Netherlands Cohort Study on Acute HIV Infection

NCT05728996 | Recruiting DMC

• 1 other identifier: NL51613.018.14
• Study Type: observational
• Target: 183
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute HIV Infection

Outcome Measures

Primary Outcomes (1)

• The establishment of a prospective cohort study of patients that initiate cART during the acute infection phase, aiming at achieving "post-treatment viral remission".

  10 years

Secondary Outcomes (1)

• Characterize the viro-immunological factors that correlate with achievement of "post-treatment viral remission" for several years in these patients.

  10 years

Study Arms (4)

Group 1

"standard": only routine diagnostic procedures are performed

Group 2A

"less invasive": in addition to routine monitoring, patients also undergo semen sampling

Group 2B

"less invasive": in addition to routine monitoring, patients undergo semen sampling and/or leukapheresis.

Group 3

"extended": patients undergo (in addition to routine sampling) semen sampling, invasive tissue sampling (GALT and/or lumbar puncture) and leukapheresis.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population includes patients diagnosed with an AHI (Fiebig stage I-V, 20 in each stage). As a control group only for comparison of the lymph node viral reservoir and immune responses after 3 years of cART, 20 age-matched patients will be included who start cART in the chronic phase of infection. This control group is recruited to provide PBMCs and a LN sample for comparison purposes. Patients will be recruited over a period of 5 consecutive years.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prof. Jan Prins: lead
• UMC Utrecht: collaborator
• Rijnstate Hospital: collaborator
• Erasmus Medical Center: collaborator
• Onze Lieve Vrouwe Gasthuis: collaborator
• Radboud University Medical Center: collaborator
• Maasstad Hospital: collaborator
• DC Clinics: collaborator
• Amsterdam UMC, location VUmc: collaborator
• Leiden University Medical Center: collaborator

Study Sites (1)

Amsterdam UMC, location AMC

Amsterdam, North Holland, 1105 AZ, Netherlands

RECRUITING

Related Publications (1)

• van Paassen P, Dijkstra M, Peay HL, Rokx C, Verbon A, Reiss P, Prins JM, Henderson GE, Rennie S, Nieuwkerk PT, de Bree GJ. Perceptions of Rapid Antiretroviral Therapy Initiation Among Participants of The Netherlands Cohort Study on Acute HIV Infection. AIDS Res Hum Retroviruses. 2024 May;40(5):286-292. doi: 10.1089/AID.2022.0169. Epub 2023 Oct 30.

  PMID: 37791419 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum PBMC Leukapheresis GALT Lymph node Cerebrospinal fluid

Central Study Contacts

Pien van Paassen, MD

CONTACT

0031642970500; p.vanpaassen@amsterdamumc.nl

Godelieve de Bree, MD PhD

CONTACT

g.j.debree@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Full professor

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: February 15, 2023
• Study Start: August 1, 2015
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: February 15, 2023

Record last verified: 2023-02

Locations

NL (1)