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

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ClinicalTrials.gov Identifier: NCT01897909
Recruitment Status : Active, not recruiting
First Posted : July 12, 2013
Last Update Posted : February 14, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease
HIV Bacterial Infection Due to Helicobacter Pylori (H. Pylori)

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Study Design

Study Type : Observational
Estimated Enrollment : 1100 participants
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
Study Start Date : November 2011
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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


Outcome Measures

Primary Outcome Measures :
  1. T-cell status [ Time Frame: 12 months ]
    Frequency and activation status of T-cell subsets in HIV positive patients with versus without H. pylori infection


Secondary Outcome Measures :
  1. CD4 response and virological status [ Time Frame: 12 months ]
    Change of CD4 cells and HIV viral load in HIV positive patients with versus without H. pylori infection during follow-up


Other Outcome Measures:
  1. Clinical events [ Time Frame: 12 months ]
    Incidence of clinical events in HIV positive patients with versus without H. pylori infection during follow-up

  2. Prevalence of H. pylori in HIV patients in Kumasi [ Time Frame: 12 months ]
  3. Prevalence of infection with helminth and other gastrointestinal parasites in HIV patients in Kumasi [ Time Frame: 12 months ]
  4. Prevalence and risk factors for gastrointestinal infections in HIV patients in Kumasi [ Time Frame: 12 months ]
  5. Association of gastrointestinal infections with abdominal pain, nausea, diarrhoea, anorexia [ Time Frame: 12 months ]
    assessed by a questionnaire

  6. Association of gastrointestinal infections with Body Mass Index and Hemoglobin level in HIV patients [ Time Frame: 12 months ]

Biospecimen Retention:   Samples With DNA
Blood sample, stool sample

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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