The Impact of Helicobacter Pylori Infection on Immune Regulation and Clinical Course in HIV Patie… (NCT01897909) | Clinical Trial Compass
CompletedNot Applicable
The Impact of Helicobacter Pylori Infection on Immune Regulation and Clinical Course in HIV Patients in Ghana
Ghana1,100 participantsStarted 2011-11
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
T-cell status
Timeframe: 12 months
Trial details
NCT IDNCT01897909
SponsorBernhard Nocht Institute for Tropical Medicine