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

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of British Columbia
• Collaborator: Health Canada
• Treatments: Didanosine; Tenofovir

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.