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Prevalence of Cutaneous Autoimmune Phenomena in HIV Infected Patients

18. august 2019 opdateret af: Christopher Schuster, Medical University of Vienna

A Controlled Cross Sectional Study: Prevalence of Cutaneous Autoimmune Phenomena in HIV Infected Patients

The spectrum of reported autoimmune phenomena in HIV infected patients is unexpectedly broad and - owing to the current efficacious treatment regimes - increasing. The likelihood of the occurrence of autoimmune phenomena correlates with a high CD4 count, consequently they are found most frequently soon after infection or after immune reconstitution. It is likely that recent developments, namely the recommendation to treat all patients regardless of their CD4 count, may lead to a further increase in autoimmune phenomena in HIV infected patients. In contrast to the abundance of data of rheumatological and hematological autoimmune disease in HIV infected patients, no systematic study exists which has analyzed the prevalence of autoimmune blistering disease and/or associated autoantibodies in these patients.

The investigators therefore intend to determine the prevalence of selected autoantibodies in our HIV cohort in relation to uninfected controls. According to recent guidelines, all HIV infected patients should receive anti-retroviral treatment at the earliest time point possible, making the restoration of the immune system more likely and leading to a further alignment of the life expectancy relative to age matched, uninfected controls. As a consequence, the incidence of AIBD, especially of bullous pemphigoid, for which age is the single most important risk factor, may rise.

In total, knowledge about the prevalence of AIBD specific auto antibodies might be supportive in the diagnosis of these conditions in the future.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

So far no systematic studies exist about the prevalence and incidence of autoimmune blistering disease (AIBD) in HIV infected patients. Various case reports have been published, though the overall frequency appears to be low. The aim of this project is to investigate the frequency of various autoantibodies specific for various AIBD such as bullous pemphigoid, epidermolysis bullosa acquisita and paraneoplastic pemphigus using commercially available ELISA (BPAG1/2, desmoglein 1/3, collagen type VII, envoplakin) as well as indirect immunofluorescence. The knowledge of the frequency of these auto-antibodies in HIV infected patients may elucidate their clinical significance and also help in the diagnosis of AIBD in HIV infected patients.

In this cross sectional study all HIV infected patients at the HIV outpatient clinic (4-Süd) of the Department of Dermatology of Vienna's Medical University will be asked to participate in this study. Currently, the cohort includes approx. 1400 HIV infected patients and it is assumed that at least 600 patients will take part. In addition, it is intended to recruit 300 HIV negative patients who wish to get tested for HIV or require counselling for post-exposure prophylaxis. After receiving the informed consent, 4.5ml of blood will be collected during a routine medical check-up and the aforementioned tests performed.

The primary outcome is the prevalence of BPAG1/2 in HIV infected patients in comparison to uninfected, age matched controls. BPAG1/2 has been chosen as the primary end point given that bullous pemphigoid has the highest frequency among all AIBD. Secondary outcome measure will encompass the prevalence of auto antibodies against desmoglein1/3, collagen type VII, envoplakin as well as results from indirect immunofluorescence studies.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

842

Kontakter og lokationer

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Studiesteder

  • Østrig
      • Vienna, Østrig, 1090
        • Medical University of Vienna, Department of Dermatology

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

- all HIV infected patients (confirmed by ELISA, WB, and PCR) at the HIV outpatient clinic (4-Süd) of the Department of Dermatology of Vienna's Medical University

and

- all HIV negative patients at the HIV outpatient clinic (4-Süd) of the Department of Dermatology of Vienna's Medical University who wish to get tested for HIV or require counselling for post-exposure prophylaxis

Beskrivelse

Inclusion Criteria:

  • age ≥ 18 years
  • signed informed consent

Exclusion Criteria:

  • unwillingness to participate in the study
  • pregnancy

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Tværsnit

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
HIV infected patients
4.5 ml of blood will be collected during a routine medical check-up.
Diagnostisk test: Blood Sampling
4.5ml of blood will be collected and analyzed for the presence of cutaneous autoantibodies (indirect immunofluorescence, desmoglein1/3, BPAG1/2, collagenVII, and envoplakin ELISA)
Andre navne:
  • Blood Sampling in both groups
HIV negative control patients
4.5 ml of blood will be collected during a routine medical check-up.
Diagnostisk test: Blood Sampling
4.5ml of blood will be collected and analyzed for the presence of cutaneous autoantibodies (indirect immunofluorescence, desmoglein1/3, BPAG1/2, collagenVII, and envoplakin ELISA)
Andre navne:
  • Blood Sampling in both groups

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
prevalence of auto-antibodies against BPAG1/2
Tidsramme: up to 1 year
due to the highest frequency of bullous pemphigoid among all autoimmune blistering diseases the highest differences are expected for BPAG1/2
up to 1 year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
prevalence of auto-antibodies against other cutaneous antigens
Tidsramme: up to 1 year
prevalence of auto-antibodies against desmoglein1/3, collagenVII, envoplakin as well as results from indirect immunofluorescence studies
up to 1 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Medical University of Vienna

Efterforskere

  • Ledende efterforsker: Christopher Schuster, AssocProf MD, Department of Dermatology, Medical Univeristy of Vienna

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

3. april 2017

Primær færdiggørelse (Faktiske)

15. maj 2018

Studieafslutning (Faktiske)

15. september 2018

Datoer for studieregistrering

Først indsendt

7. april 2017

Først indsendt, der opfyldte QC-kriterier

21. april 2017

Først opslået (Faktiske)

26. april 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. august 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. august 2019

Sidst verificeret

1. august 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1103/2017

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med HIV-infektioner

Kliniske forsøg med Blood Sampling

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Betingelser

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Placeringer

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