HIV Infection
Conditions
Keywords
HIV infection, HAART, Viral DNA test positive-10063306, Blood HIV RNA 10049826, Treatment Experienced
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.
Interventions
PROCEDUREGI 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)
BIOLOGICALA 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
Sponsors
ANRS, Emerging Infectious Diseases
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Correlation between HIV-1 viral load and CD4+ T lymphopenia in the GALT. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORMASSIP Patrice
University Hospital, Toulouse
Outcome results
None listed