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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

Sponsor
French National Agency for Research on AIDS and Viral Hepatitis (Other)
Overall Status
Completed
CT.gov ID
NCT01038401
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
19.9
Duration (Months)
1.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: GI endoscopy and GALT biopsies
  • Biological: A sample of venous blood will also be collected
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Sep 1, 2008
Actual Primary Completion Date :
May 1, 2010
Actual Study Completion Date :
May 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Other: HIV-1-infected patients on effective HAART

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
Other: Non Infected HIV Volunteers

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

  1. HIV-1 DNA load in the GALT vs blood CD4+ T cells []

  2. HIV-1 tropism in the GALT vs blood CD4+ T cells []

  3. Characterization of residual HIV-1 in the plasma < 40 copies/ml []

  4. Characterization of HIV-1 DNA in blood monocytes []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 ANRS center from Toulouse Toulouse France

Sponsors and Collaborators

  • French National Agency for Research on AIDS and Viral Hepatitis

Investigators

  • Principal Investigator: MASSIP Patrice, CHU Toulouse

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01038401
Other Study ID Numbers:
  • 2008-A00239-46
First Posted:
Dec 24, 2009
Last Update Posted:
Jul 14, 2010
Last Verified:
Jul 1, 2010
Keywords provided by , ,
HIV infection
HAART
Viral DNA test positive-10063306
Blood HIV RNA 10049826
Treatment Experienced
Additional relevant MeSH terms:
HIV Infections

Study Results

No Results Posted as of Jul 14, 2010