Netherlands Cohort Study on Acute HIV Infection

Launched by PROF. JAN PRINS · Feb 6, 2023

Keywords

ClinConnect Summary

This clinical trial, called the Netherlands Cohort Study on Acute HIV Infection, is looking at how the body responds to HIV during its early stages. Specifically, researchers want to understand where the virus hides in the body and how the immune system reacts to it. They’ll also explore ways to help people maintain a long-lasting control of the virus after treatment has finished. The study will involve patients who have just been diagnosed with acute HIV and will start treatment right away.

To participate, you need to be at least 18 years old and have an acute HIV infection as defined by specific testing criteria. You must also agree to give consent for various tests and procedures, such as blood sampling and biopsies. Participants can expect to undergo these tests and to receive antiretroviral therapy, which is a common treatment for HIV. It’s important to note that individuals with certain health issues or mental disorders that could affect treatment adherence may not be eligible. This study aims to improve our understanding of HIV management, especially during its early stages.

Gender

ALL

Eligibility criteria

• Inclusion 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 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 Criteria:
• • 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.