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Prevalence of Cutaneous Autoimmune Phenomena in HIV Infected Patients

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ClinicalTrials.gov Identifier: NCT03129308
Recruitment Status : Recruiting
First Posted : April 26, 2017
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Christopher Schuster, Medical University of Vienna

Brief Summary:

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.


Condition or disease Intervention/treatment
HIV Infections Autoimmune Diseases Affecting Skin Diagnostic Test: Blood Sampling

Detailed Description:

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.


Study Type : Observational [Patient Registry]
Estimated Enrollment : 900 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Year
Official Title: A Controlled Cross Sectional Study: Prevalence of Cutaneous Autoimmune Phenomena in HIV Infected Patients
Actual Study Start Date : April 3, 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
HIV infected patients
4.5 ml of blood will be collected during a routine medical check-up.
Diagnostic 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)
Other Name: Blood Sampling in both groups
HIV negative control patients
4.5 ml of blood will be collected during a routine medical check-up.
Diagnostic 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)
Other Name: Blood Sampling in both groups



Primary Outcome Measures :
  1. prevalence of auto-antibodies against BPAG1/2 [ Time Frame: 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


Secondary Outcome Measures :
  1. prevalence of auto-antibodies against other cutaneous antigens [ Time Frame: up to 1 year ]
    prevalence of auto-antibodies against desmoglein1/3, collagenVII, envoplakin as well as results from indirect immunofluorescence studies


Biospecimen Retention:   Samples Without DNA
4.5ml of blood will be collected per patient and serum will be stored until final processing.


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

- 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

Criteria

Inclusion Criteria:

  • age ≥ 18 years
  • signed informed consent

Exclusion Criteria:

  • unwillingness to participate in the study
  • pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03129308


Contacts
Contact: Christopher Schuster, AssocProf MD +4314040400 ext 42400 christopher.schuster@meduniwien.ac.at
Contact: Veronique Touzeau, M.D. +4314040400 ext 42370 veronique.touzeau-roemer@meduniwien.ac.at

Locations
Austria
Medical University of Vienna, Department of Dermatology Recruiting
Vienna, Austria, 1090
Contact: Christopher Schuster, AssocProf MD    +43140400 ext 42400    christopher.schuster@meduniwien.ac.at   
Contact: Veronique Touzeau, M.D.    +43140400 ext 42370    veronique.touzeau-roemer@meduniwien.ac.at   
Principal Investigator: Christopher Schuster, AssocProf MD         
Sub-Investigator: Veronique Touzeau, M.D.         
Sub-Investigator: Armin Rieger, AssocProf MD         
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Christopher Schuster, AssocProf MD Department of Dermatology, Medical Univeristy of Vienna

Responsible Party: Christopher Schuster, M.D., Assoc. Prof., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT03129308     History of Changes
Other Study ID Numbers: 1103/2017
First Posted: April 26, 2017    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Christopher Schuster, Medical University of Vienna:
HIV
Cutaneous Autoantibodies
Indirect Immunofluorescence

Additional relevant MeSH terms:
HIV Infections
Autoimmune Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Autoantibodies
Immunologic Factors
Physiological Effects of Drugs