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 (EP 44)
Primary Purpose
HIV Infection
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
GI endoscopy and GALT biopsies
A sample of venous blood will also be collected
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infection focused on measuring HIV infection, HAART, Viral DNA test positive-10063306, Blood HIV RNA 10049826, Treatment Experienced
Eligibility Criteria
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
Sites / Locations
- ANRS center from Toulouse
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
HIV-1-infected patients on effective HAART
Non Infected HIV Volunteers
Arm Description
Outcomes
Primary Outcome Measures
Correlation between HIV-1 viral load and CD4+ T lymphopenia in the GALT.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01038401
First Posted
December 22, 2009
Last Updated
July 13, 2010
Sponsor
French National Agency for Research on AIDS and Viral Hepatitis
1. Study Identification
Unique Protocol Identification Number
NCT01038401
Brief Title
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
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
French National Agency for Research on AIDS and Viral Hepatitis
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection
Keywords
HIV infection, HAART, Viral DNA test positive-10063306, Blood HIV RNA 10049826, Treatment Experienced
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HIV-1-infected patients on effective HAART
Arm Type
Other
Arm Title
Non Infected HIV Volunteers
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
GI endoscopy and GALT biopsies
Intervention Description
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
Biological
Intervention Name(s)
A sample of venous blood will also be collected
Intervention Description
These samples of blood will be use to characterize the residual viral populations on effective HAART in three compartments, plasma, monocytes, and GALT
Primary Outcome Measure Information:
Title
Correlation between HIV-1 viral load and CD4+ T lymphopenia in the GALT.
Secondary Outcome Measure Information:
Title
HIV-1 DNA load in the GALT vs blood CD4+ T cells
Title
HIV-1 tropism in the GALT vs blood CD4+ T cells
Title
Characterization of residual HIV-1 in the plasma < 40 copies/ml
Title
Characterization of HIV-1 DNA in blood monocytes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MASSIP Patrice
Organizational Affiliation
CHU Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
ANRS center from Toulouse
City
Toulouse
Country
France
12. IPD Sharing Statement
Links:
URL
http://anrs.fr
Description
Related Info
Learn more about this 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
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