Cohort study on acute HIV infection and treatment outcomes
Netherlands Cohort Study on Acute HIV Infection
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · NCT05728996
This study is testing how starting HIV treatment right after diagnosis affects the chances of long-term remission in patients and what factors might help achieve that.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 183 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (other) |
| Drugs / interventions | cART |
| Locations | 1 site (Amsterdam, North Holland) |
| Trial ID | NCT05728996 on ClinicalTrials.gov |
What this trial studies
This study investigates the size and characteristics of the viral reservoir in patients with acute HIV infection who begin antiretroviral therapy immediately after diagnosis. It aims to understand the immune responses associated with achieving long-term viral remission after treatment interruption. By analyzing various factors that influence latency and the potential for using latency-reversing agents, the study seeks to identify key determinants of successful treatment outcomes. Patients will be monitored over time to assess viro-immunological factors related to their remission status.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with acute HIV-1 infection at specific Fiebig stages.
Not a fit: Patients with contraindications to the proposed antiretroviral therapy or those with severe mental disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for achieving long-term remission in HIV patients, potentially reducing the need for lifelong treatment.
How similar studies have performed: Previous studies have shown promise in achieving post-treatment viral remission in select individuals, indicating that this approach may be viable.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Amsterdam, North Holland
- Amsterdam UMC, location AMC — Amsterdam, North Holland, Netherlands (RECRUITING)
Study contacts
- Study coordinator: Pien van Paassen, MD
- Email: p.vanpaassen@amsterdamumc.nl
- Phone: 0031642970500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute HIV Infection