Netherlands Cohort Study on Acute HIV Infection
Recruiting · NCT05728996 · Observational (researchers observe without assigning treatment) · Lead sponsor: Prof. Jan Prins
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
1 location listed.
- Amsterdam UMC, location AMC - Amsterdam, North Holland, Netherlands