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Kumasi Cohort Study (KCS)

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ClinicalTrials.gov Identifier: NCT01853657
Recruitment Status : Active, not recruiting
First Posted : May 15, 2013
Last Update Posted : January 24, 2018
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

Study Description
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Brief Summary:

The main objective is to access efficacy of first and second line antiretroviral therapy (ART) and its determinants in patients treated at the Komfo Anokye Teaching Hospital in Kumasi (KATH), Ghana, and to compare the clinical, virological and immunological efficacy of second line ART in patients who were switched after virological failure compared to patients who were switched after clinical or immunological failure.

Other specific study objectives are:

  1. To establish an HIV Cohort Study at the study site.
  2. To assess the rate of virological failure among patients on first line therapy
  3. To compare the clinical, immunological and virological efficacy of second line antiretroviral therapy amongst patients randomised to virological monitoring whilst on first line compared with those monitored routinely using clinical and immunological monitoring.
  4. To assess the incidence and outcome of tuberculosis (TB) and other opportunistic infections in patients treated at the Komfo Anokye Teaching Hospital HIV services
  5. To obtain parameters for quality of care, e. g. performance of TB screening procedures
  6. To develop strategies to minimise treatment failures, on the basis of the results of the study
  7. To generate a large prospective second-line ART cohort, to serve as basis for further research projects
  8. To implement point-of-care viral load analysis at the Komfo Anokye Teaching Hospital
  9. Capacity building: epidemiology, medical documentation and data base management. Enrollment of one PhD and one Master student

Condition or disease Intervention/treatment Phase
HIV Other: Virological monitoring Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Efficacy of First and Second Line ART in HIV Patients Treated at the Komfo Anokye Teaching Hospital, Kumasi
Study Start Date : June 2012
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Virological monitoring
In addition to routine clinical and immunological monitoring with CD4 counts
 Other: Virological monitoring
No Intervention: Routine monitoring
Immunological and clinical monitoring


Outcome Measures
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Primary Outcome Measures :
  1. Clinical failure [ Time Frame: 12 and 24 months ]

    Combined endpoint is clinical failure 12 and 24 months after switch to second line treatment, defined as:

    1. First/new AIDS defining event
    2. Death


Secondary Outcome Measures :
  1. CD4 response [ Time Frame: 12 and 24 months ]
    Absolute number of CD4 cells at the diagnosis of therapy failure and mean increase in CD4 cell count after 12 or 24 months


Other Outcome Measures:
  1. Frequency and time of therapy changes [ Time Frame: 12 and 24 months ]
  2. Loss-to-follow up [ Time Frame: 12 and 24 months ]
  3. ART-related Adverse Events (AE) [ Time Frame: 12 and 24 months ]
  4. Adherence [ Time Frame: 12 and 24 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • able and willing to give informed written consent
  • age > 18 years
  • on first line ART since > 12 months

Exclusion Criteria:

  • not willing or able to comply with study procedures
Contacts and Locations
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Information from the National Library of Medicine

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): NCT01853657


Locations
Ghana
Komfo Anokye Teaching Hospital
Kumasi, 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: Fred S Sarfo, FWACP, PHD Kwame Nkrumah University of Science and Technology
Principal Investigator: Kirsten A Eberhardt, Dr., MD Bernhard Nocht Institute for Tropical Medicine
More Information
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Publications:

Responsible Party: Kirsten A. Eberhardt, Dr., MD, Bernhard Nocht Institute for Tropical Medicine
ClinicalTrials.gov Identifier: NCT01853657     History of Changes
Other Study ID Numbers: KCS
First Posted: May 15, 2013    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018