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Kumasi Cohort Study (KCS)

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:
NCT01853657
First received: May 8, 2013
Last updated: September 1, 2014
Last verified: September 2014
History of Changes
  Purpose

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 Intervention
HIV
 Other: Virological monitoring

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bernhard Nocht Institute for Tropical Medicine:

Primary Outcome Measures:
  • Clinical failure [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]

    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:
  • CD4 response [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
    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:
  • Frequency and time of therapy changes [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • Loss-to-follow up [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • ART-related Adverse Events (AE) [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • Adherence [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
Estimated Enrollment: 3000
Study Start Date: June 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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

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
Study First Received: May 8, 2013
Last Updated: September 1, 2014
Health Authority: Ghana: Committee on Human Research

ClinicalTrials.gov processed this record on March 01, 2015