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
: January 24, 2018
|
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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:
- 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.
- To assess the influence of H. pylori infection on virological and immune parameters, and on clinical progression of HIV infection (WHO stage, opportunistic infections).
- To assess the prevalence of H. pylori infection among HIV patients in the Komfo Anokye Teaching Hospital.
- To assess the prevalence of gastrointestinal symptoms in HIV patients in Kumasi.
- To assess the association of H. pylori infection with gastrointestinal symptoms and pathology in HIV patients.
- To compare the clinical and immunological response to antiretroviral therapy and in HIV-patients with and without concomitant H. pylori infection.
Condition or disease |
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HIV Bacterial Infection Due to Helicobacter Pylori (H. Pylori) |

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 2018 |
Estimated Study Completion Date : | December 2018 |

Group/Cohort |
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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
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- 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
- 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
- Clinical events [ Time Frame: 12 months ]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 ]
- Prevalence of infection with helminth and other gastrointestinal parasites in HIV patients in Kumasi [ Time Frame: 12 months ]
- Prevalence and risk factors for gastrointestinal infections in HIV patients in Kumasi [ Time Frame: 12 months ]
- Association of gastrointestinal infections with abdominal pain, nausea, diarrhoea, anorexia [ Time Frame: 12 months ]assessed by a questionnaire
- Association of gastrointestinal infections with Body Mass Index and Hemoglobin level in HIV patients [ Time Frame: 12 months ]
Biospecimen Retention: Samples With DNA

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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 |
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

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
Ghana | |
Komfo Anokye Teaching Hospital | |
Kumasi, Ashanti Region, Ghana |
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 |
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 |
First Posted: | July 12, 2013 Key Record Dates |
Last Update Posted: | January 24, 2018 |
Last Verified: | January 2018 |
Additional relevant MeSH terms:
Infection Communicable Diseases Bacterial Infections Helicobacter Infections Gram-Negative Bacterial Infections |