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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

F

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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