etherlands Cohort Study on Acute HIV Infectio

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 240

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

-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.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- the cell associated viral reservoir size (total integrated HIV DNA, 2LTR<br /><br>circles, single copy RNA, cell associated RNA, viral outgrowth and inducible<br /><br>RNA) in peripheral blood, lymph node and GALT and viral load in CSF during the<br /><br>three to five years after initiation of cART.<br /><br>- the functional properties of the HIV-specific CD8+ T cell, B cell and T<br /><br>follicular helper cell response during the three years after initiation of cART.<br /><br>- immune activation parameters (type I interferons, IFN, IL-6, IL-10, IL-15,<br /><br>IL18, IL-22, sCD14, CRP, TGF, IL-1, IL8, sCD163, IP-10) during the three years<br /><br>after initiation of cART.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- the replication competent viral reservoir (as described in methods section,<br /><br>paragraph 8.3.2) in peripheral blood, lymph nodes, GALT and CSF during the<br /><br>three years after initiation of cART.</p><br>