Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
University of British Columbia Health, Canada |
---|---|
Information provided by: | University of British Columbia |
ClinicalTrials.gov Identifier: | NCT00358696 |
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 HIV Infections |
Drug: tenofovir |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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. |
Estimated Enrollment: | 30 |
Study Start Date: | July 2006 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
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 |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lesley Gallagher, RN | lgallagher@interchange.ubc.ca |
Canada, British Columbia | |
Pender Community Health Centre | Recruiting |
Vancouver, British Columbia, Canada | |
Contact: Lesley Gallagher, RN | |
Principal Investigator: Brian Conway, MD |
Principal Investigator: | Dr. Brian Conway, MD | University of British Columbia |
Responsible Party: | University of British Columbia ( Dr. Brian Conway ) |
Study ID Numbers: | C05-0218 |
Study First Received: | July 28, 2006 |
Last Updated: | September 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00358696 History of Changes |
Health Authority: | Canada: Health Canada |
tenofovir didanosine hiv hepatitis c virus infection treatment |
Antimetabolites Sexually Transmitted Diseases, Viral Anti-HIV Agents Acquired Immunodeficiency Syndrome Antiviral Agents Immunologic Deficiency Syndromes Reverse Transcriptase Inhibitors Hepatitis Virus Diseases |
Didanosine Anti-Retroviral Agents HIV Infections Sexually Transmitted Diseases Tenofovir Hepatitis C Retroviridae Infections Tenofovir disoproxil |
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Tenofovir Retroviridae Infections Nucleic Acid Synthesis Inhibitors Tenofovir disoproxil |
RNA Virus Infections Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases Didanosine HIV Infections Sexually Transmitted Diseases Lentivirus Infections |