Antiretroviral Switch From Didanosine to Tenofovir in HIV/HCV Co-infected Patients
Information source: University of British Columbia
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV; HIV Infections
Intervention: tenofovir (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of British Columbia Official(s) and/or principal investigator(s): Dr. Brian Conway, MD, Principal Investigator, Affiliation: University of British Columbia
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.
Clinical Details
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 design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Virologic Suppression
Secondary outcome: HAART adherence, safety, CD4 cell count
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.
Eligibility
Minimum age: 19 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Pender Community Health Centre, Vancouver, British Columbia, Canada
Additional Information
Starting date: July 2006
Last updated: October 19, 2009
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