NCT05728996 Netherlands Cohort Study on Acute HIV Infection
| NCT ID | NCT05728996 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Prof. Jan Prins |
| Condition | Acute HIV Infection |
| Study Type | OBSERVATIONAL |
| Enrollment | 183 participants |
| Start Date | 2015-08-01 |
| Primary Completion | 2028-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 183 participants in total. It began in 2015-08-01 with a primary completion date of 2028-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05728996 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute HIV Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05728996 currently recruiting?
Yes, NCT05728996 is actively recruiting participants. Contact the research team at p.vanpaassen@amsterdamumc.nl for enrollment information.
Where is the NCT05728996 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands.
Who is sponsoring the NCT05728996 clinical trial?
NCT05728996 is sponsored by Prof. Jan Prins. The trial plans to enroll 183 participants.
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