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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2010-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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HIV Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HIV-1-infected patients on effective HAART

Group Type OTHER

GI endoscopy and GALT biopsies

Intervention Type PROCEDURE

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 collected

Intervention Type BIOLOGICAL

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

Non Infected HIV Volunteers

Group Type OTHER

GI endoscopy and GALT biopsies

Intervention Type PROCEDURE

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 collected

Intervention Type BIOLOGICAL

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

Interventions

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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)

Intervention Type PROCEDURE

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes