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Kumasi Cohort Study (KCS)
This study is ongoing, but not recruiting participants.
Sponsor:
Bernhard Nocht Institute for Tropical Medicine
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: February 13, 2017
Last verified: February 2017
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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:
- To establish an HIV Cohort Study at the study site.
- To assess the rate of virological failure among patients on first line therapy
- 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.
- To assess the incidence and outcome of tuberculosis (TB) and other opportunistic infections in patients treated at the Komfo Anokye Teaching Hospital HIV services
- To obtain parameters for quality of care, e. g. performance of TB screening procedures
- To develop strategies to minimise treatment failures, on the basis of the results of the study
- To generate a large prospective second-line ART cohort, to serve as basis for further research projects
- To implement point-of-care viral load analysis at the Komfo Anokye Teaching Hospital
- 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 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 |
Resource links provided by NLM:
Further study details as provided by Kirsten A. Eberhardt, Bernhard Nocht Institute for Tropical Medicine:
Primary Outcome Measures:
- 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:
- First/new AIDS defining event
- Death
Secondary Outcome Measures:
- 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:
- Frequency and time of therapy changes [ Time Frame: 12 and 24 months ]
- Loss-to-follow up [ Time Frame: 12 and 24 months ]
- ART-related Adverse Events (AE) [ Time Frame: 12 and 24 months ]
- Adherence [ Time Frame: 12 and 24 months ]
| Estimated Enrollment: | 3000 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | December 2017 |
| Estimated Primary Completion Date: | December 2017 (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 (Adult, Senior) |
| 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
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
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: | February 13, 2017 |
ClinicalTrials.gov processed this record on September 21, 2017