acute HIV infection, acute HIV infection acute HIV infection
Conditions
Interventions
There is no product or intervention
Sponsors
Academisch Medisch Centrum
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet the following criteria: -Written informed consent to store samples and perform genetic testing. -Separate written informed consent for invasive sampling procedures: leukapheresis, sigmoidoscopy with biopsies, lymph node biopsy or excision biopsy and lumbar puncture, to store samples and perform genetic testing. - Age >= 18 years - An acute HIV-1 infection, defined according to the modified Fiebig stages I-IV, as described in the previous paragraph (HIV-1 RNA positive and 4th generation ELISA negative or HIV-1 RNA positive and 4th generation HIV ELISA positive with indeterminate Western Blot). Patients in Fiebig stage V and VI will only be included if they have a documented negative HIV test 6 months prior to the (first) positive test. -Female subjects should be willing to use adequate contraception. Chronic control group: -Written informed consent to store samples and perform genetic testing -Separate written informed consent for sampling procedure: leukapheresis (or large blood draw), and/or lymph node excision biopsy, with storage of samples -Age >= 18 years -ART initiated in the chronic infection phase and chronic HIV-infection as confirmed by Western Blot (p31 positive) -Three to 5 years on ART with undetectable viral load and no more than two consecutive blips of >100 HIV RNA copies per mL of plasma in the year before enrollment Elite control group: -Written informed consent to store samples and perform genetic testing -Separate written informed consent for sampling procedure: leukapheresis (or large blood draw), and/or lymph node excision biopsy, with storage of samples -Age >= 18 years -Natural control of HIV infection, defined as having 3 undetectable HIV-1 RNA measurements >12 months upon diagnosis or 90% of HIV-1 RNA measurements undetectable >10 years.
Exclusion criteria
Exclusion criteria: -Contraindication for proposed cART regimen (e.g. impaired renal function) for participants enrolled with an acute HIV infection -Mental disorder that in the view of the investigator would interfere with adherence to the treatment or the study procedures, or the decision to participate in the study. -Immunosuppressive medication or other diseases associated with immunodeficiency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - the cell associated viral reservoir size (total integrated HIV DNA, 2LTR circles, single copy RNA, cell associated RNA, viral outgrowth and inducible RNA) in peripheral blood, lymph node and GALT and viral load in CSF during the three to five years after initiation of cART. - the functional properties of the HIV-specific CD8+ T cell, B cell and T follicular helper cell response during the three years after initiation of cART. - immune activation parameters (type I interferons, IFN*, IL-6, IL-10, IL-15, IL18, IL-22, sCD14, CRP, TGF*, IL-1, IL8, sCD163, IP-10) during the three years after initiation of cART. | — |
Secondary
| Measure | Time frame |
|---|---|
| - the replication competent viral reservoir (as described in methods section, paragraph 8.3.2) in peripheral blood, lymph nodes, GALT and CSF during the three years after initiation of cART. | — |
Countries
Netherlands
Contacts
Public ContactMJ Klouwens
Amsterdam UMC
Outcome results
None listed