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: February 13, 2017

Last verified: February 2017

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:

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
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:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Helicobacter pylori infection

U.S. FDA Resources

Further study details as provided by Kirsten A. Eberhardt, Bernhard Nocht Institute for Tropical Medicine:

Primary Outcome Measures:

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:

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:

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

Blood sample, stool sample


Estimated Enrollment:	1100
Study Start Date:	November 2011
Estimated Study Completion Date:	December 2017
Estimated Primary Completion Date:	December 2017 (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)
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

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):

Mueller-Using S, Feldt T, Sarfo FS, Eberhardt KA. Factors associated with performing tuberculosis screening of HIV-positive patients in Ghana: LASSO-based predictor selection in a large public health data set. BMC Public Health. 2016 Jul 13;16:563. doi: 10.1186/s12889-016-3239-y.

Eberhardt KA, Sarfo FS, Dompreh A, Kuffour EO, Geldmacher C, Soltau M, Schachscheider M, Drexler JF, Eis-Hübinger AM, Häussinger D, Bedu-Addo G, Phillips RO, Norman B, Burchard GD, Feldt T. Helicobacter pylori Coinfection Is Associated With Decreased Markers of Immune Activation in ART-Naive HIV-Positive and in HIV-Negative Individuals in Ghana. Clin Infect Dis. 2015 Nov 15;61(10):1615-23. doi: 10.1093/cid/civ577. Epub 2015 Jul 20.


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:	February 13, 2017

Additional relevant MeSH terms:


Infection Communicable Diseases Bacterial Infections Helicobacter Infections Gram-Negative Bacterial Infections

ClinicalTrials.gov processed this record on August 18, 2017

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