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| Name | Class |
|---|---|
| ViiV Healthcare | INDUSTRY |
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In this prospective longitudinal study we aim to assess how immunologic and viral aspects of the human immunodeficiency virus (HIV) viral reservoir, established during early HIV infection and responsible for viral rebound at treatment interruption, evolve in individuals who start combination anti-retroviral therapy (cART) during acute seroconversion.
Recently infected patients will be selected based on Fiebig staging for an in depth sampling protocol at different timepoints during a 2 year follow up period. Colonbiopsies, lymphnode resection, lumbar puncture, leucapheresis and repeated peripheral venous blood-draws will be performed. Immunological, virological and genome expression analysis will be performed on the gathered samples.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early combination anti-retroviral treatment | Drug | Patients are started on treatment to supress the HIV virus in the phase of acute seroconversion. |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of virological and immunological parameters of the HIV reservoir in recently infected HIV positive patients that started treatment during acute seroconversion. | Virological, immunological and gene expression analysis on blood and tissue from in depth sampling. | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of microbiome in recently infected HIV positive patients that started treatment during acute seroconversion. | Microbiome analysis on stoolsamples. | 10 years |
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Inclusion Criteria:
Exclusion Criteria:
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We will enroll a minimum of 30 patients and a maximum of 70 participants (Fiebig stages I - VI) in the study to establish a cohort of early treated patients. We aim at including at least 15 people with an incomplete Western Blot (Fiebig I->IV) and as a control we will also include patients with complete Western Blot and history of a semi-recent infection (Fiebig V-VI).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Linos Vandekerckhove, Prof. Dr. | Contact | +3293323398 | linos.vandekerckhove@ugent.be |
| Name | Affiliation | Role |
|---|---|---|
| Linos Vandekerckhove, Prof. Dr. | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Gent | Recruiting | Ghent | Oost-Vlaanderen | 9000 | Belgium |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 31, 2018 | Feb 22, 2018 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 14, 2017 | Feb 22, 2018 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006679 | HIV Seropositivity |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |