Netherlands Cohort Study on Acute HIV Infection

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
View:

• 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.

Locations
Other Locations
Netherlands
Amsterdam UMC, location AMC
RECRUITING
Amsterdam
Contact Information
Primary
Pien van Paassen, MD
p.vanpaassen@amsterdamumc.nl
0031642970500
Backup
Godelieve de Bree, MD PhD
g.j.debree@amsterdamumc.nl
Time Frame
Start Date: 2015-08-01
Estimated Completion Date: 2028-08-01
Participants
Target number of participants: 183
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: UMC Utrecht, Amsterdam UMC, location VUmc, Maasstad Hospital, DC Clinics, Radboud University Medical Center, Onze Lieve Vrouwe Gasthuis, Erasmus Medical Center, Rijnstate Hospital, Leiden University Medical Center
Leads: Prof. Jan Prins

This content was sourced from clinicaltrials.gov