Residual Replication of HIV-1 in the Gut Associated Lymphoid Tissue (GALT) of Patients on Highly Active Antiretroviral Therapy (HAART): the ANRS EP 44 Study

This study has been completed.
Sponsor:
Information provided by:
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:
NCT01038401
First received: December 22, 2009
Last updated: July 13, 2010
Last verified: July 2010

December 22, 2009
July 13, 2010
September 2008
May 2010   (final data collection date for primary outcome measure)
Correlation between HIV-1 viral load and CD4+ T lymphopenia in the GALT. [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01038401 on ClinicalTrials.gov Archive Site
  • HIV-1 DNA load in the GALT vs blood CD4+ T cells [ Designated as safety issue: No ]
  • HIV-1 tropism in the GALT vs blood CD4+ T cells [ Designated as safety issue: No ]
  • Characterization of residual HIV-1 in the plasma < 40 copies/ml [ Designated as safety issue: No ]
  • Characterization of HIV-1 DNA in blood monocytes [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Residual Replication of HIV-1 in the Gut Associated Lymphoid Tissue (GALT) of Patients on Highly Active Antiretroviral Therapy (HAART): the ANRS EP 44 Study
Characterization of the Residual Replication of HIV-1 in the Gut-associated Lymphoid Tissue in Patients Receiving Effective Highly Active Antiretroviral Therapy: the ANRS EP 44 Study

HIV-1 cannot be eradicated from infected individuals by current antiretroviral regimens. Cellular reservoirs and tissue sanctuary sites allow latent HIV-1 persistence and ongoing low-level virus replication. This project aims to characterize the residual replication of HIV-1 in subjects on antiretroviral therapy, particularly in the gut-associated lymphoid tissue.

Highly active antiretroviral therapy (HAART) successfully controls HIV-1 replication in most individuals, resulting in substantial immune restoration and decreased morbidity and mortality. However HIV-1 cannot be eradicated from infected individuals by current regimens. Cellular reservoirs and tissue sanctuary sites allow latent HIV-1 persistence and ongoing low-level virus replication, despite maximum virus suppression on HAART. This project aims to characterize the residual replication of HIV-1 in subjects on HAART, particularly in the gut-associated lymphoid tissue (GALT). A group of 20 HIV-1-infected patients on effective HAART will undergo GI endoscopy and GALT biopsies will be taken. A sample of venous blood will also be collected. These samples will be use to characterize the residual viral populations on effective HAART in three compartments, plasma, monocytes, and GALT. HIV-1 coreceptor usage and its evolution on HAART will be characterized in virus reservoirs. This project could provide further insights into the residual replication of HIV-1 in subjects receiving HAART.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infection
  • Procedure: GI endoscopy and GALT biopsies
    This project aims to characterize the residual replication of HIV-1 in subjects on HAART, particularly in the gut-associated lymphoid tissue (GALT)
  • Biological: A sample of venous blood will also be collected
    These samples of blood will be use to characterize the residual viral populations on effective HAART in three compartments, plasma, monocytes, and GALT
  • HIV-1-infected patients on effective HAART
    Interventions:
    • Procedure: GI endoscopy and GALT biopsies
    • Biological: A sample of venous blood will also be collected
  • Non Infected HIV Volunteers
    Interventions:
    • Procedure: GI endoscopy and GALT biopsies
    • Biological: A sample of venous blood will also be collected
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
May 2010
May 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV-1 infection (ELISA and western-blot tests)
  • Continuous antiretroviral therapy >= 12 months
  • Plasma HIV-1 RNA =< 40 copies/ml >= 6 months
  • Indication of gastro-intestinal endoscopy
  • Age >= 18-year old
  • Physical examination
  • Informed consent

Exclusion Criteria:

  • Plasma HIV-1 RNA > 40 copies/ml in the last 6 months
  • Involvement in a HIV vaccine study
  • Treatment with interferon-alpha or PEG- interferon-alpha in the last 6 months
  • Treatment with interleukin-2 in the last 6 months
  • Decompensated cirrhosis
  • Abnormal hemostasis tests
  • Inflammatory bowel disease ; coeliac disease
  • Lymphoma
  • Blood transfusion in the last 6 months
  • Absence of social security (health insurance)
  • Pregnant or breastfeeding woman
  • Incapable adult
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01038401
2008-A00239-46
No
Lucie Marchand/Project manager, French National Agency for Research on AIDS and Viral Hepatitis
French National Agency for Research on AIDS and Viral Hepatitis
Not Provided
Principal Investigator: MASSIP Patrice CHU Toulouse
French National Agency for Research on AIDS and Viral Hepatitis
July 2010

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