The Impact of Helicobacter Pylori Infection on Immune Regulation and Clinical Course in HIV Patients in Ghana
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,100
- Locations
- 1
- Primary Endpoint
- T-cell status
Study Overview
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:
- 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.
Detailed Description
Study design:
Observational case control study with longitudinal follow up
Recruitment:
1000 HIV patients regularly attending to the KATH HIV clinic will be screened for H. pylori infection and other parasitic gastrointestinal infections (as possible confounders). Demographic, clinical and immunological data of those patients will be documented by study physicians.
Two groups with each 100 patients with H. pylori infection and 100 patients without H. pylori infection are then selected, matched according to sex, age, baseline HIV viral load, CD4 cell count and other confounders.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
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 Outcomes
- CD4 response and virological status(12 months)
Investigators
Kirsten A. Eberhardt
MD
Bernhard Nocht Institute for Tropical Medicine