NCT05728996Recruiting
Netherlands Cohort Study on Acute HIV Infection
Source: ClinicalTrials.gov · Last updated 15 Feb 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 183 (estimated)
- First submitted
- 6 Feb 2023
- Start date
- 1 Aug 2015
- Primary completion date
- 1 Aug 2028
- Lead sponsor
- Prof. Jan Prins
- Diseases
- HIV
- NCT number
- NCT05728996
What you commit to
- Study type: Observational
- Planned participants: 183
- From 1 Aug 2015 to the primary completion date, 1 Aug 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Contraindication for proposed cART regimen (e.g. impaired renal function).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amsterdam UMC, location AMC Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.