Clinical Trial: 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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: French National Agency for Research on AIDS and Viral Hepatitis

Current Primary Outcome: Correlation between HIV-1 viral load and CD4+ T lymphopenia in the GALT.

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • HIV-1 DNA load in the GALT vs blood CD4+ T cells
  • HIV-1 tropism in the GALT vs blood CD4+ T cells
  • Characterization of residual HIV-1 in the plasma < 40 copies/ml
  • Characterization of HIV-1 DNA in blood monocytes


Original Secondary Outcome: Same as current

Information By: French National Agency for Research on AIDS and Viral Hepatitis

Dates:
Date Received: December 22, 2009
Date Started: September 2008
Date Completion:
Last Updated: July 13, 2010
Last Verified: July 2010