Prevalence of Cutaneous Autoimmune Phenomena in HIV Infected Patients

NCT03129308 | Completed

• 1 other identifier: 1103/2017
• Study Type: observational
• Target: 842
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections; Autoimmune Diseases Affecting Skin

Keywords

HIV; Cutaneous Autoantibodies; Indirect Immunofluorescence

Outcome Measures

Primary Outcomes (1)

• prevalence of auto-antibodies against BPAG1/2

  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

Secondary Outcomes (1)

• prevalence of auto-antibodies against other cutaneous antigens

  up to 1 year

Study Arms (2)

HIV infected patients

4.5 ml of blood will be collected during a routine medical check-up.

Diagnostic Test: Blood Sampling

HIV negative control patients

4.5 ml of blood will be collected during a routine medical check-up.

Diagnostic Test: Blood Sampling

Interventions

Blood Sampling DIAGNOSTIC_TEST

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)

Also known as: Blood Sampling in both groups

HIV infected patients; HIV negative control patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• age ≥ 18 years
• signed informed consent

You may not qualify if:

• unwillingness to participate in the study
• pregnancy

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna, Department of Dermatology

Vienna, 1090, Austria

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

4.5ml of blood will be collected per patient and serum will be stored until final processing.

MeSH Terms

Conditions

HIV Infections

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Christopher Schuster, AssocProf MD

  Department of Dermatology, Medical Univeristy of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Assoc. Prof.

Study Record Dates

• First Submitted: April 7, 2017
• First Posted: April 26, 2017
• Study Start: April 3, 2017
• Primary Completion: May 15, 2018
• Study Completion: September 15, 2018
• Last Updated: August 20, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)