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

HIV Infections Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00358696
• Other study ID #: C05-0218
• Status: Completed
• Phase: Phase 4
• First received: July 28, 2006
• Last updated: October 19, 2009
• Start date: July 2006
• Est. completion date: October 2009

Study information

• Verified date: October 2009
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV
• HIV Infections

Intervention

Drug:
• tenofovir
See Detailed Description.

Locations

Country	Name	City	State
Canada	Pender Community Health Centre	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Health Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Virologic Suppression		Unspecified	No
Secondary	HAART adherence, safety, CD4 cell count		Unspecified	No