Helicobacter pylori infection Infections and Infestations Helicobacter pylori infection in people with HIV infection
Conditions
Interventions
Patients included are divided into three groups:
1. Cases were HIV-positive individuals enrolled from 01/01/2006 to 31/08/2017
they receive standard of care
2. Controls were HIV-negative individuals enrolled from 01/01/2007 till 31/12/2014
they receive standard of care
3. Consecutive HIV-positive individuals recruited prospectively from 10/10/2017 to 10/09/2019
they receive HP treatment based on microbiology test only, a writing support material and phone call during the treatment course
The study will run from inclusion until approximately
Sponsors
Centre Hospitalier Universitaire de Saint-Pierre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age equal or more than 18 years 2. H. pylori infection proven either by culture with antimicrobial susceptibility test or by pathology examination of gastric samples obtained through upper gastrointestinal endoscopy 3. No prior history of HP treatment
Exclusion criteria
Exclusion criteria: 1. Pregnancy 2. Partial or total gastrectomy 3. Disagreement to participate 4. Prior history of HP treatment 5. History of anti-HP antibiotic allergy 6. End-stage organ dysfunction (liver disease or kidney disease with dialysis)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Among of HIV-co-infected individuals: Rate of first-line HP treatment failure (defined by a positive urea breath test performed at least 6 weeks after the treatment completion and 3 weeks after withdrawal of proton pump inhibitors) | — |
Secondary
| Measure | Time frame |
|---|---|
| Information collected from the patient during the study: 1. Types of first-line HP treatment 2. Demographics and clinical parameters 3. Immune function Exploratory outcome measures: 1. Type, duration, year of HP treatment will be collected and recorded at the beginning of the treatment using Excel file 2. Demographics: age measured in years, gender and ethnicity, based on the patient’s self-identification and geographic area of origin, and if necessary using hospital administrative database, body mass index measured in kg/m2, alcohol and tobacco habits measured using binary response. Co-medication evaluated by anamnesis, medical file and data provided by the family doctor. Those parameters will be collected at the time of HP infection treatment initiation. Adverse effects, tolerability will be collected “on” treatment using adapted questionnaire from de Boer W.A et al (1996): type and severity and ability to interfere with daily activity and treatment continuation. Compliance will be assessed by counting the pills returned by the patients after ending therapy 3. Immune function notably lymphocyte T CD4 count (measured using flow cytometry, NAVIOS) and HIV viral load (measured using COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test, v2.0 real time PCR), and HIV treatment data (composition, duration) will be collected at or close to the time of HP infection treatment initiation 4. Outcome: will be evaluated mainly by urea breath (using mass spectometry), eventually by microbiology and pathology examination of gastric samples, each performed at least 6 weeks after the withdrawal of antibiotics and 3 weeks after withdrawal of proton pump inhibitors | — |
Countries
Belgium
Contacts
Public ContactMarcel NKuize
Outcome results
None listed