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Taking people in NetherlandsNo phase

Studies HIV reservoir and immune response in people with recent HIV infection

Follows adults with acute HIV who start treatment right after diagnosis, studying the virus reservoir.

Plain-language title generated from the registry record
Registry title: Netherlands Cohort Study on Acute HIV Infection

Key facts

Where
Amsterdam, NetherlandsSee the site

Where in Netherlands

  • Amsterdam UMC, location AMCAmsterdam, NetherlandsTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Prof. Jan Prins
Trial code
NCT05728996
Record updated
15 February 2023
Original description
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".Read full original descriptionShow less

Netherlands Cohort Study on Acute HIV Infection

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.

Inclusion: 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; Female subjects should be willing to use adequate contraception.

Exclusion: 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; Contraindication for proposed cART regimen (e.g. impaired renal function).

ClinicalTrials.gov NCT05728996