Antiretroviral Switch From Didanosine to Tenofovir in HIV/HCV Co-infected Patients
|ClinicalTrials.gov Identifier: NCT00358696|
Recruitment Status : Completed
First Posted : August 1, 2006
Last Update Posted : October 20, 2009
|Condition or disease||Intervention/treatment||Phase|
|HIV HIV Infections||Drug: tenofovir||Phase 4|
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 assess the safety and tolerability over 12 weeks in patients switched to tenofovir.
Research Method - This will be a single arm observational study to include 30 subjects. Patients requiring HCV treatment will be assessed and patients receiving didanosine will be clinically evaluated to determine an appropriate NRTI drug switch. Patients who are to switch the didanosine component of their regimen to tenofovir will be eligible to participate in the study and will be followed for a period of observation of up to 4 weeks. All patients will be receiving tenofovir as one capsule, once daily. The primary endpoint will be maintenance of virologic suppression between the Baseline visit and week 12 in the overall study group. Measures of adherence to HAART, safety, tolerability and CD4 cell counts will also be obtained at each study visit, and will constitute secondary study endpoints.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||TEN Switch - An Observational Phase IV Study to Evaluate the Safety and Efficacy of Substituting Tenofovir for Didanosine in Virologically Controlled HIV-infected Patients Co-infected With Hepatitis C Virus.|
|Study Start Date :||July 2006|
|Primary Completion Date :||October 2009|
|Study Completion Date :||October 2009|
- Virologic Suppression
- HAART adherence, safety, CD4 cell count
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): NCT00358696
|Canada, British Columbia|
|Pender Community Health Centre|
|Vancouver, British Columbia, Canada|
|Principal Investigator:||Dr. Brian Conway, MD||University of British Columbia|