Condition category
Infections and Infestations
Date applied
24/09/2020
Date assigned
12/10/2020
Last edited
30/09/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Helicobacter pylori (HP) infection, a cause of ulcers and cancer in the stomach, and ulcers in the intestines, is frequent worldwide and treatment is well established in the general population. By contrast, little is known about how HP infection is treated among people living with HIV infection (PLWHIV). Therefore, the aim of this study is to evaluate the types of treatments used and the outcomes for PLWHIV treated for HP infection, to identify patient and disease factors that can increase the risk of treatment failure.

Who can participate?
Adult outpatients aged 18 or more who have a proven HP infection in a recent test and have not yet been treated for HP infection treatment, and who have HIV or do not have HIV, will be invited to participate in the study.

What does the study involve?
Participants will be treated for HP infection according to the current standard of care, a combination of antibiotics and proton pump inhibitor medications. Participants will be asked, using oral questionnaire about side effects (chest, digestive, general symptoms, and quality of live) during the treatment course and after cessation. Participants will then be invited back to the clinic several weeks after cessation of treatment to undergo follow-up tests in order to verify whether or not they are cured.
Participants who are HIV-infected, since October 10th, 2017 receive a support material and phone call during treatment course to hear their thoughts on the treatment side effects, and to coach their treatment.

What are the possible benefits and risks of participating?
There is no direct benefit of taking part in the study. Patients will receive the same level of care whether they choose or not choose to participate in the study, thus so there is no additional risk related to their participation in the study. The indirect benefit for the patient will be easy access to investigators and care, close follow-up with immediate support in case of side effects, and care until free of H. pylori infection

Where is the study run from?
The study will be run from University hospital Saint Pierre in Brussels (Belgium), Gastroenterology and Infectious diseases Departments

When is the study starting and how long is it expected to run for?
January 2006 to December 2023.

Who is funding the study
The study is self-funded with the support of the University Hospital Saint Pierre (Belgium).

Who is the main contact?
Dr Marcel Nkuize, marcel.nkuize@stpierre-bru.be

Trial website

Contact information

Type

Public

Primary contact

Dr Marcel NKuize

ORCID ID

http://orcid.org/0000-0002-7708-050X

Contact details

322 Rue Haute
Brussels
1000
Belgium
+32 25354658
marcel.nkuize@stpierre-bru.be

Type

Scientific

Additional contact

Dr Marcel NKuize

ORCID ID

Contact details

322 Rue Haute
Brussels
1000
Belgium
+32 25354658
marcel.nkuize@stpierre-bru.be

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

B07620083330, B076201733646

Study information

Scientific title

H. pylori treatment in HIV co-infected individuals with immunodepression

Acronym

OHpTHIV

Study hypothesis

The treatment of Helicobacter pylori (HP) infection is widely studied, in particular among the general population. The study aims to investigate HP treatment in HIV co-infected individuals to determine whether they can be treated similarly to the general population.

Ethics approval

1. Approved 08/01/2008, Comité Local d'Ethique Hospitalier (Rue Haute 322-1000 Brussels, +32 25354481; comite_ethique@stpierre-bru.be), ref: B07620083330
2. Approved 10/10/2017, Comité Local d'Ethique Hospitalier (Rue Haute 322-1000 Brussels, +32 25354481; comite_ethique@stpierre-bru.be), ref: B076201733646

Study design

Longitudinal case control single center registry

Primary study design

Observational

Secondary study design

Longitudinal study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Helicobacter pylori infection

Intervention

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 6 weeks after treatment completion.

Types of treatment and drug dose:
1. Standard triple therapy: a PPI plus two antibiotics (amoxicillin (AMX) 1000 mg, clarithromycin (CLA) 500 mg, or metronidazole (MET) 500 mg) twice daily for 7 to 14 days
2. Sequential therapy: a PPI plus AMX 1000 mg twice daily for 5 days followed by a PPI plus CLA 500 mg and MET 500 mg twice daily for 5 days
3. Quadruple therapy pharmacy preparation of capsules: including tetracycline (TET)-chlorhydrate 500 mg plus colloidal bismuth sub-citrate 500 mg four times daily, MET 500 mg three times daily, and PPI twice daily for 10 days
4. Another quadruple therapy: single pill formulation: containing bismuth sub-citrate 140 mg/TET-chlorhydrate 125 mg/MET 125 mg (three pills to take four times daily) plus one PPI (twice daily) for 10 days
5. Concomitant therapy (CoT): PPI plus three antibiotics (AMX 1000 mg, CLA 500 mg, MET 500 mg) twice daily for 14 days. Proton pump inhibitors will be esomeprazole 40 mg, lansoprazole 30 mg, omeprazole 20 mg or 40 mg, pantoprazole 40 mg or rabeprazole 20 mg

Intervention type

Drug

Phase

Not Applicable

Drug names

1. Amoxicillin
2. Bismuth
3. Clarithromycin
4. Levofloxacin
5. Metronidazole
6. Tetracycline
7. Esomeprazole
8. Lansoprazole
9. Omeprazole
10. Rabeprazole
11. Pantoprazole

Primary outcome measure

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 outcome measures

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

Overall trial start date

01/01/2006

Overall trial end date

31/12/2023

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

500

Participant 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)

Recruitment start date

01/01/2008

Recruitment end date

31/12/2022

Locations

Countries of recruitment

Belgium

Trial participating centre

University Hospital Saint Peter
322 Rue Haute
Brussels
1000
Belgium

Sponsor information

Organisation

Centre Hospitalier Universitaire de Saint-Pierre

Sponsor details

322 Rue Haute
Brussels
1000
Belgium
+32 25354109
infectiousdiseases@stpierre-bru.be

Sponsor type

Hospital/treatment centre

Website

https://www.stpierre-bru.be/

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Centre Hospitalier Universitaire de Saint-Pierre

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication of results in a high impact-factor journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request (Nkuize M. at marcel.nkuize@stpierre-bru.be) six months after the publication of study results. Datasets are confidential and any data sharing will have to go through the Medical Research Ethic Committee at University Hospital Saint Peter.

Intention to publish date

30/03/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

25/09/2020: Trial’s existence confirmed by Centre Hospitalier Universitaire de Saint-Pierre.