Status:
COMPLETED
Antiretroviral Switch From Didanosine to Tenofovir in HIV/HCV Co-infected Patients
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
Health Canada
Conditions:
HIV
HIV Infections
Eligibility:
All Genders
19+ years
Phase:
PHASE4
Brief Summary
The primary purpose of this study is to evaluate the impact of changing didanosine in an effective anti-HIV regimen to tenofovir on virologic suppression. We hypothesize that, in patients with maximal...
Detailed Description
Primary objective - to determine the impact of changing part of an effective HAART regimen to tenofovir on maintenance of virologic suppression in HCV co-infected patients. Secondary objective - to a...
Eligibility Criteria
Inclusion
- Be age 19 or older;
- Have a confirmed diagnosis of HIV infection;
- Have a confirmed positive HCV RNA PCR;
- Have two consecutive HIV RNA levels \<50 copies/mL with the most recent within the past 3 months;
- Must not exhibit evidence of an acute illness, including an acute opportunistic infection;
- Must not have any evidence of grade 3-4 laboratory abnormalities;
- Must be able and willing to provide informed consent.
Exclusion
- Be receiving investigational drug within 30 days prior to beginning this study;
- If female, be pregnant or breast-feeding;
- In the opinion of the investigator, is unlikely to comply with the study protocol or is unsuitable for participation for any reason.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00358696
Start Date
July 1 2006
End Date
October 1 2009
Last Update
October 20 2009
Active Locations (1)
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1
Pender Community Health Centre
Vancouver, British Columbia, Canada