Perceptions of Rapid Antiretroviral Therapy Initiation Among Participants of The Netherlands Cohort Study on Acute HIV Infection.
Pien van Paassen, Maartje Dijkstra, Holly L Peay...
https://pubmed.ncbi.nlm.nih.gov/37791419Actively Recruiting
Age: 18Years +
All Genders
ID05728996
Netherlands Cohort Study on Acute HIV Infection
Led by Prof. Jan Prins · Updated on 2023-02-15
183
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
P
Prof. Jan Prins
Lead Sponsor
U
UMC Utrecht
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the size, variability, and location of the viral reservoir in patients with acute HIV infection who start antiretroviral therapy immediately after diagnosis. The study aims to understand the immune responses related to achieving and maintaining "post-treatment viral remission," a state where the virus remains controlled without ongoing treatment. This prospective cohort study also explores factors that influence viral latency and tests agents that might help maintain remission. Patients diagnosed with acute HIV infection are offered immediate standard first-line combination antiretroviral therapy (cART). Participants are grouped based on their willingness to undergo additional sampling procedures: Group 1 receives routine diagnostic tests only; Group 2 adds semen sampling and leukapheresis; Group 3 includes invasive tissue and cerebrospinal fluid sampling alongside routine tests. A control group with chronic infection is included for comparison. Throughout the study, participants undergo regular sampling of blood, semen, lymph nodes, gut tissue, and cerebrospinal fluid to analyze viral reservoirs and immune function. These samples are collected at various times including baseline, 24 weeks, and three years. The research monitors how these factors correlate with post-treatment viral remission over several years. The study combines routine clinical care visits with research procedures to minimize participant burden, and the total study duration is up to 10 years.
CONDITIONS
Brief Title
Netherlands Cohort Study on Acute HIV Infection
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Written informed consent to store samples and perform genetic testing
- Separate written informed consent for invasive sampling procedures including leukapheresis, sigmoidoscopy with biopsies, lymph node excision biopsy, and lumbar puncture
- Age 18 years or older
- Diagnosed with acute HIV-1 infection according to Fiebig stages I-IV or specific criteria for stages V and VI
- Female participants must be willing to use adequate contraception
You will not qualify if you...
- Contraindication for the proposed antiretroviral treatment regimen, such as impaired renal function
- Mental disorder that may interfere with treatment adherence or study participation
- Use of immunosuppressive medication or presence of other diseases causing immunodeficiency
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - Up to 10 years
Participants diagnosed with acute HIV infection start combination anti-retroviral therapy (cART) and are monitored to analyze viral reservoir size and immune function. The extent of sampling varies by participant group, from routine diagnostic procedures to additional blood, semen, tissue, and cerebrospinal fluid sampling.
Routine clinical visits combined with additional sampling visits depending on group assignment
Trial Site Locations
Total: 1 location
1
Amsterdam UMC, location AMC
Amsterdam, North Holland, Netherlands, 1105 AZ
Actively Recruiting
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Research Team
P
Pien van Paassen, MD
G
Godelieve de Bree, MD PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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