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

ANRS, Emerging Infectious Diseases30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HIV Infection

Interventions

GI endoscopy and GALT biopsiesPROCEDURE

This project aims to characterize the residual replication of HIV-1 in subjects on HAART, particularly in the gut-associated lymphoid tissue (GALT)

A sample of venous blood will also be collectedBIOLOGICAL

These samples of blood will be use to characterize the residual viral populations on effective HAART in three compartments, plasma, monocytes, and GALT

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

ANRS center from Toulouse

Toulouse, France

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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