Clinical Trials


Antiretroviral Switch From Didanosine to Tenofovir in HIV/HCV Co-infected Patients

This study has been completed
University of British Columbia

Health Canada

Information provided by (Responsible Party)
University of British Columbia Identifier

First received: July 28, 2006
Last updated: October 19, 2009
Last Verified: October 2009
History of Changes


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 virologic suppression on a double class regimen (including two NRTIs and an NNRTI or a PI, boosted with RTV or not), a single drug substitution of didanosine for tenofovir will represent a viable strategy without any negative impact on the virologic efficacy of the regimen.

Condition Intervention Phase
HIV Infections

Drug : tenofovir
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.

Further study details as provided by University of British Columbia:

Primary Outcome Measures

  • Virologic Suppression
Secondary Outcome Measures:
  • HAART adherence, safety, CD4 cell count

Enrollment: 30
Study Start Date: July 2006
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)

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 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.



Ages Eligible for Study: 19 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  


Inclusion Criteria:

    1. Be age 19 or older;
    2. Have a confirmed diagnosis of HIV infection;
    3. Have a confirmed positive HCV RNA PCR;
    4. Have two consecutive HIV RNA levels <50 copies/mL with the most recent within the past 3 months;
    5. Must not exhibit evidence of an acute illness, including an acute opportunistic infection;
    6. Must not have any evidence of grade 3-4 laboratory abnormalities;
    7. Must be able and willing to provide informed consent.

Exclusion Criteria:
    1. Be receiving investigational drug within 30 days prior to beginning this study;
    2. If female, be pregnant or breast-feeding;
    3. In the opinion of the investigator, is unlikely to comply with the study protocol or
    is unsuitable for participation for any reason.

contacts and locations

Contacts and Locations

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Please refer to this study by its identifier: NCT00358696


Pender Community Health Centre
Vancouver, British Columbia, Canada

Sponsors and Collaborators

University of British Columbia
Health Canada


Principal Investigator: Dr. Brian Conway, MD University of British Columbia
More Information

More Information

Responsible Party: Dr. Brian Conway, University of British Columbia Identifier: NCT00358696   History of Changes  
Other Study ID Numbers: C05-0218  
Study First Received: July 28, 2006  
Last Updated: October 19, 2009  

Keywords provided by University of British Columbia:

hepatitis c virus infection

Additional relevant MeSH terms:
HIV Infections
Didanosine processed this data on February 15, 2019
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