NCT01897909

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. 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. 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. 3.To assess the prevalence of H. pylori infection among HIV patients in the Komfo Anokye Teaching Hospital.
  4. 4.To assess the prevalence of gastrointestinal symptoms in HIV patients in Kumasi.
  5. 5.To assess the association of H. pylori infection with gastrointestinal symptoms and pathology in HIV patients.
  6. 6.To compare the clinical and immunological response to antiretroviral therapy and in HIV-patients with and without concomitant H. pylori infection.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,100

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

July 5, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 12, 2013

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2021

Completed
Last Updated

July 29, 2021

Status Verified

July 1, 2021

Enrollment Period

9.7 years

First QC Date

July 5, 2013

Last Update Submit

July 28, 2021

Conditions

HIVBacterial Infection Due to Helicobacter Pylori (H. Pylori)

Outcome Measures

Primary Outcomes (1)

  • T-cell status

    Frequency and activation status of T-cell subsets in HIV positive patients with versus without H. pylori infection

    12 months

Secondary Outcomes (1)

  • CD4 response and virological status

    12 months

Other Outcomes (6)

  • Clinical events

    12 months

  • Prevalence of H. pylori in HIV patients in Kumasi

    12 months

  • Prevalence of infection with helminth and other gastrointestinal parasites in HIV patients in Kumasi

    12 months

  • +3 more other outcomes

Study Arms (3)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • able and willing to give informed written consent
  • age \> 18 years
  • CD4 cells \>350/µl

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Komfo Anokye Teaching Hospital

Kumasi, Ashanti Region, Ghana

Location

Related Publications (2)

  • 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.

    PMID: 27412114DERIVED

  • Eberhardt KA, Sarfo FS, Dompreh A, Kuffour EO, Geldmacher C, Soltau M, Schachscheider M, Drexler JF, Eis-Hubinger AM, Haussinger 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.

    PMID: 26195015DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample, stool sample

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 5, 2013

First Posted

July 12, 2013

Study Start

November 1, 2011

Primary Completion

July 29, 2021

Study Completion

July 29, 2021

Last Updated

July 29, 2021

Record last verified: 2021-07

Locations

GH(1)