Cohort study on acute HIV infection and treatment outcomes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• Amsterdam UMC, location AMC
  Amsterdam, North Holland, Netherlands Recruiting

Study contacts

• Study coordinator: Pien van Paassen, MD
• Email: p.vanpaassen@amsterdamumc.nl
• Phone: 0031642970500

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Combining immune-enhancing antibodies and vaccines to control HIV after early infection

  This test will see if giving long-acting HIV antibodies together with therapeutic vaccines helps people who began ART during acute HIV infection control viral levels after a planned treatment interruption.

  Recruiting Phase 1 Henry M. Jackson Foundation for the Advancement of Military Medicine · Pathum Wan, Bangkok · NCT06484335

• Combination broadly neutralizing HIV antibodies given with ART during acute infection to try to induce remission

  This trial will try giving two HIV-specific broadly neutralizing antibodies along with starting ART to ART-naïve adults with acute HIV infection to see if it delays viral rebound and reduces the viral reservoir.

  Recruiting at 11 sites Phase 2 National Institute of Allergy and Infectious Diseases (NIAID) · Birmingham, Alabama and 11 other locations · NCT05719441

• Comparing standard and intensive HIV treatment for early infection

  This study is testing whether a standard HIV treatment or a stronger version works better for people who have just been diagnosed with HIV.

  Recruiting Phase 3 SEARCH Research Foundation · Bangkok · NCT00796263

• Characterizing acute HIV infection in high-risk individuals

  This study is trying to learn more about people with early HIV infection by looking at their health, behavior, and immune responses to help improve future treatments and vaccines.

  Recruiting SEARCH Research Foundation · Bangkok, Bangkok · NCT00796146

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.