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

• ClinicalTrials.gov Identifier: NCT00358696
• Recruitment Status: Completed
• First Posted: August 1, 2006
• Last Update Posted: October 20, 2009
• Sponsor: University of British Columbia
• Collaborator: Health Canada
• Information provided by: University of British Columbia

Study Description

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.

Study Design

• 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

Arms and Interventions

Intervention Details:

• Drug: tenofovir
  See Detailed Description.

Outcome Measures

Primary Outcome Measures :

1. Virologic Suppression

Secondary Outcome Measures :

1. HAART adherence, safety, CD4 cell count

Eligibility Criteria

• Ages Eligible for Study: 19 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Canada, British Columbia

Pender Community Health Centre

Vancouver, British Columbia, Canada

Sponsors and Collaborators

University of British Columbia

Health Canada

Investigators

• Principal Investigator: Dr. Brian Conway, MD; University of British Columbia

More Information

• Responsible Party: Dr. Brian Conway, University of British Columbia
• ClinicalTrials.gov Identifier: NCT00358696
• Other Study ID Numbers: C05-0218
• First Posted: August 1, 2006
• Last Update Posted: October 20, 2009
• Last Verified: October 2009

Keywords provided by University of British Columbia:

tenofovir; didanosine; hiv; hepatitis c virus infection; treatment

Additional relevant MeSH terms:

Infection; HIV Infections; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Tenofovir; 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