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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00358696
Recruitment Status : Completed
First Posted : August 1, 2006
Last Update Posted : October 20, 2009
Health Canada
Information provided by:
University of British Columbia

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 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 or disease Intervention/treatment Phase
HIV HIV Infections Drug: tenofovir Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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.
Study Start Date : July 2006
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Intervention Details:
  • Drug: tenofovir
    See Detailed Description.

Primary Outcome Measures :
  1. Virologic Suppression

Secondary Outcome Measures :
  1. HAART adherence, safety, CD4 cell count

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00358696

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Canada, British Columbia
Pender Community Health Centre
Vancouver, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
Health Canada
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Principal Investigator: Dr. Brian Conway, MD University of British Columbia
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Responsible Party: Dr. Brian Conway, University of British Columbia Identifier: NCT00358696    
Other Study ID Numbers: C05-0218
First Posted: August 1, 2006    Key Record Dates
Last Update Posted: October 20, 2009
Last Verified: October 2009
Keywords provided by University of British Columbia:
hepatitis c virus infection
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents