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

NCT00358696 | Completed Phase 4

• 1 other identifier: C05-0218
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV; HIV Infections

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Virologic Suppression

Secondary Outcomes (1)

• HAART adherence, safety, CD4 cell count

Interventions

tenofovir DRUG

See Detailed Description.

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be age 19 or older;
• Have a confirmed diagnosis of HIV infection;
• Have a confirmed positive HCV RNA PCR;
• Have two consecutive HIV RNA levels \<50 copies/mL with the most recent within the past 3 months;
• Must not exhibit evidence of an acute illness, including an acute opportunistic infection;
• Must not have any evidence of grade 3-4 laboratory abnormalities;
• Must be able and willing to provide informed consent.

You may not qualify if:

• Be receiving investigational drug within 30 days prior to beginning this study;
• If female, be pregnant or breast-feeding;
• In the opinion of the investigator, is unlikely to comply with the study protocol or is unsuitable for participation for any reason.

Sponsors & Collaborators

• University of British Columbia: lead
• Health Canada: collaborator

Study Sites (1)

Pender Community Health Centre

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome; Hepatitis C

Interventions

Tenofovir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; Hepatitis, Viral, Human; Flaviviridae Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Dr. Brian Conway, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 28, 2006
• First Posted: August 1, 2006
• Study Start: July 1, 2006
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: October 20, 2009

Record last verified: 2009-10

Locations

CA (1)