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Prevalence of Cutaneous Autoimmune Phenomena in HIV Infected Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03129308
Recruitment Status : Completed
First Posted : April 26, 2017
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
Christopher Schuster, Medical University of Vienna

Tracking Information
First Submitted Date April 7, 2017
First Posted Date April 26, 2017
Last Update Posted Date August 20, 2019
Actual Study Start Date April 3, 2017
Actual Primary Completion Date May 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 21, 2017)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 21, 2017)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prevalence of Cutaneous Autoimmune Phenomena in HIV Infected Patients
Official Title A Controlled Cross Sectional Study: Prevalence of Cutaneous Autoimmune Phenomena in HIV Infected Patients
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.

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]
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration 1 Year
Biospecimen Retention:   Samples Without DNA
Description:
4.5ml of blood will be collected per patient and serum will be stored until final processing.
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

Condition
  • HIV Infections
  • Autoimmune Diseases Affecting Skin
Intervention 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
Study Groups/Cohorts
  • HIV infected patients
    4.5 ml of blood will be collected during a routine medical check-up.
    Intervention: Diagnostic Test: Blood Sampling
  • HIV negative control patients
    4.5 ml of blood will be collected during a routine medical check-up.
    Intervention: Diagnostic Test: Blood Sampling
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 18, 2019)
842
Original Estimated Enrollment
 (submitted: April 21, 2017)
900
Actual Study Completion Date September 15, 2018
Actual Primary Completion Date May 15, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • age ≥ 18 years
  • signed informed consent

Exclusion Criteria:

  • unwillingness to participate in the study
  • pregnancy
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Austria
Removed Location Countries  
 
Administrative Information
NCT Number NCT03129308
Other Study ID Numbers 1103/2017
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Christopher Schuster, Medical University of Vienna
Study Sponsor Medical University of Vienna
Collaborators Not Provided
Investigators
Principal Investigator: Christopher Schuster, AssocProf MD Department of Dermatology, Medical Univeristy of Vienna
PRS Account Medical University of Vienna
Verification Date August 2019