Netherlands Cohort Study on Acute HIV Infection
ConditionAcute HIV Infection
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorProf. Jan Prins
About this trial
Investigation of the size, variability and localization of the (pro) viral reservoir and the properties of HIV-specific immune response related to "post-treatment viral remission' achievement and / or duration. In addition we will study the factors that determine latency in the different host cells, their sensitivity to induction of replication competent virus by various agents and the potential application of these agents in "post-treatment viral remission".
This all will be studied in patients included during acute phase of the infection who start antiretroviral therapy immediately upon diagnosis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Written informed consent to store samples and perform genetic testing.
Separate written informed consent for invasive sampling procedures: leukapheresis, sigmoidoscopy with biopsies, lymph node excision biopsy and lumbar puncture, with storage of samples.
Age >= 18 years
An acute HIV-1 infection, defined according to the Fiebig stages I-IV (acute infection), 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 (recent infection) will only be included if they have a documented negative HIV test 6 months prior to the positive test or if they are in Fiebig stage V with a p31 negative blot
Disqualifiers
Contraindication for proposed cART regimen (e.g. impaired renal function).
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.
Trial population
The study population includes patients diagnosed with an AHI (Fiebig stage I-V, 20 in each stage). As a control group only for comparison of the lymph node viral reservoir and immune responses after 3 years of cART, 20 age-matched patients will be included who start cART in the chronic phase of infection. This control group is recruited to provide PBMCs and a LN sample for comparison purposes. Patients will be recruited over a period of 5 consecutive years.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
183 Participants
are grouped into 4 trial groupsGroup A: Group 1
Group B: Group 2A
Group C: Group 2B
Group D: Group 3
Trial outcomes
Primary outcomes
1
The establishment of a prospective cohort study of patients that initiate cART during the acute infection phase, aiming at achieving "post-treatment viral remission".
Time frame
10 yearsSecondary outcomes
1
Characterize the viro-immunological factors that correlate with achievement of "post-treatment viral remission" for several years in these patients.
Time frame
10 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Prof. Jan Prins
Lead sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor institution
UMC Utrecht
Collaborator
Rijnstate Hospital
Collaborator
Erasmus Medical Center
Collaborator
Onze Lieve Vrouwe Gasthuis
Collaborator
Radboud University Medical Center
Collaborator
Maasstad Hospital
Collaborator
DC Clinics
Collaborator
Amsterdam UMC, location VUmc
Collaborator
Leiden University Medical Center
Collaborator
Source ClinicalTrials.gov