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

HIV Infection Clinical Trial

— EP 44  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01038401
• Other study ID #: 2008-A00239-46
• Status: Completed
• Phase: N/A
• First received: December 22, 2009
• Last updated: July 13, 2010
• Start date: September 2008
• Est. completion date: May 2010

Study information

• Verified date: July 2010
• Source: French National Agency for Research on AIDS and Viral Hepatitis
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infection
• HIV Infections

Intervention

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

Locations

Country	Name	City	State
France	ANRS center from Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
French National Agency for Research on AIDS and Viral Hepatitis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between HIV-1 viral load and CD4+ T lymphopenia in the GALT.			No
Secondary	HIV-1 DNA load in the GALT vs blood CD4+ T cells			No
Secondary	HIV-1 tropism in the GALT vs blood CD4+ T cells			No
Secondary	Characterization of residual HIV-1 in the plasma < 40 copies/ml			No
Secondary	Characterization of HIV-1 DNA in blood monocytes			No

External Links

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