Ritonavir
Lopinavir
Darunavir
Tenofovir
Emtricitabine
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 22, 2014