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The Impact of Helicobacter Pylori Infection on Immune Regulation and Clinical Course in HIV Patients in Ghana (HHECO)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Kwame Nkrumah University of Science and Technology
Kumasi Centre for Collaborative Research (KCCR)
Komfo Anokye Teaching Hospital
Universitätsklinikum Hamburg-Eppendorf
Information provided by (Responsible Party):
Kirsten A. Eberhardt, Bernhard Nocht Institute for Tropical Medicine
ClinicalTrials.gov Identifier:
NCT01897909
First received: July 5, 2013
Last updated: July 22, 2015
Last verified: July 2015
History of Changes
  Purpose

The main objective of the study is to investigate the impact of H. pylori infection on immune activation and clinical outcome in HIV patients.

Other specific study objectives are:

  1. To investigate the effects of H. pylori infection on immune activation and the T-cell profile in HIV positive patients and compare those with HIV negative controls.
  2. To assess the influence of H. pylori infection on virological and immune parameters, and on clinical progression of HIV infection (WHO stage, opportunistic infections).
  3. To assess the prevalence of H. pylori infection among HIV patients in the Komfo Anokye Teaching Hospital.
  4. To assess the prevalence of gastrointestinal symptoms in HIV patients in Kumasi.
  5. To assess the association of H. pylori infection with gastrointestinal symptoms and pathology in HIV patients.
  6. To compare the clinical and immunological response to antiretroviral therapy and in HIV-patients with and without concomitant H. pylori infection.

Condition
HIV
Bacterial Infection Due to Helicobacter Pylori (H. Pylori)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Impact of Helicobacter Pylori Infection on Immune Regulation and Clinical Course in HIV Patients in Ghana

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bernhard Nocht Institute for Tropical Medicine:

Primary Outcome Measures:
  • T-cell status [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Frequency and activation status of T-cell subsets in HIV positive patients with versus without H. pylori infection


Secondary Outcome Measures:
  • CD4 response and virological status [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Change of CD4 cells and HIV viral load in HIV positive patients with versus without H. pylori infection during follow-up


Other Outcome Measures:
  • Clinical events [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Incidence of clinical events in HIV positive patients with versus without H. pylori infection during follow-up

  • Prevalence of H. pylori in HIV patients in Kumasi [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Prevalence of infection with helminth and other gastrointestinal parasites in HIV patients in Kumasi [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Prevalence and risk factors for gastrointestinal infections in HIV patients in Kumasi [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Association of gastrointestinal infections with abdominal pain, nausea, diarrhoea, anorexia [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    assessed by a questionnaire

  • Association of gastrointestinal infections with Body Mass Index and Hemoglobin level in HIV patients [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
Blood sample, stool sample

Estimated Enrollment: 1100
Study Start Date: November 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
HIV positive with H. pylori infection
HIV positive patients with H. pylori infection
HIV positive without H. pylori infection
HIV positive patients without H. pylori infection
HIV negative
HIV negative blood donors

  Show Detailed Description

  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The study will be conducted in the HIV outpatient department of the Komfo Anokye Teaching Hospital (KATH), Kumasi, Ghana. The HIV treatment centre offers comprehensive care for HIV patients and regularly attends about 9500 HIV-infected patients.
Criteria

Inclusion Criteria:

  • able and willing to give informed written consent
  • age > 18 years
  • CD4 cells >350/µl

Exclusion Criteria:

  • not willing or able to comply with study procedures
  • HIV2 or HIV1/2 co-infection
  • Active opportunistic infection or other acute systemic infection (e. g. pneumonia) or malignancy ( e. g. lymphoma)
  • Anti-helminth or anti helicobacter pylori treatment in the past 6 months
  • Anemia (Haemoglobin < 7 g/dl)
  • Active systemic or opportunistic infection or tumor (e. g. pneumonia, tuberculosis)
  • Patient is on highly active antiretroviral therapy (HAART) or was on HAART in the 3 months prior to recruitment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01897909

Locations
Ghana
Komfo Anokye Teaching Hospital
Kumasi, Ashanti Region, Ghana
Sponsors and Collaborators
Bernhard Nocht Institute for Tropical Medicine
Kwame Nkrumah University of Science and Technology
Kumasi Centre for Collaborative Research (KCCR)
Komfo Anokye Teaching Hospital
Universitätsklinikum Hamburg-Eppendorf
Investigators
Principal Investigator: Torsten Feldt, MD Bernhard Nocht Institute for Tropical Medicine
Principal Investigator: Kirsten A Eberhardt, MD Bernhard Nocht Institute for Tropical Medicine
Principal Investigator: Fred S Sarfo, FWACP, PHD Kwame Nkrumah University of Science and Technology
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Kirsten A. Eberhardt, MD, Bernhard Nocht Institute for Tropical Medicine
ClinicalTrials.gov Identifier: NCT01897909     History of Changes
Other Study ID Numbers: HHECO 
Study First Received: July 5, 2013
Last Updated: July 22, 2015
Health Authority: Ghana: Committee on Human Research

Additional relevant MeSH terms:
Infection
Communicable Diseases
Bacterial Infections
Helicobacter Infections
Gram-Negative Bacterial Infections

ClinicalTrials.gov processed this record on September 29, 2016