Antiretroviral Switch From Didanosine to Tenofovir in HIV/HCV co-Infected Patients - Full Text View

Sponsors and Collaborators:	University of British Columbia Health, Canada
Information provided by:	University of British Columbia
ClinicalTrials.gov Identifier:	NCT00358696

Purpose

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	Intervention	Phase
HIV HIV Infections	Drug: tenofovir	Phase IV

MedlinePlus related topics: AIDS Hepatitis Hepatitis C

Drug Information available for: Didanosine Tenofovir Tenofovir disoproxil Tenofovir Disoproxil Fumarate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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.

Further study details as provided by University of British Columbia:

Primary Outcome Measures:

Virologic Suppression [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

HAART adherence, safety, CD4 cell count [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	July 2006
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Intervention Details:

See Detailed Description.

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

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00358696

Contacts

Contact: Lesley Gallagher, RN

lgallagher@interchange.ubc.ca

Locations

Canada, British Columbia
Pender Community Health Centre	Recruiting
Vancouver, British Columbia, Canada
Contact: Lesley Gallagher, RN
Principal Investigator: Brian Conway, MD

Sponsors and Collaborators

University of British Columbia

Health, Canada

Investigators

Principal Investigator:

Dr. Brian Conway, MD

University of British Columbia

More Information

Responsible Party:	University of British Columbia ( Dr. Brian Conway )
Study ID Numbers:	C05-0218
Study First Received:	July 28, 2006
Last Updated:	September 23, 2008
ClinicalTrials.gov Identifier:	NCT00358696
Health Authority:	Canada: Health Canada

Keywords provided by University of British Columbia:

tenofovir
didanosine
hiv
hepatitis c virus infection
treatment

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Sexually Transmitted Diseases, Viral
Didanosine
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Tenofovir
Hepatitis C
Retroviridae Infections
Immunologic Deficiency Syndromes
Tenofovir disoproxil

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors

Infection
Antiviral Agents
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009