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

French National Agency for Research on AIDS and Viral Hepatitis

Status: Completed

Conditions: HIV Infection

Treatments: Procedure: GI endoscopy and GALT biopsies; Biological: A sample of venous blood will also be collected

Study type: Interventional

Funder types: Other

Identifiers

NCT01038401

2008-A00239-46

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

HIV-1-infected patients on effective HAART

Other group

Treatment:

Procedure: GI endoscopy and GALT biopsies

Biological: A sample of venous blood will also be collected

Non Infected HIV Volunteers

Other group

Treatment:

Procedure: GI endoscopy and GALT biopsies

Biological: A sample of venous blood will also be collected